The European Commission published a legislative proposal amending the in-Vitro Diagnostics Regulation (IVDR), and more specifically amending the transitional provisions for certain in-vitro diagnostic devices and differing the application of requirement for in-house devices. The date of application of the IVDR remains on 26 May 2022 but the legislative amending act is extending several transitional provisions until 2028 depending on the scope of the devices and on a risk-based approach. Extended transitional periods are also provided for certain requirements for In-house devices. In order to clearly present you the amendments proposed by the Commission we made a short recap table that you may see below the article.
BioMed Alliance welcomes the publication of this proposal and we are working on a reaction. The legislative amending act was necessary to ensure proper IVDR implementation and to answer serious concerns of the diagnostic health community about the IVDR implementation status and the potentially disastrous consequences for diagnostic practice and patients’ safety in the European Union. However, we have some reservations regarding the provisions on In-house devices.
The next steps are that the European Parliament and the Council must adopt the proposal and the MDCG and the Commission will continue to work according to the Joint Implementation Plan. We are also carrying on our work and advocacy efforts to ensure necessary steps are taken, guidance documents will be published shortly and the Notified Body capacity will be increased.
2022