Proposal amends medical device regulations to simplify rules and reduce compliance burden

Original title: Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devi

The European Commission proposes amendments to the medical device regulations (MDR and IVDR) aimed at simplifying rules and reducing the compliance burden for manufacturers and competent authorities. The proposal also updates Regulation (EU) 2024/1689 (Artificial Intelligence Act) by amending the list of Union harmonisation legislation in its Annex I to ensure coherence with the medical device regulatory framework. Additionally, the proposal enhances the European Medicines Agency's support for expert panels on medical devices. These changes are designed to streamline the regulatory process while maintaining the safety and performance standards required for medical devices in the EU market.

What changed

• Amendments to Regulation (EU) 2017/745 (Medical Devices Regulation) and Regulation (EU) 2017/746 (In Vitro Diagnostic Regulation) to simplify and reduce the burden of compliance rules
• Amendments to Regulation (EU) 2022/123 to enhance the European Medicines Agency's support for expert panels on medical devices
• Amendments to Regulation (EU) 2024/1689 (Artificial Intelligence Act) regarding the list of Union harmonisation legislation referred to in Annex I
• Streamlined procedures and reduced administrative requirements for medical device manufacturers and notified bodies

Who is affected

Medical device manufacturers, in vitro diagnostic device manufacturers, notified bodies, competent authorities, and healthcare providers in the EU market. The proposal affects all organizations placing medical devices and in vitro diagnostic devices on the EU market.