Regulatory Updates | HubMed New

3 Articles

MDR Compliance ×

EU MDR 2017/745: The Compliance Deadline That Cannot Be Ignored — And What Happens If You Miss It

Five years after its full application, EU MDR 2017/745 is no longer a transition challenge. It is the new standard. And Notified Bodies are running out of patience. When the EU Medical Device Regulati...

CER Clinical Evaluation Report Compliance Risk Management EUDAMED MDR (Medical Device Regulation) MDR Compliance Medical Devices Time-to-Market

4 Jul 2026

0 98

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

0 222

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

0 148