If the clinical evaluation had already taken off with MEDDEV 2.7.1, rev. 4, the European Regulation of DMs 2017/745, especially through its article 61 and Annex XIV, gives it all its credentials. Whatever the class of MD and after the preparation of a Clinical Evaluation or CEP (established according to Annex XIV.A), a Clinical Evaluation Report (CER) documenting this evaluation and the resulting clinical evidence is necessary, the level of proof being related to the risk class of the MD and its destination. The clinical benefits for the patient (not to be confused with clinical performance) will be defined and quantified.

On its own, the CER can be seen as the biography of your medical device. It will be carefully examined, during the assessment of the technical documentation (of which it is one of the cornerstones), by the notified bodies who will verify its alignment with the instructions, the risk analysis, the Summary of Safety and Clinical Performance and the integration of the data from PMS / PSUR and PMCF reports)

Also, to follow the recommendations of the MDCG guides relating to clinical evaluation (Guidance – MDCG endorsed documents and other guidance | Public Health (europa.eu)), including the MDCG 2020-13, as well as the guides issued by the Notified Bodies, is a tedious certainly but effective mean to avoid the pitfalls of clinical evaluation. One of the most risky is the equivalency, the demonstration of which for implantable and class III devices is the responsibility of Mission Impossible. Adding a touch of Scrutiny Process and CER can quickly become your worst nightmare if you are a manufacturer of Section 54 DMs

Thus, do not hesitate to contact us. From diagnosis to the definition of the clinical strategy, completion of the CEP, the bibliographic search report (state of the art and on the device under study) and the preparation of the CER, we can be your breadcrumb trail.