Module 19 2021

24/05/2021

IVDR Annex IV ‘The EU declaration of conformity shall contain the following information’:

8 . ‘ Where applicable, the name and identification number of the notified body, a description of the conformity assessment procedure performed and identification of the certificate or certificates issued; 9. Where applicable, additional information; 10. Place and date of issue of the declaration, name and function of the person who signed it as well as an indication for, and on behalf of whom, that person signed, signature.’

The Organisation for Professionals in Regulatory Affairs

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IVDR transition, Article 110, simplified

● New IVD’s not previously CE marked – Must comply with IVDR from 26 May 2022 ● Legacy IVD’s CE marked to IVDD, without NB certificate, i.e. most IVD’s – Must comply with IVDR from 26 May 2022 ● Legacy IVD’s CE marked to IVDD, with NB certificate – Must comply with IVDR from expiry of certificate – All certificates become void by May 2024 ● Devices lawfully placed on the market under IVDD – ‘prior to 26 May 2022 … may continue to be made available on the market or put into service until 27 May 2025’

The Organisation for Professionals in Regulatory Affairs

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