Most CERs fail on the same handful of things 

A clinical evaluation plan (CEP) defines how a manufacturer will evaluate the clinical evidence for a device under EU MDR. Annex XIV, Part A requires it to state the intended purpose, the general safety and performance requirements that need clinical data, the intended clinical benefits and the methods for assessing safety and benefit-risk.

Write the plan before the evaluation, and update it when the claims or the device change. A plan written after the report cannot show how the evaluation was meant to be done. The requirements are in MDR Annex XIV.

How should the literature search for a clinical evaluation be run?

A literature search for a clinical evaluation must be reproducible. It documents the databases searched, the search terms, the date range and the inclusion and exclusion criteria. Each source is then appraised for relevance and quality, with a stated weight, and unfavorable data is included alongside favorable data.

MEDDEV 2.7/1 revision 4 describes the search and appraisal steps in detail. Keep the search protocol and the appraisal records, because they are what a reviewer will use to repeat your search.

What clinical data can support a clinical evaluation, and when is equivalence allowed?

Clinical data for an EU MDR clinical evaluation can come from clinical investigations of the device, published literature on the device or an equivalent device, and post-market data. Relying on an equivalent device means showing similarity in technical, biological and clinical characteristics.

For implantable and class III devices, relying on another manufacturer's device also requires a contract that gives you access to that manufacturer's data (MDR Article 61). The equivalence criteria are explained in MDCG 2020-5. Check early whether this route is realistic for your device.

How do clinical claims connect to the benefit-risk conclusion?

Every claim a manufacturer makes for a device must be supported by clinical data. The plan defines the clinical benefit, the acceptance criteria and the state of the art, and the report then concludes whether the benefit-risk profile is acceptable against those criteria.

The conclusion has to be consistent with your risk management file and your instructions for use. MDR Article 2(53) defines clinical benefit as a positive impact on the health of an individual, expressed as meaningful, measurable, patient-relevant clinical outcomes, or a positive impact on patient management or public health.

What is post-market clinical follow-up (PMCF) and what does it need?

Post-market clinical follow-up (PMCF) is a continuous process under EU MDR Annex XIV, Part B that updates the clinical evaluation with real-world data. A manufacturer needs a PMCF plan and a PMCF evaluation report, or a documented justification for why specific PMCF activities are not appropriate.

The MDCG has published templates for both documents: MDCG 2020-7 for the plan and MDCG 2020-8 for the evaluation report. The plan should address the open questions from your clinical evaluation, such as long-term safety or rare events. Our PMCF surveys and studies page describes how we run them.

How often must a clinical evaluation report be updated?

A clinical evaluation report (CER) is a living document. EU MDR Article 61(11) requires manufacturers to update it throughout the life of the device with data from the PMCF plan and the post-market surveillance plan. For class III and implantable devices, the PMCF evaluation report must be updated at least annually.

The summary of safety and clinical performance is updated on the same cycle where one is required. For other devices, the manufacturer sets the update frequency based on risk and documents the reasoning. The wording is in MDR Article 61(11).

Get support with your clinical evaluation

Qserve's consultants support manufacturers at every stage this check covers, from the plan and the literature review to the report and post-market clinical follow-up.