Medical Device Clinical Evaluation Report (CER)
EvySaif develops new CERs, updates existing ones, reworks legacy MDD evaluations, and remediates CERs after Notified Body findings, for medical device manufacturers under EU MDR. The work is clinician-led and covers the whole lifecycle: CEP, literature review, appraisal, benefit-risk analysis, and conclusions. Evaluations are conducted to EU MDR requirements and MDCG guidance, using the methodological principles of MEDDEV 2.7/1 Rev 4. We work with manufacturers in India, Europe, and MENA preparing for or maintaining CE marking, and with manufacturers reusing CE evidence for SFDA registration in Saudi Arabia.
If your product is an in vitro diagnostic, you need a Performance Evaluation Report under IVDR, not a CER. See our IVD performance evaluation service.
CER writing, review and remediation
New CER developmentA first CER for an MDR submission, written together with the CEP from the ground up.
CER updatesScheduled updates that bring in the PMS, PMCF, and literature results since the last version.
MDD to MDR transitionLegacy clinical evaluations reworked to MDR level ahead of the 31 December 2027 and 31 December 2028 deadlines.
CER review and gap assessmentAn independent check of a CER you already have, before the Notified Body sees it. You get a gap list: what holds, what can be justified, and what needs new data.
CER remediationResponses to Notified Body findings on an existing CER. The report is revised to close each finding, and the underlying problem is fixed so it does not come back at the next review.
Equivalence assessmentEvidence and justification for equivalence claims per MDCG 2020-5. Equivalence narrows the data you must generate; it does not remove the clinical evaluation requirement.
Clinical evaluation is a continuous process
Under MDR Article 61 and Annex XIV Part A, clinical evaluation is an ongoing process, required for all risk classes, even Class I. The MDR defines what must happen; MEDDEV 2.7/1 Rev 4, with MDCG documents such as 2020-6 and 2020-5, explains how, and Notified Bodies still benchmark against that methodology.
Scope and plan
A compliant evaluation starts with a Clinical Evaluation Plan (CEP), part of the technical documentation, which defines the scope, the state of the art, and the clinical evidence strategy.
Identify and appraise the data
Pertinent clinical data, both data generated by the device and data from an equivalent device, is identified and appraised for quality and relevance. The literature review must be systematic, following a pre-specified protocol with search terms and inclusion and exclusion criteria set before any results are reviewed.
Justify equivalence, or generate data
Where equivalence to another device is claimed, it must be justified against MDCG 2020-5. Where direct clinical data is needed and does not yet exist, a clinical investigation under ISO 14155 becomes necessary, and for implantable and Class III devices it is generally required.
Report, then keep it live
The analysis against the intended purpose is documented in the Clinical Evaluation Report, which connects forward to Post-Market Clinical Follow-up (PMCF) under Annex XIV Part B to keep the CER current over the device lifetime.
When a study is required: where existing data is insufficient to demonstrate conformity, and generally for implantable and Class III devices, a clinical investigation under ISO 14155 is needed. We design that protocol too.
What a CER contains
MEDDEV 2.7/1 Rev 4 gives a proposed table of contents for the CER in Appendix A9. Notified Bodies check submissions against it:
| Section | What it must establish |
|---|---|
| Summary | The device, the evidence base, and the conclusions, readable on its own |
| Scope of the evaluation | Device description, variants and accessories covered, intended purpose, claims, and the GSPRs that need clinical evidence |
| Background and state of the art | The medical condition, current treatment options and their outcomes, applicable standards and guidance, and the benchmark the device is judged against |
| Device under evaluation | Regulatory status, design features relevant to clinical performance, and any equivalence claim with its justification per MDCG 2020-5 |
| Identification of clinical data | The documented literature search protocol (databases, search strings, dates, inclusion and exclusion criteria) plus manufacturer-generated data: investigations, PMCF, complaints, and vigilance |
| Appraisal | Each dataset scored for suitability and contribution using pre-defined criteria, recorded in tables |
| Analysis | Whether the evidence demonstrates conformity with the relevant GSPRs, supports every claim in the IFU, and shows an acceptable benefit-risk profile against the state of the art |
| Conclusions | Which GSPRs are met by which evidence, residual risks, evidence gaps, and what PMCF will address |
| PMCF linkage | The open questions passed to the PMCF plan, with timelines for feeding results back |
| Evaluator qualifications | CVs and declarations of interest for the evaluators, showing the clinical and methodological expertise MEDDEV requires |
| References | Full citations for every source used, so each one can be retrieved |
The reviewer checks the report against the plan. Every GSPR the CEP flagged as needing clinical evidence must be answered in the conclusions. The literature search must match the protocol in the CEP, down to the databases and inclusion criteria. We prepare or update the CEP before writing the report. For the full method, see our guide to writing a CER under MEDDEV 2.7/1 Rev 4.
How clinical data is appraised: suitability, relevance, contribution
Each dataset is scored on two criteria:
SuitabilityDoes the data concern the actual device, or a properly justified equivalent? Was the device used for its intended purpose, in the relevant patient group? Is the report complete enough to assess? A study on a different indication or an off-label use scores low here. So does a conference poster without a methods section, even if its results are favorable.
ContributionHow much weight the data carries in the analysis. The type of source matters most: a randomized trial counts for more than a case series. The outcome measures, the length of follow-up, and the statistical and clinical significance of the results also count.
The criteria are defined in the CEP before appraisal starts. Each dataset's score is recorded in appraisal tables in the CER. Anyone reviewing the file can see why a study got the weight it did.
What we prepare
CEP and CERClinical Evaluation Plan and Clinical Evaluation Report to MDR Annex XIV.
Systematic literature workSearch protocols and literature review reports, reproducibly documented.
Equivalence justificationsAligned with MDCG 2020-5 where equivalence is claimed.
State of the art and benefit-riskState-of-the-art analysis and benefit-risk documentation.
Clinical development strategyFor higher-risk devices where new data is needed.
PMCF feeding the CERPMCF plans and reports that keep the CER current, plus Annex XIV gap analysis.
How the CER connects to the rest of your technical documentation
A CER is not a standalone document. The CEP defines the questions; the CER answers them and states which GSPRs are met by which evidence. The benefit-risk conclusion draws on the risk management file. PMS and PMCF results feed every update, and the gaps the CER identifies set the PMCF plan's agenda. For Class III and implantable devices, the SSCP summarizes the CER for the public.
Notified Bodies check these documents against each other. A claim that appears in the IFU but not in the CER becomes a finding. So does a risk file that disagrees with the benefit-risk conclusion. We write CERs with the whole file in view, and we prepare the connected documents too: technical documentation, post-market surveillance and PMCF, SSCP, and clinical investigation protocols.
What we need from you
A CER is built from your technical file. At kickoff we ask for:
Missing pieces are normal, especially for first MDR-cycle CERs. Part of our work is the gap analysis: what is missing, what can be justified, and what needs new data before submission. Gaps found at this stage can usually be closed with a justification, a PMCF commitment, or targeted new data. If the Notified Body finds them first, they become formal findings and delay certification.
How often a CER must be updated
Under the MDR, clinical evaluation continues for the life of the device, and the CER must be kept current. The MDR does not set fixed intervals; the manufacturer sets the interval and justifies it in the technical documentation. In practice, intervals follow MEDDEV 2.7/1 Rev 4 and Notified Body expectations:
At least annually for implantable devices, Class III devices, devices carrying significant risks, and devices that are new to the market or based on novel technology. For Class IIb and Class III devices this aligns with the annual PSUR cycle under Article 86. For implantables and Class III it also aligns with the SSCP update.
Every 2 to 5 years for well-established, lower-risk devices with a stable safety profile.
Immediately when something changes: a new safety signal from PMS or vigilance, a change to the intended purpose or claims, a design change with clinical impact, or a shift in the state of the art (a new competitor technology, a revised clinical guideline).
An out-of-date CER is a common finding. It is also the easiest one to spot: the report date is on the cover. We maintain CERs on a scheduled cycle, adding each year's PMS, PMCF, and literature results to the existing evaluation.
Who we support
How EvySaif helps
We prepare the full clinical evaluation, from the plan through the report, for devices of every risk class. Our literature reviews are systematic and reproducible, equivalence is justified to MDCG 2020-5, and the CER connects forward to the post-market obligations Notified Bodies expect to see joined up.
Why EvySaif
EvySaif ranks among the best research and medical writing consultancies in India. Every CER we write is evaluated by clinicians with documented, degree-level expertise in the relevant clinical field and in research methodology. That is the standard MEDDEV 2.7/1 Rev 4 sets for evaluators, and one of the first things a Notified Body checks. Our systematic-review experience comes from published academic work, and we apply the same discipline to CERs. The literature search is documented so it can be re-run. Every appraisal and weighting decision is recorded. The finished CER is consistent with the risk management file, the PMCF plan, and the SSCP, which reviewers check against each other.
Frequently asked questions
Yes. A clinical evaluation and CER are required for all risk classes under the MDR, including Class I devices, though the depth of evidence scales with risk.
Yes. Although it dates from the previous Directive, it remains the methodology Notified Bodies benchmark against, used together with MDR Annex XIV and relevant MDCG guidance.
When existing data is insufficient to demonstrate conformity, and generally for implantable and Class III devices. It is conducted under ISO 14155.
The Clinical Evaluation Plan comes first. It defines the device, its intended purpose, the GSPRs needing clinical evidence, the state of the art, and the methods for identifying and appraising data. The Clinical Evaluation Report documents the execution of that plan and its conclusions. Notified Bodies read them together and expect the report to follow the plan.
Each dataset is appraised on two criteria. Suitability: does it concern the actual or a justified equivalent device, used as intended, in the relevant population, with a complete enough report? Contribution: the type of data source, the outcome measures, the follow-up duration, and statistical and clinical significance. The criteria must be set before appraisal begins and applied the same way to every dataset. The scoring is recorded in the report.
At least annually for implantable, Class III, high-risk, or novel devices. Every 2 to 5 years for well-established lower-risk devices, with the interval justified. Any new safety signal, claim change, or shift in the state of the art triggers an update regardless of schedule.
Most findings are about how the evaluation was done. Common examples: the literature search cannot be repeated, appraisal scores were never recorded, a claim has no supporting evidence, or the PMCF plan does not cover the gaps identified in the conclusions. We take on this kind of remediation. The CER is revised to close each finding, and the underlying problem is fixed so it does not come back at the next review.
CDSCO does not ask for a document called a CER; that is an EU MDR requirement. But the clinical evidence a CER assembles is the same evidence CDSCO expects in the Device Master File. For the import route, CDSCO also relies heavily on your approvals and documentation from reference markets, including CE marking. A CER prepared for the EU therefore also supports an Indian registration. If India is your target market, see our CDSCO medical device registration service.
Cost depends on the device's risk class, how much literature and post-market data there is to appraise, whether equivalence is claimed, and whether this is a first CER or an update. A Class IIa device with a modest evidence base and a Class III device with an equivalence claim are very different projects, and the price reflects that. We give a fixed quote after a scoping call, and the quote holds unless the scope changes.
Not as it is. The MDR raised the evidence bar, and MDCG 2020-6 sets out what counts as sufficient clinical evidence for legacy devices. Old CERs often rely on equivalence claims and literature that no longer meet the MDR's definitions. Transition deadlines apply: 31 December 2027 for Class III and Class IIb implantable devices, 31 December 2028 for other devices covered by the extension. We rework legacy CERs to MDR level, keep what still holds, and rebuild the rest.
Our clinicians do. MEDDEV 2.7/1 Rev 4 expects evaluators with a relevant degree and documented experience, and their CVs and declarations of interest go into the report. Manufacturers without an in-house clinical team use us for exactly this.
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