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Extension to the MDR transition timelines – impact on manufacturers and Notified Bodies
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.
Head of UK Approved Body, Regulatory Services, BSI
VP, Regulatory Services, BSI
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