Clinical Evaluations are the new cornerstone of medical device regulation in the EU under the Medical Device Regulations (MDR)
The new Medical Device Regulation (MDR) will increase scrutiny of the clinical data in the Clinical Evaluation Report (CER) for EU market approval. In the meantime, since June 2016, the European guidance on clinical evaluations, MEDDEV 2.7/1 has been revised as a basis for meeting the increased requirements for clinical data under the new rules.
One of the most significant changes relates to the definition of equivalence. Many devices that were CE marked on this basis will require re- evaluation to ensure they meet the new requirements under the Medical Device Regulation (MDR).
Furthermore, clinical evaluations of new high risk devices will be subject to review by expert panels at the European level.
MedPass has an in-depth understanding of the new requirements gained from our participation in the Commission working group that developed the new MEDEV 2.7.1 revision 4. Furthermore we stay up to date on the evolutions in interpretation of the new requirements through our ongoing relationships with EU regulatory stakeholders. From scoping and completion of literature reviews, through gap analysis, study design and sample size calculation to development of Clinical Evaluation Plans (CEPs), MedPass provides expert scientific and regulatory advice to ensure clients have a clear understanding of the clinical evaluation process that will be applicable to their medical devices under the new requirements.
However, when it comes to writing the final Clinical Evaluation Report (CER), knowledge of the MEDDEV 2.7.1 is not sufficient. A comprehensive Clinical Evaluation Report (CER) also takes into account information from the Risk Management and Post Market Surveillance of the product. MedPass is also expert in preparing Risk Management Plans and Reports and Post Market Surveillance Plans and Reports.
With such broad expertise in the area of Clinical Evaluation, MedPass can provide truly comprehensive or high level expert advice depending on the clients’ needs.