Module 19 2021

24/05/2021

Technical documentation & Brexit

• In GB IVD’s will continue to be regulated by the IVD directive until June 2023. • But manufacturers of non-certificated CE- marked IVD’s must transition from the IVDD to the IVDR by 26 May 2022: • Unless they only want to market devices to Great Britain (GB) only. • Manufacturers can also obtain the UKCA mark by obtaining a certificate from a UK approved body or by self-certifying a general IVD.

The Organisation for Professionals in Regulatory Affairs

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Technical documentation & Brexit

• The CE mark will continue to be accepted in GB until June 2023. • Northern Ireland will accept the CE mark or the CE UKNI mark. • But GB will transition to new regulations requiring a mandatory UKCA mark as of 1 July 2023. • Although no details have been made public it is possible that the new regulations will be based broadly around the existing IVDR.

The Organisation for Professionals in Regulatory Affairs

14

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