Medical Device Clinical Evaluation: CER and Clinical Evaluation Plan Under EU MDR

Clinical Evaluation Report Writing Services

Clinical evaluation report writing is more than summarising papers. A notified body expects a reproducible method, a clear link to the general safety and performance requirements (GSPR), and conclusions that match your labelling, risk management and post-market data. Our service covers each part:

• Clinical evaluation plan (CEP) written to Annex XIV Part A, Section 1(a).
• State of the art (SOTA) review of current treatment options, standards and benchmark devices.
• Literature search protocol and report with documented databases, search strings and selection criteria.
• Data appraisal and analysis using MEDDEV 2.7/1 Rev 4 suitability and contribution criteria.
• Equivalence assessment to MDCG 2020-5, covering technical, biological and clinical characteristics.
• Clinical evaluation report (CER) with benefit-risk conclusion and GSPR mapping.
• PMCF plan and PMCF evaluation report to MDCG 2020-7 and MDCG 2020-8.
• SSCP for implantable and Class III devices, where required by Article 32.
• Notified body response support: we answer deficiency findings and resubmit.

What Is Clinical Evaluation Under EU MDR?

EU MDR Article 2(44) defines clinical evaluation as a systematic and planned process to continuously generate, collect, analyse and assess the clinical data about a device. The goal is to verify the device's safety and performance, including its clinical benefits, when used as the manufacturer intends.

The output of this process is the clinical evaluation report. The CER documents the evidence, the method used to find it, and the conclusion that the benefit-risk ratio is acceptable. It is part of the technical documentation in Annex II and is reviewed by the notified body during conformity assessment. For Class I self-certified devices, the manufacturer must still hold a CER and present it to a competent authority on request.

Clinical evaluation is not a one-time task. Article 61(11) requires the evaluation and its documentation to be updated throughout the device lifecycle with data from post-market surveillance and PMCF.

Clinical evaluation is one part of the wider CE marking process, and the CER sits inside your MDR technical documentation.

MDR Article 61 and Annex XIV Requirements

Article 61 sets the legal requirements for clinical evaluation. Annex XIV Part A describes how to carry it out, and Part B covers post-market clinical follow-up. The key points are:

• Article 61(1): conformity with the relevant GSPR must be based on clinical data that provides sufficient clinical evidence. The manufacturer must specify and justify the level of evidence.
• Article 61(3): the evaluation must follow a defined, methodologically sound procedure based on literature, clinical investigation results and other available clinical data.
• Article 61(4): implantable and Class III devices need clinical investigations, unless an exemption in Articles 61(4) to 61(6) applies.
• Article 61(5): equivalence for implantable and Class III devices is only allowed when the manufacturers have a contract giving full access to the equivalent device's technical documentation.
• Article 61(10): where clinical data is not considered appropriate, conformity can be shown by non-clinical data alone, with adequate justification.
• Article 61(12): the clinical evaluation, its results and the clinical evidence are documented in the clinical evaluation report.

Annex XIV Part A requires a clinical evaluation plan, identification of relevant data, appraisal of each data set, generation of new data where gaps exist, and analysis of all data to reach a conclusion on safety, performance and benefit-risk.

Official sources: Regulation (EU) 2017/745 on EUR-Lex and the European Commission's MDCG guidance documents, including MDCG 2020-13 (clinical evaluation assessment report template), MDCG 2020-5 (equivalence) and MDCG 2020-6 (sufficient clinical evidence for legacy devices).

Clinical Evaluation Plan (CEP) Under MDR

The clinical evaluation plan is the first document a notified body checks. Under MDR the plan is mandatory, and a weak CEP is one of the most common reasons a CER fails review. Annex XIV Part A, Section 1(a) requires the plan to include:

1. The GSPR that need support from relevant clinical data.
2. The intended purpose of the device.
3. The intended target groups, with clear indications and contraindications.
4. The intended clinical benefits, with relevant and specified clinical outcome parameters.
5. The methods used to examine qualitative and quantitative aspects of clinical safety, with reference to residual risks and side effects.
6. An indicative list and specification of parameters used to determine the acceptability of the benefit-risk ratio, based on the state of the art.
7. How benefit-risk issues of specific components, such as pharmaceuticals or non-viable animal or human tissues, are addressed.
8. A clinical development plan, from exploratory investigations through confirmatory investigations to PMCF, with milestones and acceptance criteria.

We write the CEP so each objective has a measurable acceptance criterion taken from the state of the art. This makes the CER conclusion traceable: every claim in the plan is tested against data in the report.

MEDDEV 2.7/1 Rev 4 Clinical Evaluation Stages

MEDDEV 2.7/1 Rev 4 was written for the old Directives, but notified bodies still use its method as the practical framework for MDR clinical evaluation. It divides the work into five stages:

MEDDEV 2.7/1 Rev 4 Appraisal Criteria

Appendix A6 of MEDDEV 2.7/1 Rev 4 gives an example appraisal method that most notified bodies accept. Each data set is graded on two groups of criteria. Suitability criteria ask whether the data is relevant to your device. Contribution criteria ask how strongly the data supports your claims.

We apply these criteria to every included article and data set, and we record the weighting in an appraisal table attached to the CER. This lets the reviewer see why each source was given more or less weight in the final conclusion.

Literature Search for Clinical Evaluation

The literature search must be objective, documented and reproducible. If a notified body reviewer cannot repeat your search and get the same results, the CER will receive a finding. Our literature search process includes:

• Search protocol written before the search, with the PICO question (population, intervention, comparison, outcome).
• Databases such as PubMed/MEDLINE, Embase and the Cochrane Library, chosen to fit the device type.
• Search strings recorded exactly as run, with dates and number of hits.
• Inclusion and exclusion criteria applied in a documented two-step screening of titles, abstracts and full texts.
• Vigilance and safety databases such as FDA MAUDE, recall databases and competent authority safety notices.
• Clinical trial registries to find ongoing or unpublished studies.
• Literature search report with a PRISMA-style flow diagram showing how many records were found, screened and included.

We run separate searches for the device under evaluation (or its equivalent) and for the state of the art, because they answer different questions.

See our step-by-step literature search and review protocol.

State of the Art in the Clinical Evaluation Report

The state of the art describes what is currently accepted as good practice for treating or diagnosing the condition your device addresses. It is the benchmark against which the notified body judges your safety and performance results.

A good SOTA section covers the clinical background of the condition, current treatment options including non-device alternatives, relevant harmonised standards and common specifications, clinical guidelines from professional societies, and the performance and complication rates of similar devices on the market.

From the SOTA we set quantitative acceptance criteria, such as a target success rate or a maximum complication rate. These criteria go into the CEP and are tested in the CER. Without them, a reviewer has no way to judge whether your results are acceptable, and the benefit-risk conclusion is not supported.

Read more about state of the art (SOTA) analysis for medical devices.

Demonstrating Equivalence Under MDR

Many manufacturers use clinical data from an equivalent device to support their CER. MDR has made this route much stricter than it was under the Directives. Annex XIV Part A, Section 3 and MDCG 2020-5 require equivalence on three characteristics:

The manufacturer must also have enough access to the equivalent device's data to justify the claim. For implantable and Class III devices, Article 61(5) requires a contract with the other manufacturer that allows full ongoing access to its technical documentation. We assess whether equivalence is realistic for your device before writing, so you do not build a CER on a route that the notified body will reject.

For a detailed walk-through, read our guide to demonstrating equivalence across technical, biological and clinical characteristics.

Clinical Investigation or Literature Route?

Choosing the right source of clinical evidence is the most important decision in a clinical evaluation. There are three main routes:

• Literature and equivalence route: clinical data from published studies on your device or an equivalent device. Suitable for many well-established Class I, IIa and IIb devices.
• Clinical investigation route: new data from a study run under Annex XV and ISO 14155. Required for most implantable and Class III devices, and for novel devices with no equivalent.
• Combined route: literature and PMS data supported by a targeted clinical investigation or PMCF study to close specific gaps.

Article 61(6) exempts some devices from the clinical investigation requirement, such as sutures, staples, dental fillings, braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors, when the evaluation is based on sufficient clinical data and meets relevant common specifications. MDCG 2023-7 explains how these exemptions apply. We review your device class, novelty and existing data, and recommend the route with the least cost and risk that still meets the evidence level required.

Sufficient Clinical Evidence for MDR Clinical Evaluation

Article 61(1) asks the manufacturer to specify and justify the level of clinical evidence needed to show conformity with the GSPR. MDR does not give one number of patients or studies. The required level depends on the device characteristics, its risk class, its novelty, its intended purpose and the claims made by the manufacturer.

MDCG 2020-6 gives a hierarchy of clinical data, from high-quality clinical investigations and systematic reviews at the top, through registries and PMCF studies, down to complaint data, case reports and simulated-use testing. Higher-risk and novel devices need data from higher in this hierarchy. Well-established technologies can often rely more on literature, PMS and PMCF data.

We define sufficient clinical evidence for your device in the CEP, link it to each clinical claim, and show in the CER that the data meets that level. Where it does not, we document the gap and plan how PMCF will close it.

Clinical Evaluation for Different Device Types

The clinical evaluation approach changes with the type of device. Our clinical evaluation report writers have experience with:

• Medical device software: clinical association, technical performance and clinical performance, following MDCG 2020-1.
• Implantable devices: long-term safety data, clinical investigation planning and SSCP preparation.
• Combination products: devices with an ancillary medicinal substance, where the medicinal part is assessed alongside the device.
• Reusable surgical instruments: clinical data on reprocessing, durability and lifetime performance.
• Class I sterile and measuring devices: CERs focused on the sterile barrier or measuring function reviewed by the notified body.
• Legacy MDD devices: transition of existing CERs to MDR, using PMS data and MDCG 2020-6.
• Novel devices: devices with no equivalent on the market, where a clinical investigation strategy is needed early.

For each type we select the evidence route, SOTA benchmarks and PMCF activities that match how notified bodies review that kind of device.

Clinical Evaluation Report Structure

MEDDEV 2.7/1 Rev 4 Appendix A9 gives a model CER outline, and MDCG 2020-13 shows what notified bodies check in their clinical evaluation assessment report (CEAR). A typical MDR CER includes:

1. Summary of the evaluation and conclusions
2. Scope of the clinical evaluation
3. Device description, classification, intended purpose, indications and contraindications
4. Clinical background, current knowledge and state of the art
5. Device under evaluation: type of evaluation (equivalence or own data) and justification
6. Pre-clinical data summary, including bench, biocompatibility and usability data
7. Clinical data from the manufacturer: investigations, PMS, PMCF, complaints and vigilance
8. Clinical data from the literature, with search method and appraisal
9. Analysis of the clinical data: performance, safety and benefit-risk
10. Review of IFU, labelling and risk management for consistency
11. GSPR conformity table for the clinically relevant requirements
12. Conclusions, residual risks and data gaps to be addressed by PMCF
13. Date of next update
14. Evaluator qualifications, signatures and declarations of interest

You can see a full chapter-by-chapter outline in our clinical evaluation report sample.

PMCF and the Clinical Evaluation Report

Post-market clinical follow-up is the part of post-market surveillance that collects clinical data on a CE-marked device during normal use. Annex XIV Part B requires PMCF to confirm safety and performance over the device lifetime, find unknown side effects, monitor known side effects and contraindications, and confirm that the benefit-risk ratio stays acceptable.

The CER and PMCF are linked in both directions. Gaps found in the CER become objectives in the PMCF plan, and the PMCF evaluation report feeds new data back into the next CER update. If you decide PMCF is not needed, the CER must justify that decision.

We write the PMCF plan using the MDCG 2020-7 template and the PMCF evaluation report using MDCG 2020-8. PMCF activities may include user surveys, registry data, literature monitoring or a dedicated PMCF study, depending on the risks and gaps for your device.

Related reading: the components of a PMCF plan, and our PMS report and PSUR services.

How Often Should a CER Be Updated?

MDR requires the clinical evaluation to be updated throughout the lifecycle, and the manufacturer must justify the update frequency in the CEP. In practice, notified bodies expect the following:

An update is also needed when there is new safety information, a change to the device or its intended purpose, a new state of the art, or a notified body request. We offer CER update services so your clinical evaluation stays current between surveillance audits.

Our guide explains how and when to update a clinical evaluation report in more detail.

Clinical Evaluation Report Templates and SOPs

If your team prefers to write the clinical evaluation in-house, we provide ready-to-use MDR templates written by our clinical evaluation report writers. Each template follows Annex XIV, MEDDEV 2.7/1 Rev 4 and the current MDCG guidance, with instructions for each section.

To request a template, open the contact form, select Medical Device Clinical Evaluation and mention the template you need in your message.

Request a CER TemplateView CER Sample Outline

See also our clinical evaluation procedure (SOP) guide.

Common Notified Body Findings in CERs

Most deficiency findings on clinical evaluation reports come from a small set of repeated problems. We check for each of these before your file is submitted:

• No quantitative acceptance criteria for safety and performance, so the benefit-risk conclusion cannot be verified.
• State of the art section too short or not used to benchmark results.
• Equivalence claimed without enough technical, biological and clinical comparison, or without access to the other device's data.
• Literature search not reproducible, or search strings and dates missing.
• Clinical claims in the IFU and marketing material not supported by data in the CER.
• Inconsistencies between the CER, risk management file, IFU and PMS documents.
• Sufficient clinical evidence not defined or justified for the device.
• Data gaps identified but not carried into the PMCF plan.
• Evaluator CVs and declarations of interest missing or not meeting qualification requirements.
• Legacy MDD data used without the analysis expected by MDCG 2020-6.

If you have already received findings, we can review the notified body report, write the responses and update your CER.

Clinical Evaluation Report Writer Qualifications

MDR requires the clinical evaluation to be carried out by suitably qualified people. MEDDEV 2.7/1 Rev 4, Section 6.4 expects evaluators to have knowledge of research methodology, information management, regulatory requirements and medical writing, plus knowledge of the device technology and the relevant clinical field.

As a guide, the evaluator should have a higher education degree in a relevant field and five years of documented professional experience, or ten years of experience where a degree is not a prerequisite. Each evaluator signs a declaration of interest, and the CV is attached to the CER.

Our team includes medical writers, clinicians, biomedical engineers and regulatory specialists. Each CER is written by a qualified clinical evaluation report writer and reviewed by a second evaluator before release.

Why Choose Our Clinical Evaluation Report Consultants

Many in-house teams write a CER once every few years, while our clinical evaluation report consultants write and defend them every week. That experience shows in the details reviewers check first: acceptance criteria, reproducible searches, consistent claims and a clear benefit-risk argument. Choosing an experienced clinical evaluation report consultant reduces review rounds, protects your certification timeline and frees your regulatory team for other work.

Our Clinical Evaluation Process

1. Gap review: we review your existing technical file, claims, risk file and any previous CER.
2. Route decision: we confirm the clinical evidence route (own data, equivalence, investigation or combined).
3. Clinical evaluation plan: we write the CEP with objectives and acceptance criteria.
4. Literature search: we run and document the device and state of the art searches.
5. Appraisal and analysis: we grade every data set and analyse safety, performance and benefit-risk.
6. CER writing: we write the report, the GSPR table and the PMCF plan.
7. Internal review: a second evaluator checks consistency with your IFU, risk management and PMS.
8. Submission and response: we support the notified body review and answer findings.

Clinical Evaluation Report Cost

Our clinical evaluation report fees are fixed by device class and service tier. Prices are in US dollars per device or device family covered by one CER.

The final cost depends on the number of devices, the evidence route, the amount of existing data and whether a PMCF plan or SSCP is needed. Send us your device details for a fixed-price proposal.

Request a Fixed-Price Proposal

Clinical Evaluation Report FAQs

What is a clinical evaluation report?

A clinical evaluation report (CER) documents the clinical evaluation of a medical device. It presents the clinical data, the method used to identify and appraise it, and the conclusion on safety, performance and benefit-risk, as required by EU MDR Article 61(12).

Is a clinical evaluation report required for Class I devices?

Yes. All devices under EU MDR, including Class I, need a clinical evaluation and a CER as part of the technical documentation. For Class I self-certified devices, the notified body does not review it, but competent authorities can ask for it.

What is the difference between a CEP and a CER?

The clinical evaluation plan (CEP) defines what will be evaluated, how, and what results are acceptable. The clinical evaluation report (CER) documents what was found and whether the device meets the plan's acceptance criteria.

What must a clinical evaluation plan include under MDR?

Annex XIV Part A, Section 1(a) requires the relevant GSPR, intended purpose, target groups, indications and contraindications, clinical benefits with outcome parameters, safety methods, benefit-risk parameters, handling of specific components, and a clinical development plan.

Is MEDDEV 2.7/1 Rev 4 still valid under MDR?

MEDDEV 2.7/1 Rev 4 was written for the Directives and is not legally binding. It is still widely used by notified bodies as a methodology guide where it does not conflict with MDR and MDCG guidance.

What are the MEDDEV 2.7/1 Rev 4 appraisal criteria?

Appendix A6 grades data on suitability (device, application, patient group and report quality, coded D, A, P and R) and on contribution (data source type, outcome measures, follow-up, statistical significance and clinical significance).

How long does it take to write a CER?

A CER for a well-established device using the literature route typically takes 4 to 8 weeks once we have the required information. Class III, implantable or novel devices take longer because of the amount of data and analysis involved.

How much does a clinical evaluation report cost?

Our fees start at $2,999 for a Class I CER and go up to $14,999 for a Class III Assured package. See the fee table above for each class and tier.

Can I use an equivalent device for my CER?

Yes, if you can show technical, biological and clinical equivalence per Annex XIV and MDCG 2020-5, and you have enough access to the other device's data. For Class III and implantable devices, a contract granting full access is required.

When is a clinical investigation required under MDR?

Clinical investigations are required for implantable and Class III devices, unless an exemption in Article 61(4) to 61(6) applies. They may also be needed for any device where existing data is not enough to prove safety and performance.

Which devices are exempt from clinical investigations under Article 61(6)?

Article 61(6) lists devices such as sutures, staples, dental fillings, braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors, provided the evaluation is based on sufficient clinical data and meets relevant common specifications.

How often should a clinical evaluation report be updated?

Class III and implantable device CERs are usually updated at least annually. Lower-risk, well-established devices are often updated every 2 to 5 years. The frequency must be justified in the CEP and updated earlier if new safety data appears.

What is the state of the art in a CER?

It describes current accepted practice for the medical condition, including alternative treatments, standards, guidelines and the performance of similar devices. It is used to set acceptance criteria for your device.

Which databases are used for the literature search?

Common sources are PubMed/MEDLINE, Embase and the Cochrane Library, plus vigilance databases such as FDA MAUDE, recall databases and clinical trial registries. The choice depends on the device and must be justified.

What qualifications should a CER writer have?

MEDDEV 2.7/1 Rev 4 suggests a relevant degree plus five years of experience, or ten years of experience without a degree, with knowledge of research methods, regulations, medical writing, the device technology and the clinical field.

What is the link between the CER and PMCF?

Gaps and residual risks identified in the CER become PMCF objectives. The PMCF evaluation report then provides new data for the next CER update. If PMCF is not done, the CER must justify why.

Do you provide CER templates?

Yes. We provide MDR templates for the clinical evaluation report, clinical evaluation plan, clinical evaluation SOP and literature search protocol. Request them through our contact form.

Do I need a clinical evaluation SOP?

Yes. MDR Article 10 and Annex IX expect the quality management system to include a documented procedure for clinical evaluation, covering planning, conduct, updates, evaluator qualification and approval.

What is an SSCP and who needs one?

The summary of safety and clinical performance (SSCP) is required by Article 32 for implantable and Class III devices. It summarises the clinical evaluation for users and patients and is published on EUDAMED.

Can a CER be based only on non-clinical data?

Only in limited cases. Article 61(10) allows it where clinical data is not appropriate, with a justification based on risk management, the device-body interaction, clinical performance claims and the manufacturer's claims.

Can you update an MDD clinical evaluation report to MDR?

Yes. We review your MDD CER against MDR, Annex XIV and MDCG 2020-6 for legacy devices, close gaps in the plan, SOTA and data, and rewrite the report to MDR requirements.

Do you respond to notified body findings on the CER?

Yes. Notified body response support is part of our service. We review the findings, write the responses, update the CER and resubmit until the evaluation is accepted.

What do you need from us to start?

We need the device description, intended purpose, IFU and labelling, risk management file, any existing clinical or PMS data, and your previous CER if there is one. We send a full checklist after the proposal is accepted.

Do you work with manufacturers outside Europe?

Yes. We support manufacturers in India, the USA, the UK and worldwide seeking CE marking under EU MDR, with local offices in India, the USA and the UK.