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Top 10 CE Marking Consultants for MDR and IVDR in USA (2026)

ShareThoughts — Fri, 08 May 2026 09:15:54 +0000

Top 10 CE Marking Consultants for MDR and IVDR in USA (2026)

Finding the right CE Marking consultant for EU MDR or IVDR compliance can make or break your market entry into Europe. With over 3,000 US medical device and IVD manufacturers actively pursuing CE Marking under the new EU MDR 2017/745 and IVDR 2017/746 regulations, choosing an experienced regulatory partner has never been more critical. This guide ranks the Top 10 CE Marking Consultants for MDR and IVDR in the USA in 2026 — evaluated on regulatory depth, Notified Body relationships, technical documentation expertise, and proven client outcomes.

“Whether you manufacture a low risk Class I device or higher class IIa, IIb or Class III implantable device or a low risk class A/B, or higher risk class C/D IVD, this guide helps you identify the right CE Marking consultant matched to your device type, regulatory pathway, and budget.”

The need and urgency of finding right consulting firms increased dramatically after the release of New EU MDR 2017/745 and EU IVDR 2017/746.

What Is CE Marking and Why Do US Manufacturers Need It?

CE Marking is a mandatory regulatory certification that allows medical devices and in vitro diagnostic (IVD) products to be legally sold across all 27 European Union member states, as well as in EEA countries including Norway, Iceland, and Liechtenstein. The “CE” stands for Conformité Européenne — French for European Conformity — and the CE Mark on a device signals to regulators, healthcare providers, and patients that the product meets all applicable EU safety, performance, and quality requirements.

For US medical device and IVD manufacturers, CE Marking is not optional — it is the only legal pathway to market entry in Europe. Without it, no US manufacturer can sell, distribute, or clinically deploy their device anywhere in the EU, regardless of whether the product already holds FDA 510(k) clearance or PMA approval. FDA clearance carries no automatic recognition or equivalence in Europe. The two regulatory systems are entirely independent, and US manufacturers must meet EU requirements in full.

What CE Marking Means Under EU MDR 2017/745

The EU Medical Device Regulation (MDR) 2017/745 replaced the legacy Medical Device Directive (MDD 93/42/EEC) and has been fully enforced since May 2021 for new devices, with extended transition deadlines for legacy MDD-certified devices running through 2028. Under MDR, CE Marking requirements are significantly more demanding than under the old MDD framework.

What CE Marking Means Under EU IVDR 2017/746

The EU In Vitro Diagnostic Regulation (IVDR) 2017/746 replaced the In Vitro Diagnostic Directive (IVDD 98/79/EC) and introduced a sweeping overhaul of how IVD devices are regulated in Europe. IVDR is widely regarded as one of the most demanding regulatory transitions in the history of the IVD industry, with the vast majority of previously self-certified IVDs now requiring Notified Body involvement for the first time.

Why USA Based Medical Device Companies Must Comply

The European medical device market is the second largest in the world, valued at over €120 billion, and represents a critical revenue opportunity for US manufacturers seeking international market expansion. Beyond revenue, CE Marking unlocks access to:

All 27 EU member states with a single certification — no country-by-country approvals
EEA markets — Norway, Iceland, Liechtenstein
Mutual recognition markets — several non-EU countries accept CE Marking as a baseline for their own approval processes, including Switzerland, Turkey, and the UK (UKCA transitional arrangements)
Investor and acquirer confidence — CE Marking is often a prerequisite for Series B/C funding rounds and M&A due diligence in the medical device sector
Clinical study access — CE Marking enables participation in EU-based clinical investigations and registry studies

For US manufacturers already holding FDA clearance, CE Marking is the natural next step in a global market access strategy. However, the technical, clinical, and regulatory gap between FDA and EU MDR/IVDR requirements is substantial — and attempting CE Marking without experienced consultants significantly increases the risk of Notified Body rejection, costly rework, and delayed market entry.

What Does a CE Marking Consultant Do for MDR and IVDR?

Technical Documentation Preparation
Clinical Evaluation and Performance Evaluation Reports
Notified Body Selection and Liaison
Post-Market Surveillance (PMS) and Vigilance Support
EUDAMED Registration and UDI Implementation

List of Top 10 CE Marking Consultants in USA (2026)

MEDDEVICECORP

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EMERGO

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I3CGLOBAL

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RQM+

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RQM+

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FREYR

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REGHELPS

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CASCUS

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RCA PROMPT

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PROPHARMA

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How to Choose the Right CE Marking Consultant for MDR or IVDR

Choosing the right CE Marking consultant for EU MDR 2017/745 or EU IVDR 2017/746 is critical for successful European market entry. An experienced consultant can help manufacturers avoid Notified Body rejections, costly delays, and technical documentation deficiencies. Before selecting a consulting firm, manufacturers should evaluate the company’s experience with MDR or IVDR projects, clinical and performance evaluation capabilities, technical documentation expertise, and ability to support interactions with Notified Bodies.

It is also important to understand whether your product falls under MDR or IVDR, as both regulations require different technical and regulatory expertise. MDR applies to medical devices such as implants, instruments, and software, while IVDR applies to in vitro diagnostic devices including test kits, reagents, and diagnostic software. Manufacturers should always ask consultants about their specific MDR and IVDR project experience, completed CE Marking submissions, and expertise in areas such as CER, PER, PMCF, risk management, and performance evaluation.

Key Criteria for Evaluating CE Marking Consultants

EU Regulatory Depth vs General Medical Device Experience: Manufacturers should choose consultants with direct experience in EU MDR 2017/745 and EU IVDR 2017/746 rather than only general medical device regulatory knowledge. Look for proven MDR/IVDR Technical Documentation, CER/PER preparation, MDCG guidance understanding, and successful Notified Body submissions.

Notified Body Relationships and Audit Track Record: Experienced consultants understand the expectations of different Notified Bodies and can support manufacturers during audits, document reviews, and deficiency responses. Manufacturers should evaluate the consultant’s experience with specific Notified Bodies and their MDR/IVDR submission track record.

Technical Documentation and CER/PER Writing Capability: Technical Documentation, CER, and PER quality play a major role in CE Marking success. A strong consultant should have expertise in Annex II and III documentation, clinical evaluation, performance evaluation, risk management, PMS, and PMCF activities aligned with current MDR/IVDR expectations.

Flexible Engagement Models — Project-Based vs Retainer: MDR and IVDR compliance require ongoing support beyond initial certification. Manufacturers should look for consultants offering flexible models such as project-based services, modular support, or long-term assistance for PMS, PMCF, PSUR, and regulatory maintenance activities.

MDR and IVDR CE Marking Process: A Step-by-Step Overview for US Manufacturers

Achieving CE Marking under EU MDR 2017/745 or EU IVDR 2017/746 is a detailed regulatory journey that can take anywhere from 12 to 36 months, depending on the device class, technical complexity, and Notified Body timelines. For many US manufacturers entering the European market for the first time, the process can feel complex due to the extensive documentation, clinical evidence, and ongoing compliance requirements involved.

Understanding the major stages of the CE Marking process helps manufacturers plan resources, timelines, and regulatory strategy more effectively. Experienced CE Marking consultants often play an important role by guiding manufacturers through classification, Technical Documentation, CER or PER preparation, Notified Body coordination, and post-market compliance activities. While the overall pathway is similar for MDR and IVDR, certain requirements differ depending on whether the product is a medical device or an in vitro diagnostic device.

Step 1 — Device Classification Under MDR or IVDR

The CE Marking process begins with proper device classification under EU MDR 2017/745 or EU IVDR 2017/746. Classification determines the conformity assessment pathway, level of Notified Body involvement, and the amount of clinical or performance evidence required for certification.

Under MDR, medical devices are classified into Class I, IIa, IIb, and III based on factors such as intended use, invasiveness, duration of contact, and risk level. Under IVDR, IVD devices are classified into Class A, B, C, and D according to patient and public health risk. Many US manufacturers mistakenly apply FDA classification logic to EU regulations, which can lead to incorrect regulatory strategies and delays. Experienced CE Marking consultants help manufacturers accurately classify devices according to MDR or IVDR Annex VIII requirements and relevant MDCG guidance.

Step 2 — General Safety and Performance Requirements (GSPR) Gap Analysis

After device classification, manufacturers must perform a gap analysis against the General Safety and Performance Requirements (GSPR) outlined in Annex I of EU MDR 2017/745 or EU IVDR 2017/746. This process evaluates whether the existing technical documentation, risk management files, clinical evidence, labeling, and quality system meet EU regulatory expectations.

A comprehensive GSPR gap analysis typically reviews areas such as ISO 14971 risk management, IEC 62304 software lifecycle documentation, IEC 62366 usability engineering, ISO 10993 biocompatibility, sterility validation, labeling compliance, and CER or PER readiness. For many US manufacturers, FDA documentation alone is not sufficient to meet MDR or IVDR requirements, making remediation and document restructuring necessary before CE Marking submission.

Step 3 — Technical Documentation Preparation

Technical Documentation is the core submission package required for CE Marking under EU MDR 2017/745 and EU IVDR 2017/746. It demonstrates that the device meets applicable safety, performance, and regulatory requirements. The documentation typically includes device description, design and manufacturing information, GSPR checklist, risk management, verification and validation reports, labeling, PMS documentation, and clinical or performance evaluation evidence.

Under MDR, manufacturers must prepare a Clinical Evaluation Report (CER) supported by clinical data and benefit-risk analysis. Under IVDR, the focus shifts to the Performance Evaluation Report (PER), including scientific validity, analytical performance, and clinical performance data. Technical Documentation preparation is often the most demanding stage of the CE Marking process, and experienced consultants play a key role in developing compliant CER, PER, PMS, and risk management documentation aligned with current Notified Body expectations.

Step 4 — Quality Management System Alignment

Manufacturers pursuing CE Marking under EU MDR 2017/745 or EU IVDR 2017/746 must operate a Quality Management System (QMS) compliant with ISO 13485:2016. For higher-risk devices, the Notified Body will assess the manufacturer’s QMS during the conformity assessment process. While FDA QSR requirements provide a strong foundation for US manufacturers, additional alignment with ISO 13485 and EU regulatory expectations is usually required.

Common areas requiring updates include design and development controls, post-market surveillance integration, complaint handling, supplier management, and field safety corrective action procedures. Manufacturers without ISO 13485 certification are advised to implement and certify their QMS early in the CE Marking process to avoid delays during Notified Body audits.

Step 5 — Notified Body Selection and Submission

For higher-risk devices under EU MDR 2017/745 and EU IVDR 2017/746, manufacturers must undergo conformity assessment through a Notified Body. Choosing the right Notified Body is an important step, as review timelines, device scope, audit expectations, and technical expertise can vary significantly between organizations. Due to limited MDR and IVDR-designated Notified Bodies, manufacturers often face long review queues and should begin discussions early in the project.

Key selection factors include the Notified Body’s designation scope, experience with similar device types, review timelines, language preferences, and audit approach. Commonly used Notified Bodies include BSI Group, TÜV SÜD, TÜV Rheinland, SGS, Intertek, and DEKRA. Once selected, the manufacturer submits the Technical Documentation, QMS evidence, and application package for review, followed by documentation assessment and QMS audits.

Step 6 — Notified Body Review, Queries, and Conformity Assessment

After submission, the Notified Body begins a detailed review of the Technical Documentation and Quality Management System under EU MDR 2017/745 or EU IVDR 2017/746. This stage usually includes technical documentation assessment, QMS audits, and evaluation of clinical or performance evidence. It is common for Notified Bodies to issue queries or deficiency letters requesting additional clarification, supporting data, or document updates before approval.

The review phase is often the longest part of the CE Marking process and requires timely, well-structured responses to avoid delays. Clinical Evaluation Reports (CER), Performance Evaluation Reports (PER), PMS activities, and risk management documentation are typically reviewed in detail, especially for higher-risk devices. Experienced CE Marking consultants can help manufacturers manage Notified Body communication, respond to deficiencies effectively, and maintain alignment with current MDR and IVDR expectations.

Step 7 — EU Declaration of Conformity, CE Marking, and EUDAMED Registration

After successful conformity assessment, the Notified Body issues the CE Certificate for the device. The manufacturer must then prepare and sign the EU Declaration of Conformity (DoC), confirming compliance with EU MDR 2017/745 or EU IVDR 2017/746 requirements. Once completed, the CE Mark can be affixed to the device and its labeling.

Manufacturers must also complete EUDAMED registration, implement Unique Device Identification (UDI) requirements, and appoint an EU Authorized Representative if located outside the European Union. The EU Authorized Representative acts as the official regulatory contact within Europe and plays an important role in maintaining ongoing MDR or IVDR compliance.

Step 8 — Post-Market Surveillance and Ongoing Compliance

CE Marking under EU MDR 2017/745 and EU IVDR 2017/746 requires continuous post-market surveillance activities even after certification. Manufacturers must actively monitor device performance, collect real-world safety data, manage complaints, and maintain ongoing regulatory compliance throughout the product lifecycle.

Key post-market obligations include PMS reports, Periodic Safety Update Reports (PSUR), PMCF or PMPF activities, serious incident reporting, and Field Safety Corrective Actions (FSCA) where applicable. Notified Bodies regularly review these activities during surveillance audits, and failure to maintain an effective post-market system can lead to major nonconformities or certificate suspension.

MDR vs IVDR: Key Differences US Manufacturers Must Understand

For US manufacturers entering the European market, understanding the difference between EU MDR 2017/745 and EU IVDR 2017/746 is essential. The applicable regulation determines the conformity assessment pathway, clinical or performance evidence requirements, Notified Body involvement, and overall CE Marking strategy. Although MDR and IVDR follow a similar regulatory structure, they apply to different product categories and have distinct technical and documentation requirements.

MDR applies to medical devices such as implants, instruments, accessories, and Software as a Medical Device (SaMD) intended for diagnosis, treatment, monitoring, or prevention of disease. IVDR applies specifically to in vitro diagnostic products including reagents, test kits, calibrators, instruments, companion diagnostics, and diagnostic software used for examination of human specimens. Correctly identifying whether a product falls under MDR or IVDR is one of the first and most important steps in the CE Marking process.

Product Type	Applicable Regulation	Key Consideration
Blood glucose meter (hardware + software)	IVDR	Primary purpose is IVD examination
Clinical decision support software using IVD results	MDR	Software influences therapeutic decisions
Companion diagnostic for oncology drug	IVDR	Specifically listed as IVD under IVDR Article 2
Point-of-care infectious disease test	IVDR	In vitro examination of patient specimens
Wearable continuous glucose monitor	IVDR (sensor) + MDR (therapeutic component, if applicable)	Dual-regulation products require careful scoping
AI-based imaging analysis software	MDR	Influences diagnostic or treatment decisions
Laboratory automation instrument (non-diagnostic)	IVDR (if used with IVD reagents) or MDR	Intended purpose determines classification

When product scope is genuinely ambiguous, MDCG guidance documents — particularly MDCG 2019-11 on qualification and classification of software — provide the authoritative framework for determination.

Classification Rules — MDR Annex VIII vs IVDR Annex VIII

The classification systems under EU MDR 2017/745 and EU IVDR 2017/746 follow completely different regulatory approaches. Correct classification is critical because it determines the conformity assessment pathway, level of Notified Body involvement, and the amount of clinical or performance evidence required for CE Marking.

MDR Classification — Annex VIII

Under MDR, devices are classified into Class I, IIa, IIb, or III based on intended purpose, invasiveness, duration of contact, and whether the device is active or non-active. Important MDR considerations include software classification under Rule 11, higher classification for long-term use devices, and Class III classification for certain combination products containing medicinal substances. Many devices previously classified under MDD have also moved into higher-risk classes under MDR.

IVDR Classification — Annex VIII

Under IVDR, IVD devices are classified into Class A, B, C, or D based on patient risk and public health impact. Compared to the previous IVDD framework, IVDR significantly increases Notified Body involvement for most IVDs. Higher-risk products such as companion diagnostics, infectious disease assays, genetic tests, and self-testing devices often fall into Class C or D and require extensive performance evaluation and regulatory review.

Notified Body Requirements — MDR vs IVDR

Both MDR and IVDR require Notified Body involvement for higher-risk devices, but the specific requirements and additional steps differ between the two regulations.

Under MDR:

Under MDR:

Device Class	Notified Body Involvement
Class I (non-sterile, non-measuring, non-reusable surgical)	Self-certification — no Notified Body required
Class I sterile, measuring, or reusable surgical	Notified Body assessment of manufacturing/sterility aspects only
Class IIa	Notified Body assessment of Technical Documentation (sampling basis) + QMS audit
Class IIb	Full Notified Body assessment of Technical Documentation + QMS audit
Class III	Full Notified Body assessment + clinical evaluation scrutiny + QMS audit

For Class III devices, MDR also requires consultation with an Expert Panel for certain high-risk devices — a requirement with no equivalent under the legacy MDD that has added significant time and cost to Class III CE Marking projects.

Under IVDR:

Device Class	Notified Body Involvement
Class A (non-sterile)	Self-certification — no Notified Body required
Class A sterile	Notified Body assessment of sterility aspects only
Class B	Notified Body assessment of Technical Documentation + QMS audit
Class C	Full Notified Body assessment of Technical Documentation + QMS audit
Class D	Full Notified Body assessment + EU Reference Laboratory verification

The EU Reference Laboratory requirement for Class D IVDs is unique to IVDR and has no equivalent in MDR. For Class D devices such as HIV screening assays, blood group typing reagents, and NAT-based infectious disease tests, the Notified Body must consult a designated EU Reference Laboratory, which independently verifies the performance claims in the Technical Documentation. This adds a further 3–9 months to the conformity assessment timeline and requires the manufacturer to provide batch samples and full performance data directly to the reference laboratory.

Clinical Evidence Requirements — MDR vs IVDR

The clinical and performance evidence requirements under EU MDR 2017/745 and EU IVDR 2017/746 are significantly different because medical devices and IVDs are evaluated using different regulatory approaches. MDR focuses on clinical safety and performance of medical devices, while IVDR focuses on scientific validity and diagnostic performance of IVD devices.

MDR — Clinical Evaluation

Under MDR, manufacturers must perform a Clinical Evaluation and prepare a Clinical Evaluation Report (CER) demonstrating that the device achieves its intended purpose, the benefits outweigh the risks, and the device performs safely under normal conditions of use. Clinical evidence may include clinical investigations, literature data, PMCF data, and post-market experience. For Class III and implantable devices, Notified Bodies increasingly expect direct clinical investigation data rather than literature-only evaluations.

IVDR — Performance Evaluation

Under IVDR, manufacturers must conduct a Performance Evaluation and prepare a Performance Evaluation Report (PER). The PER includes scientific validity, analytical performance, and clinical performance data. Important elements include sensitivity, specificity, accuracy, precision, stability, and clinical association of the analyte with the target condition. Compared to FDA expectations, IVDR often requires more structured scientific validity documentation and broader performance evaluation evidence for IVD devices.

Frequently Asked Questions: CE Marking Consultants for MDR and IVDR

PROPHARMA

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Choosing the Right MDR and IVDR CE Marking Partner in 2026

PROPHARMA

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Post Market Surveillance and Post Market Clinical Follow Up Plan

ShareThoughts — Thu, 23 Jan 2025 06:25:50 +0000

A roadmap for Post market surveillance and Post market clinical follow-up plan updates

In the medical device industry maintaining high standards of product safety, efficiency and compliance is not only a legal obligation but a commitment to patient safety and innovation.

European Union Medical Device Regulation (EU MDR 2017/745) and ISO13485 emphasizes the importance of post-market surveillance (PMS), Post-market clinical follow-up (PMCF) and corrective and preventive action (CAPA) in ensuring safety and effectiveness of the device once they are marketed.

CAPA is a cornerstone in achieving this goal by addressing identified issues and mitigating potential risks. When integrated into PMS and PMCF systems, CAPA becomes an important tool for continuous product improvement and compliance.

CAPA according to Article 2(67) of EU MDR are the key components to continuous improvement to correct and eliminate the causes of noncompliance and to prevent a potential noncompliance from occurring. They should be comprehensive, outlining the actions identified to address the root causes and should describe any related preventive actions.

CAPA can be related to:

Devices already placed on the EU market.
Issues that might have a direct impact on the product and that might impact product safety, performance or quality and,
Any action related to a voluntary and non-temporary suspension of marketing of the device by the manufacturer which is not related to a commercial decision.
Evaluation of benefits and risks identified through post-market activities as described in Annex III, point 1 (a) of MDR, i.e. in particular:
Records referring to non-serious incidents and data on any undesirable side-effects.
Relevant specialist or technical literature, databases and/or registers.
Information, including feedback and complaints, provided by users, distributors and importers and,
Publicly available information about similar medical devices.

Role of CAPA in PMS and PMCF

The CAPA findings are central to the development of the PMS and PMCF. When issues are identified post market, CAPA procedure helps identify necessary corrective actions, which may result in updating the PMS or PMCF process. Here is how the CAPA findings suggest updating these plans:

Identification of emerging risks

CAPA investigations often uncover the root causes of emerging risks that were not identified or anticipated at the time of the pre-market stage or during the original PMS or PMCF process.

If device malfunctions or adverse events occur CAPA can identify the root cause, which could be design flaws, material defects, or manufacturing defects. Once it is detected then the PMS plan needs to be updated to track the identified risks.

Similarly, if CAPA reveals new clinical data related to device performance, the PMCF plan may need to be revised to include additional follow up studies, additional patient groups, or extended data collection assess the impact of these emerging risks.

Changing data collection strategies

CAPA investigations may reveal differences in the data collected during the initial PMS and PMCF activities.

CAPAs findings may reveal that medical device-related adverse events were inadequately captured in existing surveillance systems, perhaps due to inaccurate reporting, lack of knowledge, insufficient clinical follow up.

To address this, the PMS plan can be updated to incorporate more robust data collection methods, including expanding the sample size, increasing the frequency of reporting, or using alternative data sources such as registries or patient surveys.

For PMCF, CAPA findings may indicate that additional data points need to be collected to assess the long-term safety of the product, especially if issues arise that were not fully understood at earlier stages. Updates to the PMCF plan may include new clinical studies, longer follow-up periods, or specific post-market trials to monitor patients for additional risks that were not previously considered.

Enhancing risk management

A key component of CAPA is the identification and mitigation of risks. If CAPA findings provide a deeper understanding of device risk, this insight should be reflected in the risk management process.

For example, if CAPA findings identify potential safety risks not originally considered in the risk assessment, the risk assessment in the PMS process should be updated to reflect this new information.

In addition, the PMCF plan should be updated to include measures to mitigate or manage any identified risks. This may involve adding new clinical trials, modifying standards of care, or developing strategies to support patients. The risk management process must be proactive and responsive to CAPA findings, ensuring that the operation of the tool remains safe and effective over time.

A review of post-market performance indicators

CAPA findings can indicate the post market performance indicators (PMIs) identified in the PMS or PMCF plan are insufficient or inaccurate. If a specific performance indicator fails to identify a recurring problem or trend demonstrated in a CAPA investigation, these indicators may need to be reviewed.

The PMS system may need a more specific or flexible assessment process and to capture subtle changes in the product security profile.

For PMCF, this may mean changing clinical endpoints, expanding the clinical trial, or encouraging frequent assessments of patients using the device. Recalibrating PMIs based on CAPA findings can ensure both PMS and PMCF planning goes provides meaningful and practical information.

Stimulating corrective and preventive measures

The CAPA process is a corrective approach, with identified issues leading to corrective and preventive actions. If such actions are initiated, they may change the design, manufacture, or labelling of the product, which then requires updates to the PMS and PMCF systems. If a corrective action involves changing the materials used in a device, the updated PMS plan may need to include additional monitoring to assess the impact of the new materials on safety and performance. If corrections to be made involve resource consumption in the case of replacement of a device further monitoring may be required to assess the impact.

Similarly, if preventive measures require labelling changes to make users more aware of certain hazards, the PMCF system may need to expand its scope to determine whether new labelling leads to changes in patient outcomes or clinical practice. Both plans need to be modified to ensure that corrections and preventive measures are properly tested in the aftermarket phase.

Conclusion

CAPA findings play an important role in guiding updates to PMS and PMCF plans. Through its ability to identify emerging risks, gaps in data collection, and risk management deficiencies CAPA findings inform necessary changes to ensure that medical devices remain safe and effective over their lifecycle. By optimizing PMS and PMCF systems in response to CAPA findings, manufacturers can proactively address issues, improve device performance, and safeguard patient health. Continuous learning and adaptation through CAPA-driven updates to post-market strategies ensure medical devices remain compliant with regulatory standards and meet the highest standards of quality and safety.

References

· Tashi T, Mbuya VB, Gangadharappa HV. Corrective action and preventive actions and its importance in quality management system: A review. International Journal of Pharmaceutical Quality Assurance. 2016;7(1):1–6.

· MDCG 2022- 2021: guidance on periodic safety update report (PSUR) according to regulation (EU MDR) 2017/745.

· MDCG 2024–12 Corrective and preventive action (CAPA) plan assessment: guidance and templates for conformity assessment bodies, notified bodies, designating authorities and joint assessment teams

Dr. Shrinidhi Ballal, MDS

Jr. Consultant at i3cglobal

Clinical Evaluation and Labelling: How They Are Interlinked

ShareThoughts — Thu, 23 Jan 2025 06:22:14 +0000

How Clinical Evaluation and Labelling Work Together

Clinical evaluation and labelling form two integral components of the regulatory framework under the European Union Medical Device Regulation (MDR) 2017/745.

Though quite distinct, these two processes are intricately related and perform complementary functions for compliance with the requirements imposed by the GSPRs contained in Annex I of the MDR.

Multiple guidance documents issued by the Medical Device Coordination Group (MDCG) provide detailed insights into this interdependence:

MDCG 2020–13 emphasizes the importance of taking all necessary steps to ensure that medical devices are safe, effective, and compliant with regulatory requirements.
MDCG 2021–24 explains how data on safety and performance arising from clinical evaluation directly affect the labeling elements, including the IFU, warnings, and contraindications.
MDCG 2020–6 emphasizes that labeling should be based on clinical data, so that the label accurately reflects the intended purpose of the device, target population, safety, and performance.

Together, these guidances highlight the critical connection between clinical evaluation and labeling. Clinical evaluations provide evidence-based data that shape key labeling elements to ensure the following:

Compliance with GSPRs: Both clinical evaluation and labeling comply with the regulatory requirements set in MDR Annex I, thereby ensuring that the device is safe and performs well.
Minimized Risks: Evidence-based and fact-based labeling derived from clinical data helps minimize risks associated with the usage of a device by effectively communicating warnings, contraindications, and proper usage instructions.
Support for Intended Use: The intended purpose, target population, and usage instructions of the device are clearly articulated in the labeling, supported by robust clinical evaluation data.

The Interlink: How Clinical Evaluation and Labelling Work Together

The relationship between clinical evaluation and labeling is that both have, as a common goal, the safe use of medical devices in ensuring effective use.

Clinical evaluation provides evidence for the safety, performance, and use of a device, while labeling converts evidence into actionable, user-friendly information.

The interplay of these two processes ensures real-world application of the device in alignment with data generated when it was evaluated.

1. Feedback Loop for Continuous Improvement

Clinical evaluation and labelling form a dynamic feedback loop. Post-market clinical follow-up (PMCF) and vigilance activities continuously generate new clinical data, which may highlight emerging risks, novel use cases, or updates to the device’s performance profile.

This updated information feeds back into labelling, ensuring it remains current and reflects the latest clinical findings.

2. Customization for Stakeholders

The clinical evaluation supports the customization of labelling to meet the needs of diverse user groups, including healthcare professionals, lay users, and patients.

For instance, while healthcare professionals may require detailed scientific explanations, lay users benefit from simplified language and visual instructions. This tailored approach ensures that all users can understand and apply the device information effectively.

3. Mitigating Use Errors

The labelling process draws heavily on the outcomes of clinical evaluation to address potential use-related risks identified during clinical investigations or usability studies. By incorporating these insights, manufacturers can refine their Instructions for Use (IFU) and warnings to reduce errors, enhance user comprehension, and improve device handling across all intended settings.

4. Evidence-Based Marketing Claims

Clinical evaluation data not only confirm safety and performance but also serve as the basis for marketing claims. Elements of labelling, including promotional materials or brochures, must be in line with the evidence provided in the Clinical Evaluation Report (CER).

This will ensure that all claims are substantiated, avoiding misleading information and creating trust among users.

5. Facilitating Regulatory Compliance

Regulatory bodies assess the coherence between clinical evaluation and labelling as part of their conformity assessment process. Discrepancies between the two can result in regulatory delays or rejection.

The integration of clinical data into labelling ensures that both processes support each other in demonstrating compliance with the MDR, ultimately expediting approvals and market access.

This interdependency between clinical evaluation and labelling ensures that the device not only meets regulatory requirements but also delivers optimal performance and user satisfaction throughout its lifecycle.

By maintaining this synergy, manufacturers can achieve a balance between scientific rigor and practical usability.

Interlinking Factors:

· Risk Information: Clinical evaluation identifies risks associated with the device. These risks must be clearly outlined in the labeling, with corresponding instructions for risk mitigation.

· Indications for Use: The clinical evaluation helps define the intended use and patient population for the device. The labeling must accurately reflect this, detailing indications, patient criteria, and any restrictions.

· Performance and Safety Data: This would provide clinical data on how well the device functions and whether it is safe, critical for accurate labeling. All such new information-whether in post-market surveillance data or adverse event reports-may call for the updating of the labeling.

· Post-Market Surveillance: After a device is released into the market, post-market clinical evaluation through data can make changes in the labeling to include revised contraindications or updated usage instructions.

Conclusion

Synergies between the clinical evaluation and labeling assure the medical devices under the MDR 2017/745 are safe, perform appropriately, and maintain regulatory requirements.

Manufacturers, thereby, combine the integration of evidence-based data within user-centric labeling to gain regulatory compliance along with enhancing stakeholder’s trust and confidence.

Aligning for optimal device communication would be central to continuous progress in these areas: improvements in usability, risk reduction, and market acceptance. This interplay allows manufacturers to navigate the intricacies of regulatory frame works while providing the best possible medical devices with regard to safety and efficacy.

Author Name : Athira Unnikrishnan

Author designation: Junior Consultant (CER)

References

1. The EU MDR outlines the requirements for clinical evaluation and labelling. Key sections include:

2. MDCG 2020–13: Clinical Evaluation Assessment Report Template.

3. MDCG 2021–24: Guidance on Label and Instructions for Use.

4. MDCG 2020–6: Clinical Evidence Needed for Devices.

Clinical Evaluation Process For Combination Products

ShareThoughts — Thu, 23 Jan 2025 05:51:02 +0000

Navigating Clinical Evaluation Process for Combination Products!

Combination products are a niche class of medical devices whereby two or more regulated constituents, such as drugs and devices are combined to achieve a specific therapeutic purpose.

These products necessarily require careful consideration of pharmaceutical and medical device regulations that ensure compliance and demonstrate both safety, performance as well as clinical benefit.

This article details the step-by-step approach and considerations that guide the Clinical Evaluation Process in the context of combination products that fall under the EU’s Medical Device Regulation 2017/745.

What Are Combination Devices?

Combination devices are products that either:

1. Incorporate a medicinal substance as an integral part of the medical device, or

2. Combine a medicinal product with a medical device in a single product.

Article 117 of the EU MDR 2017/745 requires proof of conformity with GSPRs for single integral Drug-Device Combinations under the Marketing Authorization Application.

This provision, which was effective as of 26 May 2021, requires an opinion from a Notified Body to assure compliance with MDR. Despite limited guidance on dossier preparation for such products, the industry effort is aimed at establishing clarity and consistency in aligning with GSPR obligations.

Such efforts focus on addressing overlaps with medicinal product requirements and encouraging collaboration among stakeholders to streamline regulatory processes for Drug-Device Combinations (DDCs).

In the case of combination devices, the clinical evaluation should fulfill the relevant General Safety and Performance Requirements (GSPRs) as specified in Annex I of the EU MDR 2017/745. This includes safety, performance, and biocompatibility, among others, the compatibility and functionality of a drug-device combination.

Evidence to support these needs shall be included in the clinical evaluation section, using clinical data, risk assessments, and post-market surveillance data available for GSPRs.

The integration of medical devices with medicinal products has increased in marketing authorization applications, which reflects of the advancements in drug delivery technologies.

These Drug-Device Combinations can be categorized as integral or non-integral. Integral DDCs, as described in Articles 1(8) and 1(9) of MDR (EU) 2017/745, are products where the device and medicinal product form a single, non-reusable unit. Examples include pre-filled syringes, auto-injectors, drug-releasing implants, and intra-uterine devices, all designed for seamless administration.

Non-integral DDCs have separate components, such as nebulizers, reusable pens, oral dosing devices, or injection needles. Such devices are either co-packaged with the medicinal product or referenced in the product information and are obtained separately, requiring CE marking to meet regulatory standards.

With advanced devices, particularly with automated functions, DDCs improve patient convenience in easy self-administration or caregiver assistance for long-term outpatient care, thereby reducing the burden on healthcare systems.

An Example-Based Explanation: Prefilled Syringe (PFS)

A prefilled syringe (PFS) is a combination product comprising:

Syringe device: A delivery mechanism ensuring accurate administration of the drug.
Drug formulation: A therapeutic agent pre-filled into the syringe for intended use.

For the PFS Clinical Evaluation Report (CER), the clinical evaluation must particularly address relevant aspects:

1. Mechanical Safety and Performance: Functional integrity of the syringe, such as needle sharpness, plunger functionality, and accurate dose delivery.

Drug Stability and Compatibility: Chemical stability of the drug within the syringe material, supported by stability data and compatibility studies.
Combination-Specific Risks: Risks such as leachable from syringe components, potential interaction between the drug and syringe material, and needle stick injuries.

Steps in the Clinical Evaluation Process

Step 1: Understand Regulatory Requirements Combination products must address both:

Medical Device Regulations: Under MDR 2017/745, the CER is required to assess the safety, performance, and clinical benefits of the device component, according to Article 61, Annex I, and conformity assessment requirements under Annex IX or Annex X.
Pharmaceutical Regulations: The drug component of the drug-device combination must comply with Directive 2001/83/EC, demonstrating safety, efficacy, pharmacokinetics, pharmacodynamics, and potential interactions with the device.

Step 2: Define Scope and Objectives

The combination product’s intended purpose and each of the individual component parts along with their overall therapeutic benefit should be clearly defined. For instance, a drug-eluting stent combines the stent, which will restore blood flow, and a drug, preventing restenosis.

Step 3: Collect Relevant Data

Clinical Data:

Device Component: Data generated through clinical studies, preclinical testing, and PMS.
Drug Component: Pharmacological trials’ data
Combination Product: Research focused on the overall functioning of the combination product.

Preclinical Data: Such testing for biocompatibility, chemical stability, and material performance.
Post-Market Data: Adverse event reports, complaints and performance analysis regarding component as well as the combination.

Step 4: Perform a Systematic Literature Review Conduct a systematic review to identify:

Data demonstrating the safety and performance of the device.
Clinical data on the combination product or similar devices delivering the same drug.
Reports of adverse events or off-label use.

Step 5: Address Equivalence (if applicable) If claiming equivalence to an existing combination product, provide substantial evidence on:

Technical characteristics: Materials, design, and functionality.
Biological characteristics: Interaction with human tissues.
Clinical characteristics: Safety and performance outcomes.

Step 6: Conduct a Risk-Benefit Analysis Assess potential risks and side effects from the interaction of components. For instance, determine how the drug-release profile affects healing and whether material-drug interactions pose additional risks.

Step 7: Draft the CER Structure the CER to meet MDR requirements:

1. Executive Summary: Give an overview of the device’s safety, performance, and clinical benefit.

2. Product Description: Detail the combination product’s components, intended use, and therapeutic purpose.

3. Clinical Data Evaluation: Summarize literature, clinical trials, and PMS data.

4. Risk-Benefit Analysis: Describe the identified risks, mitigations, and overall benefits.

5. Conclusions: Confirm compliance with MDR and justify the product’s safety and efficacy.

Step 8: Submission and Review

Internal Review: Ensure the CER is in alignment with the Quality Management System.
Notified Body Submission: The CER is submitted as part of the Technical Documentation for MDR compliance.

Challenges and Best Practices

Key Challenges:

Data Integration: Combining clinical evidence for individual components and the combined product.
Regulatory Overlap: Navigating MDR requirements alongside pharmaceutical regulations.
Post-Market Surveillance: Ensuring long-term safety and efficacy monitoring.

Best Practices:

Adopt a structured CER development process.
Engage cross-disciplinary expertise, including clinical, regulatory, and technical specialists.
Maintain clear, comprehensive documentation to support regulatory submissions.

MEDDEV 2.1/3 Rev.3 Guidance

The MEDDEV 2.1/3 Rev.3 document provides specific guidance for borderline products and drug-device combinations. Key points include:

Determining the Primary Mode of Action (PMOA): Classify the product as a medical device or medicinal product based on its principal function.
Requirements for Devices with Medicinal Substances: Address the interplay between MDR and pharmaceutical regulations.
Regulatory Pathway Clarifications: Provide detailed instructions for compliance with EU regulatory frameworks.

Conclusion

Navigating the Clinical evaluation process for combination products requires a clear understanding of dual regulatory frameworks and a structured approach to integrating clinical and preclinical data for both the device and medicinal components.

By identifying the primary mode of action, addressing specific MDR requirements, and ensuring robust risk-benefit analysis, manufacturers can achieve regulatory compliance and deliver safe, effective combination products that manufacturers can ensure that combination products meet regulatory expectations and deliver optimal therapeutic outcomes meet patient needs.

A collaborative, well-documented strategy is key to overcoming challenges and optimizing outcomes in this complex process.

Author Name : Athira Unnikrishnan

Author designation: Junior Consultant (CER)

REFERENCES

EU MDR:European Union. (2017). Regulation (EU) 2017/745 on medical devices. Official Journal of the European Union.
MEDDEV2.1/3Rev.3:European Commission. (2015). Guidelines on the qualification and classification of borderline products, drug-device combination products.
Medical device combination products: what regulations should you apply before marketing them in the EU?
Guideline on the quality requirements for drug-device 5 combinations
Conformity with the relevant General Safety Performance Requirements listed in the European Medical Device Regulation 2017/745: Case study for a prefilled pen (prefilled syringe assembled with autoinjector parts forming a single integral product regulated as a medicinal product).

Demonstrating Equivalence Aspects

ShareThoughts — Thu, 23 Jan 2025 05:36:19 +0000

Understanding The Technical, Biological, And Clinical Aspects Of Demonstrating Equivalence

The MDR (Annex XIV, Part A) emphasizes the importance of considering technical, biological, and clinical characteristics when demonstrating equivalence to other devices.

The demonstration of equivalence must adhere to the requirements outlined in Part A, section 3 of Annex XIV of EU-MDR.

Annex XIV part A requires that the manufacturer should demonstrate that there are no clinically significant differences in safety or clinical performance with regard to technical, biological and clinical characteristics.

MEDDEV 2.7/1 Rev. 4 is a guidance document that provides guidance on clinical evaluation in the European Union. However, because it was published before MDR, it comes with some differences in this guidance and the regulations that has led to some confusion with respect to demonstrating equivalence.

MDCG 2020–5 explains these differences and also clarifies the prerequisites for determining equivalence in the EU. The document ends with some guidance on the identifying and utilizing clinical data.

PARAMETERS FOR DEMONSTRATING EQUIVALENCE IN THE EU

According to MDR and MEDDEV 2.7/1, manufacturers have to regard three characteristics while justifying device equivalency to their products: Technical, Biological and Clinical.

MDCG 2020–5 compares MEDDEV 2.7/1 Rev. 4 and MDR criteria for characteristics, explaining any significant differences and their significance for EU equivalence demonstration.

Technical:

As per MDR, Annex XIV Part A (3), it requires that technical characteristics shall be taken into consideration for the demonstration of equivalence, including that the device in question and the device presumed to be equivalent, the device should share similar design, usage conditions, physicochemical properties, deployment methods, principles of
operation, and critical performance requirements, with similar physicochemical properties, deployment methods, and critical performance requirements, including viscosity, energy intensity, surface characteristics, tensile strength, and software algorithms.

As per MEDDEV 2.7/1 Rev. 4, Appendix A1 requires that technical characteristics shall be taken into consideration for the demonstration of equivalence, including that the device in question and the device presumed to be equivalent are the device be of similar design, used under the same conditions of use, and have similar specifications and properties

(e.g., physicochemical properties similar to type and intensity of energy, viscosity, tensile strength, surface characteristics, wavelength, porosity, particle size, surface texture, specific mass, nanotechnology, atomic inclusions similar as nitrocarburising, oxidability), and use similar deployment methods (if relevant), and have analogous principles of operation and critical performance requirements Software equivalence.

In the section on technical characteristics, MDCG 2020–5 emphasizes that software equivalence is based on the functional principle of a software algorithm, clinical performance, and intended purpose, and it is not reasonable to demand equivalence for the software code

Similar vs. same technical characteristics of devices dictate that they should be used under similar conditions, while MEDDEV 2.7/1 Rev. 4 states they should be used under the same conditions. MDCG 2020–5 clarifies that similar conditions are only applicable if there is no clinically significant difference in safety and performance between the devices.

Biological:

As per MDR, Annex XIV Part A (3), it requires that biological characteristics shall be taken into consideration for the demonstration of equivalence; that is, the device uses the same materials or substances in contact with the same human tissues or body fluids for similar contact duration and release characteristics, including degradation products and leachable.

As per MEDDEV 2.7/1 Rev. 4, Appendix A1 requires the device should use the same materials or substances in contact with the same human tissues or the same type of body fluids.

Exceptions can be previsioned for devices that come in contact with intact skin and minor components of devices; in these cases, risk analysis results may allow the use of similar materials, taking into account the role and nature of the similar material.

Biological characteristic exceptions. MEDDEV 2.7/1 Revision creates exceptions for reviewing biological qualities using “similar” materials. MDCG 2020–5 clearly states that these exceptions to not using the same materials “are NOT acceptable under the MDR.”

~ The MDR makes a clear distinction between “same” and “similar” when defining these criteria, with “similar” denoting something that is similar but not identical and “same” denoting something that is identical.

A scientific rationale should support equivalency for each of these criteria, demonstrating that there are no clinically meaningful differences in the devices’ performance and safety for the target patient group.

~ If your device includes a difference with the equivalent device, or a modification (which could have been introduced to address a safety or performance issue of the equivalent device), a strong scientific justification should be provided to demonstrate that there is no impact on the clinical safety or performance of the device. Use the same materials “are NOT acceptable under the MDR.”

Clinical:

As per MDR,Annex XIV Part A (3) requires that both the medical device to be evaluated and the equivalent product must be used for the same clinical condition or purpose, including similar disease severity and stage.

It should be at the same site in the body, in a similar population, including in terms of age, anatomy, and physiology.

It has the same kind of user, and it has to perform similarly in terms of relevant critical performance in light of the anticipated clinical effect for a particular intended purpose, according to MDR, Annex 14.

As per MEDDEV 2.7/1 Rev. 4, Appendix A1 requires that the medical device is to be evaluated, and the equivalent product must be used for the same clinical condition (including, when applicable, similar severity and stage of disease and the same medical indication), and both devices are to be used for the same intended purpose, at the same site in the body, and in a similar population

(this may relate to age, gender, anatomy, physiology, and possibly other aspects). It is not previsioned to deliver significantly different performances (in the relevant critical performances, such as the expected clinical effect, the specific intended purpose, the duration of use, etc.).

The MDR does not specify that the device must be used for the same medical indication, gender, or duration, but MDCG 2020–5 outlines that both devices must be used for the same clinical condition or purpose.

CONCLUSION

The Medical Device Regulation (MDR) mandates manufacturers to demonstrate equivalence in relation to other devices based on technical, biological and clinical characteristics. MDCG 2020–5 clarifies these differences and outlines prerequisites for determining equivalence in the EU.

Technical characteristics include similar design, use under similar conditions, specifications, and critical performance requirements. Biological characteristics involve using the same materials or substances in contact with human tissues or body fluids, with exceptions for devices in contact with intact skin.

The device must be used for the same clinical condition or purpose, with similar severity and stage of disease, at the same site in the body, in a similar population, with the same user, and have similar critical performance for the expected clinical effect. MDCG 2020–5 covers these requirements, ensuring both devices must be used for the same clinical condition or purpose.

AUTHOR

Dr Minu Lazar, BDS (Junior Consultant CER)

REFERENCE

1. MEDDEV 2.7/7 revision 4, clinical evaluation: a guide for manufactures and notified bodies under directives 93/42/EEC and 90/385/EE

2. MDCG 2020–5 Clinical Evaluation — Equivalence

3. EU MDR

4. Laura Court, MDCG 2020–5 Explained: How To Demonstrate Equivalency in the EU (2022)

5. Helen Quie, How to use the Equivalence Pathway under MDR

Successful Clinical Evaluation Report under MDR 2017/745

ShareThoughts — Thu, 23 Jan 2025 05:29:53 +0000

Key Components of a Successful Clinical Evaluation Report under MDR 2017/745

A Clinical Evaluation Report (CER) becomes an essential document in terms of safety and performance of the device to prove that a device is safe and performs as intended. These are the key components of a successful CER within the framework of MDR 2017/745.

Scope and Objectives

The first and foremost stage in the preparation of the Clinical evaluation report includes and emphasizes the clear definition of its respective scope and objectives. Aspects of this include defining the description of the device, of its intended purpose.

This must include risk classification of the device and any regulatory approvals the device has obtained under MDR 2017/745. It should serve to define articulation between the rationale and aims of clinical evaluation.

Device Description

A thorough description of the device is essential. This should provide information on its design, mechanism of action, and intended use.

Device descriptions should also identify the salient functions that differentiate it from existing products. A comprehensive understanding of the device helps in evaluating clinical performance and safety.

State of the Art

It is called the “state of the art” requirement to compare the device against what is currently regarded as the most appropriate practice in medicine. This involves describing relevant current standards, clinical guidelines, and medical practices concerning the device’s intended use. Thus, a standard against which the device performance will be measured is established.

Clinical Data Sources

A strong clinical evaluation report (CER) should incorporate pertinent clinical data from diverse sources: clinical investigation, literature reviews, and post-market clinical follow-up (PMCF).

Appraisal for relevance, quality, and clinical importance should be adopted for all sources of clinical evidence. This appraisal step guarantees that only high-quality data will support conclusions in the CER.

Clinical Evaluation Plan (CEP)

Clinical Evaluation Plan sets the procedural records for every clinical evaluation. It defines the intended use of the device, its applicable clinical data, and techniques of evaluating and analysing the data. The CEP provides a systematic approach through which clinical evaluation is transparent and reproducible.

Identification and Critical Appraisal of Clinical Data

At the heart of the CER is the identification, the collection, and the critical appraisal of relevant clinical data. This data can include pre-market clinical trials, PMCF studies, or published literature. The CER would have to assess the relevance and quality of the data by whether it supports the intended claims of the device.

The appraisal process itself involves the evaluation of clinical study design, methodology, and outcomes. The data are to be evaluated for validity, reliability, and applicability to the target patient population. The CER must also consider gaps in clinical evidence and possible ways to bridge these gaps.

Risk-Benefit Analysis

The clinical evaluation report should consider the degree of adverse events, complications, and safety hazards linked with the device and compare these with anticipated clinical benefits. It is crucial to integrate data collected throughout the device lifecycle through post-market surveillance.

It is important to incorporate data collected during the lifecycle of the device via Post-Market Surveillance (PMS). As part of PMS, data is used for the continual evaluation of the performance and safety of the device.

It comprises reports from users, information on adverse events, and any newly available clinical evidence. The CER remains up to date by periodically updating it with PMS data.

Post-Market Surveillance and Clinical Follow-Up

The MDR 2017/745 gave specific emphasis on Post market surveillance and post-market clinical follow-up as continuous monitoring safety and performance of medical devices.

The CER has to describe the post-market surveillance system and clinical follow-up activities to collect further evidence after the placing of the medical device. This should include plans for real-world clinical data collection and analysis, e.g. adverse event reporting, registries, and patient monitoring.

Conclusion

A Clinical Evaluation Report (CER) is crucial for manufacturers to ensure the safety and performance of their devices. Key components of a successful CER include defining the scope and objectives, giving a detailed description of the device, comparing it with current standards and providing all relevant clinical data from various sources.

The Clinical Evaluation Plan (CEP) is the set of procedural records set for every evaluation in order to make evaluation processes transparent and reproducible. Moreover, the knowledge of clinical areas, regulatory requirements, and clinical evaluation methods is crucial when it comes to expertise.

Post-Market Surveillance (PMS) for patient safety is important for feedback in the proper and ongoing solicitation of performance and safety data. It ensures that the CER is updated, frequently available, and accurate for all relevant stakeholders.

AUTHOR

Dr Minu Lazar, BDS (Junior Consultant CER)

REFERENCE

1. MEDDEV 2.7/7 revision 4, clinical evaluation: a guide for manufactures and notified bodies under directives 93/42/EEC and 90/385/EE

2. MDCG 2020–5 Clinical Evaluation — Equivalence

3. European Commission. (2017). Medical Device Regulation (MDR) 2017/745.

Clinical Evaluation of Reusable, Measuring & Sterile Class I Medical Devices

ShareThoughts — Sat, 11 Jan 2025 10:43:17 +0000

Clinical Evaluation of Reusable, Measuring & Sterile Class I Medical Devices

Class I medical devices under the EU MDR are considered low-risk devices. These medical devices are usually non-invasive and for transient use, such as hospital beds or bandages, or invasive tools used only transiently in body orifices, such as dental impression materials.

Class I medical devices can be active, such as examination lamps.

However, the MDCG 2021–24 Guidance on the classification of medical devices specifies three subclasses of Class I devices based on device-specific features, that do require assessment by a Notified Body.

Class I medical devices are subdivided:

Class Ir (Reusable Surgical Instruments): are instruments designed for multiple use after proper cleaning and sterilization procedures. A notified body must assess the device’s reuse, including cleaning, disinfection, sterilization, maintenance, functional testing, and related usage instructions.
Class Im (Devices with a measuring function): Any Class I device with a measuring function must provide accurate measurement results. A notified body is required to assess aspects relating to the metrological requirements. Examples include expansion thermometers and measuring cups
Class Is (Devices in sterile condition): These devices are sold and delivered in sterile condition. A notified body is required to assess the aspects relating to establishing, securing and maintaining the sterile condition. An Example would be sterile bandage or a sterile syringe.

Clinical Evaluation for Class I Medical devices

Manufacturers of Class I devices do not normally need to submit CERs to a notified body for assessment.

However, a Class I device is still subject to the MDR requirements to perform a Clinical Evaluation in that it must demonstrate conformity with the Annex I GSPRs, suitability for the intended purpose and an acceptable benefit-risk profile.

Therefore, a Clinical Evaluation Report is still required for Class I devices and should be written with a similar degree of care and skill to those required for higher-risk devices.

Furthermore, Class I devices that are supplied sterile (Class Is), or reusable (Class Ir) or measuring function (Class Im) will require the involvement of a notified body. Manufacturers of these types of devices should prepare CERs with notified body involvement on mind.

Clinical Evaluation of Class I Reusable Surgical Devices

The following information needs to be given importance in the clinical evaluation of reusable Surgical Class I devices:

~ Durability and Material Integrity: The clinical evaluation concerning reusable Class I devices covers material integrity and durability, so the device can withstand multiple cycles of sterilization, cleaning, and disinfection without compromising performance or structural integrity.

~ Sterilization Validation: A rigorous process for sterilization should maintain the sterility of the device during its use; hence, the clinical evaluation will also involve data on the process of sterilization validation, and the ability of the device to remain sterile after multipurpose.

During the clinical evaluation, these are coming under the preclinical data that was retrieved from the manufacturer.

~ Risk management: The clinical evaluation should incorporate risk management strategies to prevent device reuse, such as preventing infection vectors from improper cleaning or sterilization and ensuring wear and tear do not compromise the device’s function or safety

Clinical Evaluation of Class I Measuring Device

The following information needs to be given importance in the clinical evaluation of Class I measuring devices:

~ Accuracy Testing: The device must undergo clinical testing to ensure accurate measurements compared to established standards, demonstrating its ability to deliver precise and reliable measurements across various conditions, demonstrating its reliability.

During the clinical evaluation, this is captured from the preclinical performance test evaluation that was retrieved from the manufacturer.

~ Performance Consistency: It is essential that the device performs consistently over time. The device’s long-term stability and performance across various user groups and environments must be consistently assessed in clinical evaluations.

~ User Training and Usability: The clinical evaluation should evaluate the user interface and the effectiveness of user training for accurate use of measuring devices, ensuring ease of use for healthcare professionals and patients.

Clinical Evaluation of Class I Sterile Devices

The following information needs to be given importance in the clinical evaluation of Class I sterile devices:

~ Sterilization Validation: The clinical evaluation comprises documentation on the sterilization method utilized, such as autoclaving, radiation, or gas sterilization that complies with international sterilization standards, which is effective in eliminating microorganisms.

~ Packaging Integrity: Packaging of sterile devices becomes an important factor in maintaining sterility, and clinical evaluations should also encompass tests concerning materials and design that provide maximum protection of the device against contamination.

~ Infection Control: Clinical data should show the device’s safety record, including infection rates, adverse events, and complications, indicating its intended use does not cause infections or complications.

Shelf Life: Testing long-term stability where the device’s performance and functionality are checked after regular intervals up to its shelf life. These are generally done by storing the device under conditions specified like ambient temperature and humidity for extended periods.

POST-MARKET SURVEILLANCE

Manufacturers of Class I devices need to EU MDR article 83 to perform PMS activity. This involves creating a detailed plan and reporting the results. The report should be updated whenever necessary and must be readily available to provide to the competent authorities upon request.

CONCLUSION

The Class I medical devices according to the EU MDR have a low level of risk devices, but they still require an evaluation by a Notified Body. Class I devices have three subclasses: Class I Reusable Surgical Devices, Class I measuring Devices, and Class I sterile Devices.

Continuous revision of a Clinical Evaluation Report (CER) is very important because it pursues constant demonstrating of safety and performance through clinical evidence during the whole life of a device.

Manufacturers must also plan, establish, document, implement, maintain, and update a post-market surveillance system proportionate to the risk class and appropriate for the device type

Author

Dr Minu Lazar, BDS (Junior Consultant CER)

REFERENCE

1. (EU) 2017/745 (MDR)

2. MEDDEV 2.7/7 revision 4, clinical evaluation: a guide for manufactures and notified bodies under directives 93/42/EEC and 90/385/EE

3. Ethen Drower, Breaking Down EU MDR Implementation for Class 1 Medical Devices

4. EUMDR-2023

5. “Clinical Evaluation of Medical Devices: A Practical Guide” by Joseph A. Buckley

6. “Post-market Surveillance of Medical Devices: A Global Overview” by Peter L. H. Lee

Components of a PMCF Plan

ShareThoughts — Tue, 07 Jan 2025 10:35:09 +0000

Key Components of a PMCF Plan

According to the European Union Medical Devices Regulation (EU) 2017/745, every manufacturer of medical devices must carry out periodic post-market clinical follow-up (PMCF) evaluations and collect and submit well-structured post-market surveillance reports regularly. It is a proactive process that collects and evaluates clinical data on the safety and performance of a medical device in normal use. According to the MDR Annex XIV Part B, PMCF should run continuously throughout the entire lifetime of a device.

A PMCF Plan is required by the European Union Medical Device Regulation (MDR 2017/745) for Class IIa, IIb, and III medical devices. The primary goal is to confirm the safety, performance, and clinical benefits associated with these devices throughout their lifecycle. Identify and even mitigate possible risks, lead to regulatory compliance, and protect patient health.

As part of post-market requirements, the PMCF Plan lets manufacturers monitor the real-time performance of their product and detect possible negative events not reported during pre-marketing clinical trials. Most importantly, such an event is significant in the case of those new devices that did not have considerable real-world use prior to market approval.

This article talks about the important key components of a PMCF plan, its significance in the regulation of medical devices, and how PMCF really plays its role in making sure that medical devices are still safe as time goes by.

General Methods and Procedures

This is the section which presents the overall strategy and methodologies for gathering clinical data by collecting user feedback, literature searches, and analysis of clinical data already in hand. The scope of this data is defined in order to glean useful insights into the performance and safety of the device.

Specific Methods and Activities:

In this instance, the plan provides exact acts and methods for collecting data. This may include clinical studies, surveys, registries, or any other possible means for collecting real-world evidence such as registry- or enrolment-based studies. Each method should be tailored to suit the specific needs of the device in question. Detailed and sound study design is the critical component of a PMCF plan. That pertains to whether the follow-up will include observational studies, randomized controlled trials, or registry-based research. The study design should be determined based on the kind of device, its potential risk, and the kind of clinical data necessary.

The rationale for Methods:

This section would be geared towards the justification of all the methods and activities. It would lay down the reasons why those methods are quite suitable for the device and how these methods would address post-market clinical follow-up requirements. Therefore, the rationale has to be based on scientific and clinical evidence. The methodology will be used to develop data collection frameworks and methods of individuals who will conduct actual analysis of such data. It involves also determining whether there will be a necessity to add other clinical trials or issues on data collection to meet the regulatory expectations. The methodology has to ensure that a robust design for the study withstands both orientations to meet the PMCF plan objectives.

Link to Clinical Evaluation Report (CER):

The PMCF Plan should relate to the relevant segments of the Clinical Evaluation Report (CER). These cover annotation of all clinically gathered data on the PMCF system and its analysis of results. Such approaches ensure that there is a connection between pre-market and post-market information. Analysis of such data would involve trend analysis, comparisons with premarket clinical studies, and the determination of newly emerging adverse events or risks. The manufacturer’s systems must allow continuous evaluation of such data for incorporation into decision-making.

Risk Management Integration

Involves the analysis of clinical data about comparable or similar devices already placed on the market. Performance and safety metrics are being compared so that manufacturers are aware of any risks and may undertake corrective measures. The PMCF plan would need to be integrated with the risk management system in which the device is already situated. A component of this is monitoring and mitigating risks from the time of market launch for that device. The new evidence derived from clinical follow-up activities is integrated into the risk management framework.

They shall evaluate all new risks identified as they are introduced through PMCF to determine the need for further action. This might take the form of changing the label on the device, putting out new warnings, or perhaps corrective action such as a recall of that device or modification.

Estimated Timeline and Milestones:

A timeline should underlie scheduled post-market clinical follow-up activity, as a PMCF plan should leave a clear timeline for collection, analysis, and reporting of the data particularly for how clinical findings are reported, at which time progress updates are submitted to regulatory authorities, and how modifications to the plan will be made where necessary by using such findings. Reassessment of the clinical performance of the device could take place at regular intervals, and the timeline should accommodate adaptations in the event of new safety issues.

Data Analysis and Interpretation:

The data collected will be reviewed and interpreted thoroughly. Such analysis could include statistical analysis, description of trends, and assessment of risks. This study will produce results that can be used to inform modifications to the device or its application.

Documentation

Proper documentation and reporting are essential aspects of Proper documentation and reporting are key parts of PMCF Plan. Keeping updated records from PMCF activities, gathered data, and analyses is also required. Routine reports must also be submitted to regulatory bodies on the findings and actions.

Reporting and Corrective Actions

A vital part of the PMCF plan is a strategy for reporting adverse events or any issue that has been discovered during a clinical follow-up. The manufacturer should define the processes for timely reporting to the applicable regulatory bodies.

In addition, if there were any adverse trends or safety issues, corrective actions might be applicable. Such action may comprise safety alert issuance; reconsideration of product labeling; modification in the device; or even recall of the device.

CONCLUSION

A Post-Market Clinical Follow-up (PMCF) Plan is a vital element in ensuring the safety, performance, and continued compliance of performance, and continued compliance of medical devices after they reach the market. The main elements of a PMCF plan-including establishing clear objectives, study design, identification and management of risk, data collection, and reporting-offer a structured and systematic method for post-marketing surveillance, assuring not only that medical devices meet requirements, but that time will cause them to perform their intended functions safely and effectively. For manufacturers, effective, secure PMCF Plans are an investment in the continued success and reliability of their medical devices in the longer term.

Author: Dr Minu Lazar, BDS, CER Exper and Writer

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ISO 13485 Certification in Saudi Arabia

ShareThoughts — Thu, 12 Dec 2024 10:18:13 +0000

ISO 13485 Certification in Saudi Arabia

At present, the healthcare industry in Saudi Arabia is quickly developing. While the global demand for reliable medical supplies grows significantly, it is critical to establish the medical devices’ safety and effectiveness. This is where ISO 13485 certification in Saudi Arabia can come into the picture and offer a standard model for the organizations that get engaged in designing, developing, manufacturing, installing, and even supplying medical instruments.

Hence the need to ascertain the quality and safety of health care devices in the modern international market. As for those companies that would look to wander into this market, the essential entryway to this market is getting the ISO 13485 certification. Still, let’s get specific: what exactly is ISO 13485 certification, and why is it so important for Saudi Arabian companies? Let’s take a closer look at the ISO 13485 certification’s primary objectives, requirements in Saudi Arabia, and how to get it.

Comprehending the ISO 13485 Certification in Saudi Arabia

The International Organization for Standardization (ISO) established ISO 13485, a well-recognized standard that addresses quality management systems (QMS) for medical devices.

They offer assistance organizations to meet client and regulatory desires and needs through the provision of great and secure medical devices. It also lays down a range of specifications aimed at being used to guarantee the standard design, production, implementation, and maintenance of medical devices that meet the laid-down requirements and are safe to use as intended.

Why ISO 13485 Certification in Saudi Arabia for Medical Device Entities?

The health regulatory body that exists in the KSA to regulate medical devices is the Saudi Food and Drug Authority (SFDA). Obtaining ISO 13485 in Saudi Arabia certification can serve as evidence of a business’s adherence to these guidelines. Here’s an overview of the reasons it matters.

Compliance with Controls: At the same time, did you know that more than 70% of nations in the world utilize the certification agreeing to the International Standard ISO 13485? Certification will demonstrate that your firm complies with the SFDA directions by opening pathways to showcase the use of your medical devices in Saudi Arabia.

Enhanced Patient Safety: Essentially, ISO 13485 involves the use of a risk management approach as its nucleus. This helps provide careful consideration for risk management that is related to the medical devices to put the protection of the patients first.

Increased Customer Confidence: Certification is vital in passing a message of quality and safety to society to the hospitals, clinics, and other health facilities relying on medical devices.

Competitive Advantage: Tragically, it isn’t simple to pick up a competitive edge in the exceedingly populated medical device market; be that as it may, ISO 13485 improves your commerce. It demonstrates that you are committed to conveying high-quality items and services and that you meet all the vital guidelines; this might give you a competitive advantage over other companies that have not gotten certification.

Operational Efficiency: It means that assimilation of the principles developed within the scope of the ISO 13485 standard will contribute to the enhancement of processes, the exclusion of failures, and the augmentation of general efficiency.

Processes Included in Getting ISO 13485 Certification in Saudi Arabia

The preparation for getting ISO 13485 certification in Saudi Arabia regularly includes the following steps:

Gap Analysis: A third-party certifier, such as I3CGlobal, certifying for ISO 13485 Certification in Saudi Arabia will assess the organization’s current QMS and decide the organizational gap.
Development and Implementation: To address the gap analysis findings, you will establish and put into practice a strategic QMS that meets the standard’s criteria. This could mean formulating documented procedures, carrying out risk analysis, and developing a system for corrective action.
Internal Audit: Internal audits imply the inspection of your organization’s QMS to determine if there are any non-conformities.
Management Review: The QMS is monitored and assessed, and where necessary, adjustments are made, suggesting situations that need to be constantly improved.
Certification Audit: Lastly, an accredited certification body will descend on your organization for assessment with a view to ensuring you meet the ISO 13485 standards. On successful completion, you will be issued the ISO 13485 accreditation.

How I3CGlobal can help you with ISO 13485 certification in Saudi Arabia

Although the process of attaining the ISO 13485 Certification in Saudi Arabia may appear to be a long and winding one, the process is actually quite manageable and even quite fulfilling, provided that one is correctly guided through the process. Here’s how I3CGlobal can be your trusted partner in achieving this critical accreditation.

Experienced Consultants: We employ qualified ISO 13485 consultants with over five years of experience working with medical device organizations on ISO 13485. They will be there to help you right from the time of choosing the right certification to pursue to the time of obtaining the same.
Streamlined Gap Analysis: First, we will assess your current QMS to determine all the gaps that exist within the system that need to conform to the ISO 13485 standards.
Improved Quality Management System: The standard establishes systematic ways of implementing quality control and thus enhances effectiveness in the operations, thus reducing errors, and in the end, the quality of products produced is standard.
Enhanced Risk Management: Thus, it is possible to state that conducting an appropriate risk management process helps a company minimize the risks related to medical devices.
Tailored Implementation Support: It is our pleasure to involve our consultants together with your staff to design and execute an efficient QMS that will suit the company requirements and correspond to the criteria of the ISO 13485 normative.

Conclusion

Obtaining an ISO 13485 certification in Saudi Arabia helps medical device manufacturers who intend to meet certain compliance and quality standards. In the current world of healthcare providers, getting a certification in ISO 13485 is not a mere choice but a necessity, particularly in Saudi Arabia. Not only does it help in the efficient obtaining of the necessary approvals from the authorities, but it also contributes to better positioning on the market, work effectiveness, and clients’ confidence. So, if your organization needs to gain and sustain such a valuable certification, it should follow the necessary requirements, pay attention to structural issues, and use I3CGlobal’s expertise. Get in touch with us today to learn more about this strategy and begin the process of attaining differentiation and superior quality in the Saudi Arabian market for medical devices.

Are you set for your organization’s ISO 13485 certification in Saudi Arabia? Begin your process now and guarantee that your medical devices are safe and of immaculate quality.

Update Clinical Evaluation Report

ShareThoughts — Tue, 12 Sep 2023 11:48:28 +0000

Update Your Clinical Evaluation Report

Clinical evaluation report is essential because it assures that, during the entire time a medical device is on the market, assessments of its performance and safety are supported by enough clinical data. For first-time CE-marking, a clinical evaluation report is required, and it needs to be actively updated.

For the duration of the device’s life cycle, the clinical evaluation and its documentation should be updated with clinical data from the post-market surveillance system (PMS) and post-market clinical follow-up (PMCF). The frequency of updates is determined by your device’s risk categorization and the PMS’s output.

Why Frequency of Updates in Clinical Evaluation Report

The manufacturer must specify and justify how frequently a clinical evaluation is required. The following are typical factors that the manufacturer should consider when doing this:

Whether the device carries any significant risks.
Whether the device is well-established while considering.
Innovation, alterations
Consider the information available from clinical investigations, PMCF studies, registries, or other systematic studies or the total number of devices currently in use on the market and anticipated vigilance system reporting rates.
Whether there are short-term, long-term, or intermediate-term hazards or uncertainties or any modifications to production processes or design.

The clinical evaluation report is update when the manufacturer obtains the latest information from PMS. If no such information is obtained, then a rationale should be given at least every year if the device carries major risks or is not yet well established or every two to five years if the device is not anticipated to cause significant hazards.

General Considerations on Updating the Clinical Evaluation Reports

Manufacturers are expected to set up and maintain a post market surveillance system that routinely tracks the clinical effectiveness and safety of the device. The clinical evaluation and the evaluation report must be routinely updated with post-market surveillance in compliance with the directives.

The Clinical evaluation consultants should confirm the following when revising the clinical evaluation:

Whether the benefit/risk profile, unfavorable side- and risk mitigation strategies are still,
compatible with a high degree of health and safety protection and acceptable based on current knowledge and the state of the art.
accurately addressed in the information materials and current PMS plan provided by the manufacturer.
Whether the already made claims and proposed new claims are justified.

If the manufacturer determines there is insufficient clinical data to certify compliance with the essential requirements, then the manufacturer will need to stop marketing the devices until conformity is restored and take the required corrective and preventative actions.

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Step 5 — Notified Body Selection and Submission

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