Module 16 2022

9/2/2022

Major Obstacles and Business Risks

The Organisation for Professionals in Regulatory Affairs

9/2/2022

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Major Obstacles and Business Risks

• The number and capacities of the Notified Bodies under the MDR are still far too small to transfer all existing devices to the MDR on time. Currently there are only 30 Notified Bodies. Many manufacturers – for example of surgical instruments or software – have to conclude new contracts with Notified Bodies. • The transition period for the validity of the old certificates ("grace period") until May 2024 and the sell-off period until May 2025 were not adjusted when the start of validity was postponed – despite the effects of the Corona pandemic. The expected shortages therefore remain and have even increased.

The Organisation for Professionals in Regulatory Affairs

9/2/2022

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