BSI Notified Body Highlights Crucial Elements Related To EU’s MDR Amending Regulation
BSI Group has issued a useful Q&A document on how it sees the new EU MDR amending Regulation, which extends the transition deadlines for legacy medical devices, impacting manufacturers and their relationship with notified bodies.
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How And Where Tougher Clinical Evaluation Measures Under EU MDR Cause Challenges
A first of its kind study examines how large compared with medium companies are coping with the EU’s strict clinical evidence requirements. The results show how it is the more stringent demands for high-risk devices that are leading to device removals as well as market launch outside the EU.
Annex XVI Products Set To Have More Time To Comply With MDR
Devices without a clinical purpose that fall under the scope of the EU’s Medical Device Regulation need to be tightly regulated. Now it looks as though manufacturers will have more time to comply if they need it.
EU Guidance On 'Significant Change' Meaning For Legacy Products Is Updated
Now that the deadlines for legacy products under the EU’s Medical Device Regulation have been extended, the vital guidance on the meaning of “significant change” and conditions for ongoing sale of these products has also been updated.