We inform you that the European Commission has published a Proposal for a Regulation for the targeted revision of Regulations (EU) 2017/745 on medical devices (MDR) and (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).
The proposal aims to improve the effectiveness of the regulatory framework, reduce delays in the certification process, and enhance innovation and the availability of medical devices and in vitro diagnostics on the European market, without compromising the high level of protection of public health and patient safety.
Interested parties (healthcare professionals, economic operators, the public) are invited to participate in the public consultation and call for submissions conducted by the European Commission, in the context of the targeted review of Regulations (EU) 2017/745 and 2017/746.
The Proposal for a Regulation has been put out for public consultation through the European Commission platform at the following link:
Product Evaluation Department
Department of Health Equipment Evaluation
