Regulation (EU) 2026/977: When Do New CE Certification Timelines Apply? The new timelines introduced by Commission Implementing Regulation (EU) 2026/977 have attracted considerable attention across the medical device and in vitro diagnostics sectors. More predictable noti... CER EU MDR IVDR (In Vitro Diagnostic Regulation) MDR Compliance Medea 26 Oct 2026 0 96
Navigating EU MDR Annex XIV: How to Eliminate Literature Review Bottlenecks in Clinical Evaluations Introduction The European Medical Device Regulation (EU MDR 2017/745) has fundamentally transformed the regulatory landscape for the MedTech sector. Moving away from the historical pre-market approval... Clinical Evaluation Report EU MDR MDR Compliance Medea Technical Files 1 Jun 2026 0 391
What is EUDAMED and Why is it Critical for Medical Device Manufacturers? Introduction Digital transformation has fundamentally disrupted the life sciences sector, and regulatory frameworks are evolving rapidly to keep pace. At the center of this compliance revolution sits ... Clinical Evaluation Report EU MDR EUDAMED MDR (Medical Device Regulation) MDR Compliance Medea Technical Files 25 May 2026 0 300