The Second Corrigendum of Medical Device Regulation (MDR) 2017/745 Offers Manufacturers a 4-Year the Grace Period for Eligible Class I Medical Devices
Author: Dr. Suzanne Broussard | August 10, 2020 The European Parliament adopted a Second Corrigendum of MDR 2017/745 to address the serious possibility for shortages of reusable class I medical devices under the […]
The European Commission Pledges Make the Different Eudamed Modules Available On A Rolling Basis
Author: Dr. Suzanne Broussard One of the recent announcements in the everchanging medtech sector is that the newest European database on medical devices (Eudamed 3) will roll out modules as they become functional. Eudamed 3 is the cornerstone for the new medical device regulations (MDR) and […]
[FREE WEBINAR] How to Assess Your CER for MDR Readiness, Part 2: Clinical Data Sources, Equivalence, and Risk/Benefit Analysis
Get a copy of the slides from this webinar or click to watch the recording. In this second part of our 2-part webinar series, Criterion Edge will continue to present […]
