How Manufacturers Can Demonstrate Their 'Outdated' Legacy Certificates Remain Valid
It’s here! Notified bodies now have a means of showing which products are eligible to benefit from extended timelines as a result of the recent EU Medical Device Regulation amending regulation.
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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.
MDR Amending Regulation Officially Published And Already In Force
The deadlines for legacy products under the Medical Device Regulation have changed. Here are the essentials that all medtech players need to understand in how the MDR has now been amended.
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.