In 2017, the EU introduced new rules for medical devices and in vitro diagnostics to ensure a better protection of public health and patient safety.
Despite considerable progress in transitioning to these rules and the additional time given to the sector to implement them, the transition remains slow. In 2023, the Commission took measures to ensure the availability of medical devices. Today, we are proposing to take additional steps:
- to ensure the availability of in vitro diagnostics by allowing more time for manufacturers to transition to the new rules, subject to certain important conditions.
- to enhance transparency and protect patient care by speeding up the launch of some parts of the European Database on Medical Devices – EUDAMED
- to provide healthcare systems with more time to safeguard patient care by obliging manufacturers to notify in case of disruption of supply of certain medical devices and in vitro
The Proposal will now be put forward to the European Parliament and Council for adoption.
Source: European Commission