The transition to a new regulatory framework for medical devices in the European Union

This document provides an overview of the transition period from the Medical Devices Directives to the Medical Devices Regulation (EU) 2017/745. It explains the impact for medical devices being placed on the market during the transition period.

Summary:

• From May 2017 to May 2020, Medical Devices will start to transition from being CE marked under the two current (and separate) Medical Devices Directives – Directive 93/442/EEC and Directive 90/385/EEC  to being CE marked under the new Medical Devices Regulation (EU) 2017/745.
• However, the transition may last until at least May 2024 for those devices that are certified by a Notified Body under the current Directives.  No new certifications under the current Directives can take place after 26 May 2020.
• EU Member State authorities and Notified Bodies will continue to oversee the EU market, ensuring that all medical devices are safe and perform as intended, regardless of whether they are CE marked under the current Directives or the new Regulation.
• A medical device is not inferior simply because it is CE marked under one of the current Directives instead of under the new Regulation
• Regulatory documentation – such as Declarations of Conformity, certificates, labels and instructions for use – issued under the current Directives, may remain valid until up to approximately May 2024, and can both continue to be used and will lawfully remain in circulation.