The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
The agency said that manufacturers seeking certification for new products or maintaining existing certification may be affected by notified bodies that do not intend to transition to the new MDR, such as Lloyd’s Register and QS Zurich AG. Read More
“We wish to send a clear signal to the world that the Danish Medicines Agency is disconnected from economic interests of pharmaceutical and medical device companies,” the agency’s director general said. Read More
After months of criticism of the European Commission for the slow release of guidance on the EU’s new medical device regulations, the Commission released a flurry of documents on the Eudamed data exchange. Read More
Covington & Burling attorney Pamela Forrest offered insights into when devicemakers must file recall reports with the FDA to comply with 21 CFR Part 806 in a recent FDAnews webinar, flagging areas of confusion and how to avoid common errors. Read More
A combination of real-world evidence and periodic reporting to the FDA should be the cornerstone of how the agency regulates AI and machine learning in software as a medical device, Philips said in a comment on the agency’s draft framework document. Read More