EU - Commission publishes proposal for changes to MDR and IVDR

The EU-Commission has published their proposal to modify the Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR). The proposal is part of a larger package with proposals for regulatory changes in the health sector.

The press release contains additonal Q&A documents and factsheets. The text with the propased changes is here. The adaptations are voluminous (including explanations and statements about 200 pages of text) and affect all parts of the Regulations. For a detailed evaluation the separate changes must be considered in the context of the original texts.

The proposals will now be submitted to the European Parliament and the Council for adoption, starting the further legislative process. This may lead to changes before a final adoption.