MDR Clinical Evaluation Report (CER): Requirements, Evidence Gaps and PMCF

A Clinical Evaluation Report (CER) documents the results and conclusions of the clinical evaluation required under Regulation (EU) 2017/745 (MDR). Its purpose is not simply to summarise clinical literature. The CER must demonstrate, using sufficient and relevant clinical evidence, whether a medical device achieves its intended clinical performance and benefits while maintaining an acceptable benefit-risk profile.

Under MDR Article 61 and Annex XIV, clinical evaluation is a lifecycle process. The CER therefore needs to remain aligned with the device’s intended purpose, clinical claims, General Safety and Performance Requirements (GSPRs), risk-management documentation, state of the art, post-market surveillance (PMS) and Post-Market Clinical Follow-up (PMCF).

This creates an important practical question for manufacturers: what happens when the CER identifies an uncertainty or evidence gap?

The answer should not automatically be “run another study”. The evidence gap needs to be defined first, followed by the least burdensome evidence-generation method capable of resolving it.

This guide explains how the MDR, MEDDEV 2.7/1 Rev. 4 and key MDCG guidance fit together, how Notified Bodies assess clinical evaluation, and how CER findings should translate into proportionate PMCF activities.

Which MDR Clinical Evaluation Documents Apply?

Manufacturers often work with several regulatory and guidance documents simultaneously. They are related, but they do not serve the same purpose.

Document	Role in clinical evaluation
MDR Article 61 and Annex XIV	Legal basis for planning, conducting, documenting and maintaining the clinical evaluation and PMCF.
MEDDEV 2.7/1 Rev. 4	Legacy clinical-evaluation guidance developed under the former Medical Device Directives. It remains useful for several methodological aspects where consistent with the MDR.
MDCG 2020-5	Guidance on demonstrating equivalence under the MDR.
MDCG 2020-6	Guidance on sufficient clinical evidence for legacy devices previously CE marked under the MDD or AIMDD.
MDCG 2020-7	Guidance and template for the PMCF Plan.
MDCG 2020-8	Guidance and template for the PMCF Evaluation Report.
MDCG 2020-13	Clinical Evaluation Assessment Report (CEAR) template used by Notified Bodies when assessing clinical evaluation.
MDCG 2023-7	Guidance on exemptions from mandatory clinical investigations for implantable and Class III devices and access to data used for equivalence.
Commission Delegated Regulation (EU) 2026/1451	2026 amendment expanding the Article 61(6)(b) list of well-established implantable and Class III technologies exempted from the obligation to perform clinical investigations under specified conditions.

The documents should therefore not be treated as interchangeable CER templates. MDR Article 61 and Annex XIV remain the regulatory foundation, while the relevant MEDDEV and MDCG documents provide additional methodology or guidance for specific issues.

For manufacturers working across several MDCG documents, our MDCG guidance library provides further topic-specific guidance.

What Is an MDR Clinical Evaluation Report?

The CER is the documented output of the clinical evaluation.

MDR Annex XIV requires manufacturers to plan, continuously conduct and document clinical evaluation. The process includes:

1. defining the scope and requirements of the clinical evaluation;
2. identifying relevant clinical data;
3. appraising the suitability and quality of that data;
4. generating additional clinical data where required;
5. analysing the complete evidence base;
6. reaching conclusions regarding safety, clinical performance, clinical benefits and benefit-risk;
7. identifying unresolved clinical evidence gaps; and
8. updating the evaluation as new PMS and PMCF information becomes available.

Both favourable and unfavourable relevant data must be considered.

The CER therefore needs to show the reasoning that connects the available evidence with the manufacturer’s regulatory conclusions. A collection of literature summaries without a clear analysis of claims, risks, clinical benefits and remaining uncertainties is not sufficient.

CEP vs CER vs PMCF documentation

These documents are connected but have different functions.

Document	Main purpose
Clinical Evaluation Plan (CEP)	Defines how the clinical evaluation will be conducted, what evidence is required and how it will be identified, appraised and analysed.
Clinical Evaluation Report (CER)	Documents the evidence evaluated, the analysis performed and the resulting clinical and benefit-risk conclusions.
PMCF Plan	Defines how relevant post-market clinical data will be proactively collected and evaluated.
PMCF Evaluation Report	Documents and analyses the results generated through PMCF and feeds those conclusions back into the clinical evaluation.

For a detailed planning structure, see our Clinical Evaluation Plan template guide.

Core MDR Clinical Evaluation Report Requirements

There is no single universal CER table of contents prescribed by the MDR. The structure should allow the manufacturer and reviewer to follow the complete clinical argument for the device.

A defensible CER normally needs to address the following areas.

1. Device scope and intended purpose

Clearly define the device or device family covered by the evaluation, including relevant variants, accessories, software versions or configurations.

The intended purpose, indications, contraindications, target population, intended users and clinical benefits should remain consistent with the Instructions for Use, labelling, technical documentation and claims made for the device.

2. Clinical claims and applicable GSPRs

Identify the safety, performance and clinical-benefit claims that require clinical support.

The CER should make it possible to understand which evidence supports each material clinical claim and which applicable GSPRs depend on that evidence.

3. State of the art

The clinical evaluation should establish the current state of the art relevant to the intended purpose.

This may include:

• current clinical practice;
• alternative treatment or diagnostic options;
• relevant guidelines;
• comparable technologies;
• accepted safety and performance benchmarks;
• expected clinical outcomes; and
• known risks and complications.

State of the art is not static. Changes in clinical practice or available alternatives may alter the benchmark against which the device’s benefit-risk profile is assessed.

4. Identification of clinical data

Relevant evidence may come from several sources, including:

• clinical investigations of the device;
• published scientific literature;
• data concerning equivalent devices where equivalence is adequately demonstrated;
• PMS;
• PMCF;
• vigilance information;
• registries;
• complaints;
• real-world evidence; and
• other manufacturer-held clinical data.

The identification process should be systematic and reproducible enough to show that relevant unfavourable evidence has not been selectively excluded.

5. Critical appraisal of the evidence

Clinical data should be evaluated for relevance, methodological quality, scientific validity and applicability to the device and intended purpose.

The amount of evidence alone does not establish sufficiency. A large volume of poorly applicable evidence may contribute less to the clinical evaluation than a smaller set of directly relevant and methodologically robust data.

6. Clinical evidence analysis

The CER needs to integrate the evidence rather than describe individual sources in isolation.

The analysis should determine whether the evidence supports:

• clinical safety;
• clinical performance;
• intended clinical benefits;
• the manufacturer’s claims;
• the applicable GSPRs;
• identified residual risks;
• the current benefit-risk conclusion; and
• use of the device throughout its expected lifetime.

Contradictory or uncertain findings need to be addressed rather than omitted.

7. Remaining clinical evidence gaps

One of the most important outputs of the CER is the identification of questions the existing evidence cannot yet answer adequately.

These gaps may concern, for example:

• long-term safety;
• durability of clinical performance;
• specific patient subgroups;
• rare adverse events;
• residual risks;
• use in routine clinical practice;
• new or revised claims;
• device modifications;
• clinically relevant changes in state of the art; or
• uncertainties identified through PMS.

Those gaps should then inform the clinical development and PMCF strategy.

How MEDDEV 2.7/1 Rev. 4 Supports MDR Clinical Evaluation

MEDDEV 2.7/1 Rev. 4 was developed under the former Medical Device Directives rather than the MDR.

It should therefore not be presented as an MDR legal requirement. However, several of its methodological principles remain useful where they are compatible with Regulation (EU) 2017/745.

These include approaches to:

• defining the scope of clinical evaluation;
• identifying clinical data;
• scientific literature searching;
• appraising clinical evidence;
• analysing data;
• assessing equivalence; and
• documenting the clinical evaluation process.

Where MEDDEV and the MDR differ, the MDR takes precedence.

MEDDEV 2.7/1 Rev. 4 is not MEDDEV 2.7/4

This distinction is particularly important because the two documents address different topics.

MEDDEV 2.7/1 Rev. 4 concerns clinical evaluation.

MEDDEV 2.7/4 concerns clinical investigations.

For an MDR Clinical Evaluation Report, MEDDEV 2.7/1 Rev. 4 is therefore the relevant legacy clinical-evaluation guidance.

Equivalence Under MDCG 2020-5

When a manufacturer relies on clinical data from an equivalent device, equivalence needs to be demonstrated according to MDR Annex XIV and the principles clarified in MDCG 2020-5.

The assessment covers three groups of characteristics:

• technical characteristics;
• biological characteristics; and
• clinical characteristics.

Similarity in intended use or device category alone is not sufficient.

The manufacturer needs to assess whether differences between the devices could result in a clinically significant difference in safety or clinical performance.

Equivalence should therefore be treated as a structured evidence argument rather than simply a comparison table added to the CER.

For implantable and Class III devices, the requirements concerning access to data and the circumstances under which an exemption from a clinical investigation may apply need to be considered separately.

How MDCG 2020-6 Applies to Legacy Devices

MDCG 2020-6 focuses on devices previously CE marked under the MDD or AIMDD and provides guidance on determining whether their clinical evidence remains sufficient under the MDR.

A long history on the market does not automatically establish sufficient clinical evidence.

Manufacturers still need to consider factors such as:

• quality and quantity of available clinical evidence;
• relevance of historical clinical data;
• changes to the device or intended purpose;
• PMS and vigilance history;
• complaints;
• state-of-the-art developments;
• equivalence where relied upon;
• unresolved risks;
• previous clinical evidence gaps; and
• PMCF findings.

The required level of clinical evidence should be justified for the specific device rather than inferred solely from its history of use.

This is especially important during MDR transition, where older evidence generated under the Directives may remain useful but needs to be reassessed against the current intended purpose, clinical claims and MDR requirements.

When Is a Clinical Investigation Required?

For implantable and Class III devices, MDR Article 61(4) establishes the general requirement that clinical investigations shall be performed, subject to the exemption cases provided in Article 61(4) to (6).

MDCG 2023-7 provides additional guidance on how these exemption pathways operate and on the level of access to data required when equivalence is used.

For devices that are neither Class III nor implantable, the need for a clinical investigation depends on the objectives of the clinical evaluation and whether the available clinical evidence is sufficient to meet them.

Important 2026 update

Commission Delegated Regulation (EU) 2026/1451 expanded the Article 61(6)(b) list of implantable and Class III devices based on well-established technologies that may be exempt from the obligation to perform clinical investigations when the applicable conditions are fulfilled.

This does not remove the obligation to conduct and document a clinical evaluation.

A manufacturer relying on an exemption still needs sufficient clinical evidence to demonstrate conformity with the MDR.

Where the CER shows that existing evidence cannot adequately support a material safety, performance or clinical-benefit conclusion, additional evidence generation may still be required.

If a new clinical investigation becomes necessary, MDx CRO’s medical device clinical research services cover clinical strategy, study design, regulatory submissions, study execution and reporting.

How MDCG 2020-13 Should Be Used by Manufacturers

MDCG 2020-13 is sometimes incorrectly described as the manufacturer template for an MDR CER.

It is not.

MDCG 2020-13 provides the Clinical Evaluation Assessment Report (CEAR) template used by Notified Bodies when documenting their assessment of a manufacturer’s clinical evaluation.

That distinction matters.

A manufacturer is not required to reproduce the CEAR structure in its CER. However, the CEAR is useful as a review-readiness tool because it shows the areas a Notified Body assessor will examine.

These include:

• device description and intended purpose;
• clinical-evaluation planning;
• clinical claims;
• state of the art;
• clinical-data identification;
• appraisal methodology;
• equivalence where applicable;
• sufficiency of clinical evidence;
• benefit-risk conclusions;
• consistency with risk management;
• PMCF; and
• outstanding deficiencies or questions.

A useful internal exercise is therefore to review the CER against the CEAR questions before submission and confirm that the evidence and reasoning needed by the assessor can be located and followed.

For a closer examination of the document, see our guide to MDCG 2020-13 for medical device manufacturers.

From CER Evidence Gaps to a Proportionate PMCF Strategy

PMCF should not be approached as a standalone exercise disconnected from the clinical evaluation.

MDR Annex XIV defines PMCF as a continuous process that updates the clinical evaluation. PMCF should proactively collect and evaluate relevant clinical data in order to confirm safety and performance throughout the expected lifetime of the device, maintain an acceptable benefit-risk profile and identify emerging risks.

The starting point for a PMCF activity should therefore be the latest CER and its remaining uncertainties.

“When planning PMCF, the question should not be ‘What is the quickest survey we can distribute?’ but ‘Which remaining clinical uncertainty needs to be resolved, and what is the least burdensome method capable of generating the necessary evidence?’ The starting point should always be the latest Clinical Evaluation Report and the evidence gaps it has identified. Only once that clinical question is clear should the manufacturer decide whether the appropriate method is a survey, registry, observational study or another source of real-world evidence.”

André Moreira | Medical Devices Director at MDx CRO

Step 1: Translate the CER gap into a specific clinical question

A useful practical tool is a claim-risk-evidence matrix.

This is not a mandatory MDR template. It is a way to create traceability between the clinical evaluation and the evidence-generation activity that follows.

Element	Question to answer
Clinical claim or risk	What safety, performance or clinical-benefit conclusion are we trying to support?
Existing evidence	What evidence already supports that conclusion?
Residual uncertainty / CER gap	What remains uncertain after the current clinical evaluation?
Clinical question	What specific question must the new evidence answer?
Data required	What information is needed to answer the question credibly?
Decision supported	What regulatory or clinical decision will depend on the result?

For example:

Claim / risk	Existing evidence	CER gap	Question	Data required	Decision supported
Long-term clinical performance	Pre-market investigation plus early PMS data	Performance beyond the current follow-up period remains insufficiently characterised	Is clinical performance maintained over longer-term routine use?	Longitudinal outcome data with defined follow-up	Confirm existing claim, modify documentation or generate further evidence

The point is not to add another administrative table. The purpose is to prevent PMCF activities from collecting data that cannot actually resolve the uncertainty identified in the CER.

Step 2: Choose the evidence source that matches the clinical question

PMCF does not automatically mean launching a large prospective study.

Depending on the evidence gap, useful sources may include routine post-market data, focused surveys, existing registries or observational studies.

Evidence source	When it may be proportionate	Important limitation
Routine or real-world data	Complaints, vigilance data, service records, device telemetry or other existing systems can directly address the defined question.	Availability does not establish adequacy. Relevance, completeness, reliability and ability to answer the CER gap still need to be assessed.
Focused PMCF survey	Useful when the question concerns usability, reasons for discontinuation, off-label use, patient-reported outcomes or aspects of clinical performance that respondents can credibly report.	Survey questions must be traceable to predefined PMCF objectives. Recall, non-response and selection bias may materially affect conclusions.
Existing clinical or device registry	Appropriate where longitudinal population, exposure, follow-up and outcome data are needed.	Confirm that the registry captures the variables, population and outcomes required for the CER gap.
Prospective or retrospective observational study	Appropriate when eligibility, follow-up, exposure, outcome ascertainment or confounding needs to be controlled more rigorously.	Greater operational complexity should be justified by the clinical question.
More focused clinical investigation	May be necessary where the evidence gap cannot be credibly addressed through less intensive post-market methods.	Study design and regulatory pathway should be proportionate to the outstanding clinical question and device risk.

When a PMCF survey is appropriate

A survey should not contain general questions simply because they are easy to ask or likely to produce favourable responses.

Each question should contribute to a predefined PMCF objective and should be traceable to the CER evidence gap it is intended to address.

Where possible, subjective responses should be supported by objective information such as:

• medical records;
• diagnostic results;
• treatment records;
• device-generated data; or
• other source documentation.

This becomes particularly important when evaluating long-term outcomes, clinically relevant subgroups, durability or events that cannot be reliably assessed through respondent recollection alone.

A survey should also not be used to estimate an adverse-event rate unless there is a reliable exposure denominator and a credible method for evaluating non-response and selection bias.

The method must match the question.

When an existing registry is preferable

Where structured longitudinal evidence is required, an established clinical or device registry may provide a more efficient source than creating a proprietary registry.

A manufacturer should first determine whether an existing registry can provide:

• the required patient population;
• device identification;
• sufficient exposure information;
• relevant outcomes;
• appropriate follow-up;
• necessary confounding variables; and
• reliable data quality.

If those requirements can be met by adding a limited device-specific dataset to an existing registry, creating an entirely new registry may add complexity without improving the evidence.

When an observational study is more appropriate

A prospective or retrospective observational study becomes more useful when the manufacturer needs greater control over:

• eligibility criteria;
• exposure classification;
• clinical outcomes;
• follow-up periods;
• relevant confounding factors;
• missing data;
• subgroup analysis; or
• source-data verification.

The additional burden should be justified by the value of the evidence the study is expected to generate.

Keeping a PMCF Dataset Lean Without Weakening the Evidence

A lean PMCF dataset does not mean collecting as little information as possible.

It means collecting only the information necessary to answer the predefined clinical questions while retaining enough information to interpret the results properly.

Depending on the PMCF objective, the minimum dataset may need to include:

Device information

• device identification;
• hardware, software or algorithm version where applicable;
• indication and intended use.

Patient and use context

• relevant patient characteristics;
• use setting;
• relevant user profile;
• exposure or procedure denominator.

Clinical outcomes

• predefined safety endpoints;
• predefined performance endpoints;
• predefined clinical-benefit endpoints.

Variables needed to interpret the data

• relevant confounding factors;
• duration and status of follow-up;
• reasons for discontinuation or loss to follow-up;
• reasons for missing data.

Where feasible, PMCF records may also be linked with relevant complaints, serious incidents, service events, corrective actions, explants, device-generated data or medical records.

Controlled terminology, validation rules, plausibility checks, automated reminders and direct capture from existing systems may improve data quality more effectively than adding more questionnaire fields.

Before implementation, surveys and data-collection forms should also be tested with representative users to confirm that the questions are understandable and capable of producing interpretable responses.

Define the PMCF Protocol Before Collecting Data

The statistical and methodological approach should be defined before data collection begins.

Depending on the activity, the protocol should address:

• the specific CER evidence gap being investigated;
• predefined objectives and endpoints;
• target population;
• inclusion and exclusion criteria where applicable;
• sample-size rationale;
• expected response rate;
• expected attrition;
• missing-data assumptions;
• potential confounding;
• selection bias;
• subgroup analyses;
• follow-up period;
• data-quality controls; and
• predefined thresholds for escalation or additional investigation.

The sample-size rationale should relate to the purpose of the activity. Depending on the question, it may be based on precision, detection of an event or a predefined statistical hypothesis.

The protocol should also show how the activity fits within the broader PMCF Plan and previous or ongoing PMCF activities.

This traceability helps demonstrate that the activity forms part of a structured clinical-evidence strategy rather than an isolated data-collection exercise initiated only after a Notified Body question.

Can Interim PMCF Evidence Be Used During a Notified Body Review?

Where a Notified Body has identified an important clinical evidence deficiency or non-conformity, waiting until the final closure of a long PMCF activity may not always be the only way to demonstrate progress.

If planned prospectively, an interim report based on a predefined data cut may document:

• the approved protocol;
• recruitment or data-collection status;
• follow-up status;
• data collected to date;
• preliminary results;
• current data-quality limitations; and
• the plan and timeline for completing the activity.

Incomplete evidence should not be presented as a final clinical conclusion when the required sample size or follow-up has not been achieved.

However, a properly planned interim analysis may demonstrate that the manufacturer has implemented a credible evidence-generation activity and that data collection is progressing according to the protocol.

Where PMCF is being designed specifically to address a known Notified Body concern, discussing the proposed method, endpoints, population, follow-up and interim reporting strategy with the Notified Body as early as possible may help identify disagreement before significant resources are committed.

Such discussion does not guarantee acceptance of the final design or evidence.

Closing the Loop: How PMCF Results Feed Back Into the CER

The purpose of PMCF is not simply to produce a PMCF Evaluation Report.

The findings should be used to reassess the clinical conclusions that triggered the activity.

Document or process	How PMCF findings may affect it
Clinical Evaluation Report	Update clinical evidence, benefit-risk conclusions, claims and remaining evidence gaps.
PMCF Evaluation Report	Document the activity, results, limitations and conclusions.
Risk-management documentation	Reassess identified risks, emerging risks and effectiveness of risk-control measures.
PMS report or PSUR, as applicable	Integrate relevant post-market findings, trends and conclusions.
Labelling and IFU	Revise warnings, contraindications, claims or other information where supported by the evidence and required.
PMCF Plan	Continue, modify, reduce, expand or replace activities according to the remaining uncertainties.
Device or clinical-development strategy	Consider further evidence generation, design changes or corrective action when the findings justify escalation.

After each significant PMCF activity, the manufacturer should return to the original evidence gap and ask:

Has the uncertainty been closed, reduced or left unresolved?

If the objective has been achieved and the evidence is stable, the activity may be reduced, closed or replaced with proportionate ongoing monitoring when adequately justified.

If the evidence identifies a new safety, performance or clinical-benefit concern, further PMCF, a focused observational study, a clinical investigation or other corrective action may be required.

PMCF may also identify systematic misuse or off-label use. Our article on off-label medical device use under the EU MDR explains how these data can affect clinical evaluation and the device’s benefit-risk profile.

How Often Should an MDR CER Be Updated?

The MDR requires the clinical evaluation and its documentation to be updated throughout the device lifecycle using information generated through PMS and PMCF.

There is no single universal CER update interval that is appropriate for every medical device.

The update strategy should reflect factors including:

• device classification and risk;
• maturity of the technology;
• volume and quality of new clinical evidence;
• PMS and vigilance findings;
• PMCF results;
• new or modified clinical claims;
• changes to the device;
• new risks;
• changes in state of the art; and
• previous Notified Body findings.

For Class III and implantable devices, the MDR specifically requires the PMCF Evaluation Report, and where indicated the Summary of Safety and Clinical Performance, to be updated at least annually with the relevant data.

The CEP, CER, PMCF Plan, risk-management documentation and PMS outputs should remain aligned rather than being updated as independent documents.

Common MDR CER Problems

Clinical evaluation problems often arise from weak traceability rather than a complete absence of evidence.

Common issues include:

Treating the CER as a literature review

The CER should critically analyse the complete evidence base and reach device-specific clinical conclusions. Literature searching is one part of that process.

Using the wrong MEDDEV reference

MEDDEV 2.7/1 Rev. 4 addresses clinical evaluation. MEDDEV 2.7/4 addresses clinical investigations.

Claiming equivalence without demonstrating it

Similarity between devices does not automatically establish equivalence. Technical, biological and clinical characteristics need to be assessed under the MDR framework.

Treating MDCG 2020-13 as a manufacturer CER template

The document is the CEAR template used by Notified Bodies. Manufacturers can use it to understand the review perspective, but it does not replace the requirements of Article 61 and Annex XIV.

Failing to connect clinical claims with evidence

The reviewer should be able to understand which evidence supports each material clinical claim and benefit.

Leaving evidence gaps without an evidence-generation strategy

An identified gap should lead to a proportionate decision: additional analysis, PMCF, a registry, a survey, an observational study, a clinical investigation or another justified action.

Designing PMCF around the available method instead of the clinical question

A convenient survey is not automatically adequate evidence. The evidence source should be chosen because it can credibly answer the clinical question identified in the CER.

Allowing clinical documentation to become inconsistent

The CER should remain aligned with the CEP, intended purpose, IFU, risk-management file, PMS, PMCF, PSUR where applicable, SSCP where applicable and other relevant technical documentation.

MDR Clinical Evaluation Report Review Checklist

Before finalising or updating the CER, confirm that:

• The device and variants covered by the CER are clearly defined.
• The intended purpose is consistent across clinical and technical documentation.
• Intended clinical benefits and material claims are clearly identified.
• Applicable GSPRs requiring clinical evidence are addressed.
• The state of the art is current and relevant.
• Relevant favourable and unfavourable clinical data have been considered.
• Literature identification and appraisal methods are documented.
• Clinical investigations and manufacturer-held data are included where relevant.
• Equivalence is fully demonstrated where relied upon.
• PMS and PMCF information is integrated.
• Safety, clinical performance and clinical-benefit conclusions are explicit.
• Residual risks are consistent with the risk-management documentation.
• Benefit-risk conclusions are supported by the evidence.
• Remaining evidence gaps are explicitly identified.
• Each material gap is connected to an appropriate evidence-generation or monitoring strategy.
• PMCF objectives are traceable to unresolved clinical questions.
• New PMCF evidence has been fed back into the CER and related lifecycle documentation.
• Update triggers and responsibilities are defined.
• The CER is sufficiently clear for a reviewer to follow the reasoning from claim to evidence to conclusion.

Frequently Asked Questions

Need Support With a CER or Clinical Evidence Gap?

A strong Clinical Evaluation Report should do more than assemble evidence. It should make clear what the evidence demonstrates, where uncertainty remains and how the manufacturer intends to resolve that uncertainty.

MDx CRO supports medical device manufacturers with:

• Clinical Evaluation Plans and Clinical Evaluation Reports;
• systematic literature reviews and evidence appraisal;
• clinical evidence gap assessments;
• equivalence strategies;
• PMCF planning and study design;
• PMCF surveys, registries and observational evidence strategies;
• clinical investigation strategy;
• risk-benefit documentation;
• CER remediation following Notified Body findings; and
• MDR technical documentation.

If your CER has identified unresolved clinical evidence gaps, or a Notified Body has questioned the sufficiency of your evidence, explore our Regulatory Affairs and Technical Documentation services to discuss the most proportionate path forward.

Key Regulatory References

• Regulation (EU) 2017/745, Article 61 and Annex XIV
• Commission Delegated Regulation (EU) 2026/1451
• MEDDEV 2.7/1 Rev. 4
• MDCG 2020-5: Clinical Evaluation – Equivalence
• MDCG 2020-6: Sufficient Clinical Evidence for Legacy Devices
• MDCG 2020-7: PMCF Plan Template
• MDCG 2020-8: PMCF Evaluation Report Template
• MDCG 2020-13: Clinical Evaluation Assessment Report Template
• MDCG 2023-7: Exemptions from the Requirement to Perform Clinical Investigations