Breaking Down EU MDR Implementation for Class 1 Medical Devices Following the one-year delay in the MDR Date of Application, the Class I medical devices, in the lowest risk class, must also conform to the new European Medical Device Regulation (EU MDR) to the end of their required performance lists. Despite any extension period, [...]
Overview The EU MDR and IVDR will usher in increased post-market surveillance (PMS) requirements for all MedTech companies. A PMS plan will incorporate a Post-Market Clinical Follow-up (PMCF) plan or justification for why it is unnecessary. Higher-risk devices and IVDs will require a Periodic Safety Update Report (PSUR). While for lower-class devices, a [...]
Guide - MDCG endorsed documents and other guidance documents. The majority of documents on this site need approval by the Medical Device Coordination Group (MDCG) as per Article 105 of the MDDR and Article 99 of IRD. The document should draft in coordination with interested parties. Each representing various group groups and being denominated [...]
The Post Market Surveillance Series (Part 2) Part 2: Vigilance and Incident Reporting In the second post of our Post Market Surveillance series we’re going to dive into incident reporting and vigilance. This section of MDR deals with how your firm monitors for and then responds to any events reported [...]
The Post Market Surveillance Series (Part 1) Post Market Surveillance in MDR There are only a handful of explicit things that you HAVE to do under MDR for PMS, however there are a lot more things you SHOULD be doing to continuously monitor and update your products’ risk-benefit analysis. Because [...]
