Clinical Evaluation Report Writing for Medical Device Manufacturers

MDR Annex XIV requires the clinical evaluator’s qualifications to be documented and justified, and Notified Bodies review the CV. In practice, this means a relevant degree, documented experience in the device area and in clinical research methodology, and a written justification specific to the device.

There is no licence or register for clinical evaluators, but the requirement is applied in practice, and manufacturers often discover it at submission. We provide the named evaluator, the CV, the declaration of interests and the written justification as part of the deliverable.

MDR requires the clinical evaluation to be updated throughout the device lifecycle. For Class III and implantable devices the PMCF evaluation report is updated at least annually; for other classes the cadence is set by risk and justified in the plan, commonly every two to five years.

The evaluation should also be updated when the state of the art changes, when PMCF data become available or when a safety signal appears. The plan should state which of these events triggers an update.

Yes, but the bar is considerably higher than under the Directive. MDCG 2020-5 requires technical, biological and clinical equivalence to be demonstrated separately, and for implantable and Class III devices the manufacturer must have a contract giving sufficient access to the equivalent device’s technical documentation.

Most equivalence arguments fail on the data-access requirement. We assess it early, because if it cannot be met, the evaluation route changes and so does the rest of the work.

The state of the art describes what current practice achieves for the indication, based on clinical guidelines, systematic reviews, comparable devices and alternative therapies, including typical performance and known complication rates.

It is presented separately because it is the benchmark against which your device is measured. Combined with your own evidence, it no longer works as a comparison, and reviewers look for it specifically. For legacy devices under MDCG 2020-6, it is central to whether the clinical evidence is sufficient.

It cites a withdrawn standard. The fourth edition, ISO 14155:2026, was published on 23 March 2026 and replaced the 2020 version.

This is not a safety issue in itself, but it shows a reviewer when the file was last reviewed, which can affect how closely the rest of the file is examined. It is also simple to correct.

Yes, and they belong together. The CER identifies the residual gaps; the PMCF plan says how they will be closed; the PMCF evaluation report closes them and feeds the next CER update.

When they are prepared separately, the gaps identified in one document may not match the gaps addressed in the next, which is itself a finding. For Class III and implantable devices this cycle runs annually.

Yes. The Summary of Safety and Clinical Performance is mandatory for Class III and implantable devices under MDCG 2019-9 Rev 1, and it has to be written for patients as well as for healthcare professionals.

Writing for both audiences is the main challenge: the patient section must be accurate and easy to understand, which draws on plain language summary skills as well as regulatory writing.

No. Notified Bodies are accredited to assess devices, and an organisation that writes your clinical evaluation cannot also assess it.

We write the plan and the report; you review, approve and sign them. You remain the manufacturer and retain responsibility for the device, and this separation keeps the document valid for assessment.