The European Commission has published a proposal to amend MDR (EU 2017/745) and IVDR (EU 2017/746), introducing substantial regulatory changes aimed at simplifying compliance, improving predictability, and safeguarding device availability in the EU.
The proposal aims to improve the functioning of the current regulatory framework, in particular as regards the smooth functioning of the single market, while ensuring a high level of health protection for patients.
It builds on the key features of the existing framework, notably the decentralised approach (whereby responsibilities are allocated to the Member States) and the involvement of notified bodies in the conformity assessment procedure, like in other EU legislation based on the New Legislative Framework.
However, the aim is to establish a leaner and more cost-effective regulatory framework and to promote further harmonisation, creating a more competitive and innovative EU market.