Brussels – The EU Commission is proposing a gradual roll-out of the IVDR: Nothing in the regulation should change substantially, but the transition periods depending on the product class should. In addition to the consequences of the corona pandemic, the reasons given are the lack of notified bodies.
Health Commissioner Stella Kyriakides said that having more time to prepare for the implementation of EU regulations will ensure a continuous supply of essential in vitro diagnostics to the market without compromising on safety. The corona pandemic has shown how important precise diagnostics and a robust legal framework are. In addition, only six Notified Bodies have currently been named according to IVDR. According to the Commission, this "serious defect" makes it impossible for manufacturers to carry out prescribed conformity assessment procedures in good time.
The proposal does not make any changes to the requirements of the IVDR, but rather focuses on the transition periods. These depend on the type of product: higher-risk products, such as HIV or hepatitis tests (class D) and certain influenza tests (class C), are to have a transition period until May 2025 and 2026 respectively, while products with a lower risk Risk, such as sterile products of classes B and A, a transitional period until May 2027 is planned. Among other things, CE-marked products that do not require the involvement of a notified body according to IVDR are excluded; the ordinance will apply to them as planned from May 26, 2022. Stella Kyriakides combines the procedure with a direct appeal to the industry: "I call on all manufacturers to prepare for certification under the new regulation as quickly as possible and not to wait until the end of the transition period."
The proposal will now be submitted to the European Parliament and the Council for decision.
The full text of the Commission communication can be found at this link .
