mdr

European Notified Bodies Association Raises Concerns About MDR, IVDR Revisions

Europe's medical device notified bodies are sounding the alarm: proposed revisions to the MDR and IVDR could quietly strip away the oversight safeguards that keep patients safe. Here's what's changing — and why it matters.

EU Commission Updates MDR/IVDR Transitional Provisions

The Commission of the European Union (EU) has modified the transitional provisions of its...

EU Commission Proposes to Extend MDR/IVDR Deadlines

The Commission of the European Union (EU) has proposed extending the transition period for...

EU’s MDCG Updates MDR Guidance

The Medical Device Coordination Group (MDCG) of the Commission of the European Union (EU)...

Industry Groups Call for 2-Year Extension of MDR Transition Period

Two leading medical industry groups in the European Union (EU) are calling on the...
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EU Commission Updates Biological Safety Standards Applicable under MDR

The Commission of the European Union (EU) has updated the list of standards that...

EU Commission Updates List of Harmonized Standards for MDR

The Commission of the European Union (EU) has updated its list of harmonized standards...

The EU’s MDR is Now in Effect

The European Union’s (EU’s) new regulation for medical devices sold or imported into the...

EUs MDR Date of Application Delayed Until 2021

In a major development for medical device manufacturers, the Parliament and Council of the European...

EU Commission Extends MDR Transition Period for Certain Class 1 Devices

The EU has approved a “correction” to its Medical Devices Regulation (Regulation (EU) 2017/745,...
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