R&Q's Blog

Medical device industry news and trends - and the resources to understand and act on them.

 

MEDDEV 2.7/1 & CERs: Questions and Answers

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.

MEDDEV 2.7/1 & CERs: Know the Changes and What to Do [Webinar]

Part of your month, [almost*] every month: R&Q Intelligence Series webinars are held on the fourth Tuesday of every month. These free webinars from some of the medical device industry's leading-most experts are designed for reporting on and analyzing the top industry trends and topics in the medical device space, each providing key and actionable takeaways for attendees. Slides and recordings will be made available to all registrants. Next up: July 25th, where we'll discuss cybersecurity (*there will be no R&Q Intelligence Series webinar in June).

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