· Oct 15, 2021

European Commission proposes to postpone the application of the regulation on in vitro diagnostic medical devices

The Commission proposed on Thursday to extend to three years the transitional periods for the application of the new European regulation on in vitro diagnostic medical devices (IVDs), which is scheduled to enter into force on May 26, 2022, to avoid the risk of supply disruption.
One of the main changes that the new regulation introduces is the increased role of independent conformity assessment bodies, also known as "notified bodies", which will be responsible for controlling 80% of IVDs, compared to 8% currently.
The Commission wants to extend the transition period, provided for in the current regulation until 2024, by adapting it according to the devices: for high-risk IVDs such as HIV or hepatitis tests (class D) and certain influenza tests (class C), the transition period would end in May 2025 and May 2026, respectively, and for low-risk devices such as class B and A sterile devices, in May 2027.
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