Extension to the MDR Transition Timelines

Extension to the MDR transition timelines – impact on manufacturers and Notified Bodies

The EU Commission proposal to extend the MDR transition timelines

Anyone involved in transitioning medical devices from the Directives (MDD/AIMDD) to the MDR in the EU.

The new transition timelines, which devices benefit from them and under what conditions.
Which devices covered by expired MDD/AIMDD certificates can benefit from longer timelines.
Abolishment of the sell-off provisions in the MDR and its impact.
Transfer of appropriate surveillance from your Directive Notified Body to the MDR Notified Body.

Speakers

Speaker

Head of UK Approved Body, Regulatory Services, BSI

Speaker

VP, Regulatory Services, BSI

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