Your existing clinical evaluation report may contain years of useful work. The question is whether that work supports the device, intended purpose and clinical claims you now want assessed under MDR. A previous CE mark does not answer that question on its own.
This guide focuses on that clinical decision. It does not determine whether your device qualifies for the legacy transition period or replace a device-specific assessment of the applicable legal requirements.
What can you retain from a MEDDEV-based CER?
Moving from MEDDEV 2.7/1 revision 4 to MDR does not mean discarding every method or starting every search again from zero. It means separating reusable work from conclusions that need a fresh justification.
MDCG 2020-6 addresses sufficient clinical evidence for devices previously CE marked under the Directives. It recognises the relevance of existing pre-market and post-market data and identifies MEDDEV sections that remain useful. It also explains why historical certification alone does not establish sufficient evidence for MDR conformity.
MDCG and MEDDEV documents are guidance. The MDR supplies the legal requirements, including Article 61 and Annex XIV, so use the applicable legal text alongside the guidance.
Treat methodology, data and conclusions as three separate layers. A documented literature appraisal method may remain suitable, while its search period needs extending. A historical study may still matter, while its relevance to a changed device configuration needs reassessment. A benefit-risk conclusion may need revision even if the underlying study remains sound, because treatment alternatives or recognised risks have changed.
Use three decisions in your working register.
| Decision | What it means | What it does not mean |
|---|---|---|
| Retain | Keep an identifiable method or source after confirming its relevance and suitability | Carry forward the old conclusion without checking it |
| Reappraise | Reassess quality, relevance, contribution and limitations against the current clinical question | Add a sentence saying the evidence remains valid |
| Replace or supplement | Replace an unsupported argument or obtain the evidence needed to address a gap | Delete inconvenient evidence or hide an unresolved uncertainty |
Record the reason for each decision. Someone reading the new CER should be able to distinguish an unchanged source from a newly justified conclusion.
Define the clinical scope before refreshing the literature
A search cannot establish sufficiency until you know what the evidence needs to support. Start with the intended purpose, indications, patient population, intended users, use environment and device configurations in the proposed MDR scope.
Compare those details across the current instructions for use, clinical evaluation plan, CER and risk documentation. Include promotional claims in the comparison. An apparently modest statement such as suitability for children can create a different clinical question from the adult use addressed in the evidence.
Build a claim-to-evidence map before deciding which sections to rewrite. For each claim, identify the clinical benefit or performance being assessed, the relevant outcome, the population and the period of observation. Then identify the sources that actually address those elements. Avoid accepting a paper as relevant merely because it mentions the same device category.
For an illustrative reusable compression device, a study of short supervised use in adults would not automatically support extended unsupervised use in children. The mechanism may be similar, but the users, population and exposure differ. The clinical evaluator needs to assess those differences rather than treating a shared product name as a bridge.
This first pass also exposes claims that have entered the documentation without an explicit evidence decision. Resolve them before the literature review expands around an assumed scope. Narrowing a claim may be an option, but it requires controlled assessment of the intended purpose, labelling and related regulatory consequences. It is not simply a CER edit.
Make the MDR CER update a decision register
A useful migration register explains what survives, what changes and who must act. The following example is entirely illustrative. The device, document identifiers, gaps and proposed actions are invented to demonstrate the method, not drawn from a customer or a completed conformity assessment.
Assume an existing CER covers a reusable, non-implantable compression device. The proposed MDR documentation includes adult use and a broader population claim. The clinical owner has located the old search records, a comparator-based argument and historical surveillance summaries.
| Old CER item and source | Assessment basis | Decision and evidence limit | Required action | Linked records and owner |
|---|---|---|---|---|
| Literature method in CER revision 3, supported by search protocol LP-02 revision 1 | Systematic identification and appraisal of relevant data, as addressed in Annex XIV Part A and MDCG 2020-6 | Retain the documented approach if suitable, then reappraise its scope. The last search predates the current claims and recent literature | Check databases, terms and inclusion criteria against the current clinical questions. Update the search and preserve exclusion reasons and appraisal records | Clinical evaluation plan, search protocol and CER. Clinical evaluator owns the assessment |
| Equivalence conclusion in CER revision 3, based on comparator brochure CB-01 and published study CS-04 | Technical, biological and clinical comparison addressed in Annex XIV Part A and MDCG 2020-5 | Reappraise. Public material describes intended use but leaves relevant patient-contact material and operating characteristics unresolved | Identify the missing characteristics and assess access to supporting information. Do not use the comparator as an equivalent-device evidence source unless the argument can be substantiated | Equivalence assessment, CER and risk file. Clinical evaluator and engineering lead share the evidence task |
| Broad population claim in IFU revision 4, supported by adult-only study AS-02 | Evidence must address the intended purpose and relevant population | Replace the unsupported conclusion. The available study does not directly address the broader population | Assess whether other adequate evidence exists. If not, define an evidence-generation strategy or assess a narrower scope through change control | Intended-purpose statement, IFU, clinical evaluation plan, CER and risk file. Clinical and regulatory leads own the scope decision |
| Safety conclusion based on complaint summary PMS-03 revision 2 | Appraisal of post-market evidence and its limitations | Retain the underlying records, reappraise their contribution. Units sold do not establish patients exposed, treatment duration or reporting completeness | Reconcile complaint categories with known risks, assess exposure estimates and investigate relevant signals. State what the dataset cannot establish | PMS report or PSUR as applicable, CER, risk file and PMCF plan. PMS owner provides the dataset |
The register makes two distinctions visible. Retaining a source does not mean retaining every use made of it, and replacing an argument does not necessarily mean replacing the device or running a new investigation. The clinical question determines the next evidence step.
For each action, add a specific completion test. The equivalence row is not complete when someone uploads another brochure. It is complete when the evaluator can substantiate the relevant comparison and access requirements, or has revised the evidence strategy because that route remains unsupported.
Reappraise equivalence before relying on it
An old equivalence table is a starting point for review, not proof that the argument carries into MDR. Assess the technical, biological and clinical characteristics together, with attention to differences that could affect clinical safety or performance.
MDCG 2020-5 explains the MDR equivalence framework and the need for sufficient access to relevant data. A comparison based on similar intended use alone leaves the rest of the argument unanswered.
In the illustrative compression-device example, the comparator brochure might describe the same broad clinical purpose while omitting information needed to assess material contact or pressure delivery. That absence does not prove the devices differ. It means the current evidence cannot establish the comparison on that point. Record the uncertainty rather than filling the cell with an assumption.
Separate three questions in your assessment. Can you substantiate the relevant characteristics? Can you explain why identified differences do not create a clinically significant difference in safety or performance? Can you demonstrate the access to data required for the route you are relying on?
Do not turn the contract provisions associated with Article 61(5) into a universal requirement for every equivalence argument. That provision addresses a particular route involving implantable and class III devices and another manufacturer. Equally, do not treat public availability of some comparator information as proof that access is sufficient. Check the applicable route and its conditions for your device.
If the equivalence argument fails, the literature may still help describe the state of the art or inform risk analysis. Its contribution has changed. Keep that distinction explicit so background evidence does not quietly become direct support for your device claims.
Distinguish missing explanation from missing evidence
The most important output of the gap assessment is the type of gap, because each type requires different work. A document problem may need a clearer traceable explanation. A clinical evidence problem needs a decision about evidence or scope.
| What you find | What to investigate | A useful next action |
|---|---|---|
| A relevant study appears in the bibliography but not in the analysis | Whether the evaluator assessed its quality, relevance and contribution | Appraise the study and explain its effect on the conclusion |
| The CER concludes that risk is acceptable using an outdated treatment comparison | Whether current alternatives, outcomes or recognised risks change that conclusion | Refresh the state-of-the-art assessment and revisit benefit-risk reasoning |
| The claimed population has no adequate supporting evidence in the identified dataset | Whether suitable evidence exists elsewhere or must be generated | Define the evidence gap and evaluate evidence generation or a controlled scope change |
| The CER and PMS report describe the same adverse event differently | Whether the difference reflects terminology, dataset scope or a missed safety assessment | Reconcile the source records before changing either conclusion |
A high volume of papers does not resolve a mismatch between the evidence and the claim. Nor does long market experience automatically answer questions that the surveillance system never measured. Complaint data may help identify safety signals while offering little information about the magnitude of a clinical benefit.
Assess favourable and unfavourable evidence with the same discipline. If a new publication challenges the expected benefit, explain its relevance, limitations and effect on the overall evaluation. Excluding it because it complicates the conclusion defeats the purpose of the update.
A new clinical investigation is not the automatic answer to every legacy CER gap. Whether you need one depends on the applicable requirements, the device and the evidence already available. An exception from a particular investigation requirement is not an exception from demonstrating the required clinical evidence.
Keep PMCF tied to a defined clinical question
Post-market clinical follow-up, or PMCF, should address specific questions about the device in use and feed the clinical evaluation. It should not serve as a general promise to collect whatever evidence the current report lacks.
MDCG 2020-6 discusses the relationship between sufficient evidence for the first MDR assessment and continuing clinical evidence generation. Use that distinction when assessing a gap. Evidence needed to support the present conformity conclusion cannot simply move into a future PMCF activity because that is easier to schedule.
For the illustrative device, assume the assessment supports the adult indication but identifies a remaining question about performance over repeated treatment cycles. A targeted PMCF activity could address that question if the clinical evaluation justifies the current evidence position. The plan would need a relevant population, defined outcomes, follow-up, an analysis approach and a rationale for the method.
By contrast, a proposal to enrol adults after certification does not substantiate the unsupported broader population claim. The proposed activity does not even answer the missing question. The evaluator must first decide what evidence the broader claim needs and whether the current scope remains defensible.
For each PMCF question, write down how the result could change the CER, risk assessment or information supplied with the device. If the result could not affect any decision, reconsider whether the activity is collecting useful clinical information. Where you propose that a particular PMCF activity is unnecessary, document the device-specific rationale rather than relying on legacy status alone.
Finish with one coherent clinical position
The revised CER should leave no ambiguity about which claims the evidence supports, where limitations remain and how those limitations affect the conclusion. You should be able to follow each material conclusion back to appraised sources and forward to the documents that rely on it.
Before closing the update, compare the clinical evaluation plan with what the evaluation actually did. Reconcile the assessed populations and configurations with the IFU. Check that the risk documentation reflects the clinical findings and that the PMS and PMCF plans address the uncertainties identified in the evaluation. Where applicable, check consistency with the PSUR and summary of safety and clinical performance.
Return to the register and close each row with a reasoned decision, not just a document revision number. In the illustrative example, an unsupported population row stays open until the evidence or scope decision has resolved it and the affected records agree. A new CER version cannot close that row by itself.
Questions that come up during a CER update
Does historical clinical evidence expire?
Age alone does not determine relevance. Assess whether the data still apply to the device, clinical question and current state of the art. Older evidence can remain useful, but the evaluator must explain its present contribution and limitations.
Can a low complaint rate replace clinical performance evidence?
Not by itself. Complaints and clinical performance data answer different questions, and reporting completeness and exposure estimates affect interpretation. Explain what the complaint dataset supports without extending it to outcomes it did not measure.
Does every legacy device need a new clinical investigation?
No universal answer follows from legacy status. Assess the applicable requirements and the sufficiency of the available evidence for your device. Do not assume either that previous certification removes the need for new evidence or that every update requires a new investigation.
How often should the CER change?
Set the update approach using the applicable requirements, device characteristics and evidence emerging from PMS and PMCF. Do not assume one interval fits every device or that a transition deadline pauses clinical evaluation work.
The useful outcome of an MDR CER update is a defensible clinical position. You know which evidence remains usable, which conclusions changed and which decisions cannot proceed without more evidence. That gives the clinical work a clear scope before the report grows longer.
Talk to Dovetail about the clinical gaps in your legacy-device CER.
