Last February, a MEDDEV guideline detailing the process for updating clinical data evaluations in accordance with Regulation 2017/745 was published.
Clinical data evaluations are very often sizable documents. Updating them is a long and meticulous process.
Below, we set out a summary of the actions to be taken to get a clearer picture and to make this essential update as easy as possible!
We therefore need to:
- Replace the Essential Requirements (ER) of the Directive with the General Requirements of the MDR (Medical Device Regulation) (GSPR (General Safety and Performance Requirements)): changing these GSPR has an impact on several parts of the clinical data evaluation. We therefore need to review the document point by point and confirm that the information it contains meets the requirements.
- The novelties here are the GSPR on service life and usability. We need to look at what information to collect to meet these GSPR (identify the manufacturer’s pre-clinical data and the data from the literature). We therefore need to review the literature to integrate these new aspects in the publication search.
- Take into account the new provisions relating to PostMarket Surveillance and PostMarket Clinical Trials.
- Document a clinical evaluation plan.
- Evaluator qualification requirements have been enhanced. They now need to provide additional supporting documentation on their qualifications.
- Integrate the common specifications if there are any or when they appear.
Please do not hesitate to ask us for support in completing this update or in carrying out a post-update audit.