As explained in previous newsletters, this amending Regulation does not change any requirements of the IVDR in substance but only changes the transitional provisions stipulated in Article 110, to allow a progressive rollout. The existing transitional period for devices covered by a certificate issued under IVD Directive 98/79/EC have been extended until 26 May 2025 and tailored transitional periods have been introduced for devices that must undergo a conformity assessment involving notified bodies for the first time under the IVDR. The length of the transitional periods depends on the type of device. Class D devices have until 26 May 2025, Class C until 26 May 2026, and Class B and sterile Class A devices have until 26 May 2027. Furthermore, the amending Regulation introduces a transitional period for the requirements for devices manufactured and used within the same health institution (‘in-house devices’). 

What does this mean to you?

This amending Regulation provides IVD manufacturers with more time to transition the existing devices from the IVD Directive 98/79/EC to the IVDR 2017/746. With more time to prepare for the application of the EU new rules, the European Commission ensures there is a continuous supply of essential IVDs on the market, while not compromising on safety. It is still highly advisable for all manufacturers to prepare for certification under the IVDR as soon as possible and not wait until the end of the transition period.

Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us

 

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