Regulatory Updates

Your essential guide to MDR, IVDR, and EUDAMED compliance in an evolving global landscape

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

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Top 5 Reasons Notified Bodies Challenge CERs Under EU MDR (And How to Avoid Them)

When a Medical Device Manufacturer receives a list of non-conformities or a request for additional information from a Notified Body, the cause is rarely structural or formatting-related. Under the Eur...

CER Clinical Evaluation Report Compliance Risk Management EU MDR EUDAMED MDR (Medical Device Regulation) MDR Compliance SOTA (State of the Art)

7 Oct 2026

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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

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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

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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

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