About 90 % of all in vitro diagnostic (IVD) manufacturer cannot benefit from transition period laid down in Article 110 of Regulation (EU) 2017/746 (IVDR) and must be ready for IVDR in May 2022. The new Regulation will replace the current Directive 98/79/EC on in vitro diagnostic medical devices from 26 May 2022.
The main change is the involvement of an independent notified body for the majority of IVDs including a conformity assessment procedure of a duration around 1 year. Only 8 % are already under the control of a notified body. Accordingly, IVD manufacturer will be faced with a considerable amount of work, new tasks and provisions.
The preparation of IVDR-complaint documents is becoming more and more important to successfully complete the assessment procedure.
Although the European Commission recommends extending the scope and timeline of the transitional provisions, time is running, anyway. Details on this are provided in the proposal for an amendment of Regulation (EU) 2017/746.
Are you facing the challenge of IVDR-preparation to keep the CE mark for IVDs?
Contact us for individual support and cooperation.
Do you want to focus on your business and not on regulatory obligations?
We are your partner for IVD regulatory services and can of course also take responsibility.
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Frauke Stamm
Senior Consultant
+49 251 928715-67
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Source: https://www.tentaconsult.com/2021/10/20/more-time-to-be-ready-for-ivdr/