Module 16 2022

9/2/2022

Major Obstacles and Business Risks

• The approximately 20,000 legacy certificates will thus not all to be transferred to the MDR by the end of the transition period in May 2024.

• Currently, only about 1,500 MDR certificates have been issued. Multiple times that amount is pending to the Notified Bodies as an application .

• It is foreseeable that the situation will come to a dramatic head in 2024 .

• Many medical devices will not make the transition into the MDR on time. There is a threat of supply bottlenecks, innovation bottlenecks and distortion of competition.

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Major Obstacles and Business Risks

Source: https://www.team-nb.org/wp-content/uploads/2020/12/Team-NB-PositionPaper-ExpiringCertificates-20201215.pdf

The Organisation for Professionals in Regulatory Affairs

9/2/2022

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