Clinical evaluation requirements have been changing, with the latest impact coming from MEDDEV 2.7/1 Rev 4. Preparing for and meeting these requirements is important because the grace period offered by some notified bodies is ending and clinical evaluation reports (CERs) are being audited for compliance with the latest MEDDEV revision.
Furthermore and once the regulation comes into force, the European Medical Devices Regulation (MDR) will impact CERs as well. It is important to be proactive to ensure CERs will meet your notified body expectations. You must review your clinical strategy carefully.
R&Q recently presented the webinar, MEDDEV 2.7/1 & CERs: Know the changes and what to do. Towards the end of the session we answered several questions, a sample of which are below. To see all questions and answers from the session - along with the slides and recording - check out the on-demand webinar.