Module 19 2021

24/05/2021

Technical documentation transition timelines

• It follows that it will be desirable to have a good understanding of IVDR requirements. • Notified bodies are under great pressure and may have long lead times. • In order to meet the timelines for NI / EU, manufacturers of legacy devices should have started work on their transition plan to IVDR already as the deadlines are: • Devices self-certified under IVDD, by 26 May 2022 • Devices with NB certificates under IVDD, by the expiry date of the certificate or 26 May 2024, whichever comes first.

The Organisation for Professionals in Regulatory Affairs

15

Technical documentation

What is it?

The Organisation for Professionals in Regulatory Affairs

16

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