EU: Proposal for step-by-step implementation of the IVDR published
The EU Commission has published a proposal for the step-by-step implementation of the in-vitro diagnostics directive, which enables manufacturers to place products in line with the previous directive on the market for longer. Find the press release here.
The detailed proposal intends to expand on Article 110 of the IVDR. Here, previously extended transition periods were intended for products that are covered by a valid IVD certificate. The proposal extends this regulation to all products that initially require a conformity assessment procedure involving a notified body in accordance with the IVDR. In these cases, a declaration of conformity issued before 26th May 2022 is sufficient in order to make use of the extended periods.
The duration of the period depends on the future class of the products: For Class D products, it expires in 2025, for Class C products in 2026 and for Class B and A sterile in 2027.
Additionally, regulations regarding in-house manufacturing are due to come into force later.