Stella Kyriakides, Commissioner for Health and Food Safety, said: The COVID-19 pandemic has shown how essential it is to have accurate diagnostics and a robust regulatory framework for in vitro medical devices. Shortages at this point in time are unthinkable. The pandemic has imposed unprecedented challenges also for our medical devices industry.
However, the proposal of the EC does not change any substantial requirements but would change the transitional provisions to allow a progressive introduction of the IVDR:
The Commission also proposes a deferred application of the requirements for devices manufactured and used within the same health institution (‘in-house devices').
No change is proposed for CE-marked devices that do not require notified body involvement under the IVD Regulation or for devices that are ‘new', i.e. devices that have neither a notified body certificate nor a declaration of conformity under the current Directive 98/79/EC. For those types of devices, the IVD Regulation will therefore apply from 26 May 2022 as planned.
The Proposal will now go to the European Parliament and Council for adoption. It comes along with a Q&A document which offers more detailed information on the subject.
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