Regulatory Updates | HubMed

3 Articles

CER ×

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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