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.

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.

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.

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.

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.

• 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

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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.

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.

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.

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:

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.

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