The following new legislation will be applicable within the EU
The EU has revised the legal framework of the current 3 Directives to reflect progress over the last 20 years. Adopted in May 2017, the new rules will fully apply after a transitional period. In addition, to ensure a smooth transition from the Directives to the Regulations and to avoid market disruption several transitional provisions are in place until 2025.
The new regulations contain a series of extremely important improvements to modernise the current system. Among them are
- stricter previous control for high-risk devices via a new pre-market scrutiny mechanism with the involvement of a pool of experts at EU level
- reinforcement of the criteria for designation and processes for oversight of notified bodies
- inclusion of certain aesthetic devices that present the same characteristics and risk profile as analogous medical devices under the scope of the regulations
- a new risk classification system for in vitro diagnostic medical devices in line with international guidance
- improved transparency through a comprehensive EU database on medical devices and a device traceability system based on a unique device identification
- introduction of an ‘implant card’ for patients containing information about implanted medical devices
- reinforcement of the rules on clinical evidence, including an EU-wide coordinated procedure for authorising multi-centre clinical investigations
- strengthening of post-market surveillance requirements for manufacturers
- improved coordination mechanisms between EU countries in the fields of vigilance and market surveillance
All actors involved with medical devices, from their manufacture to their use, will have to comply with the new regulations by May 2021 (May 2022 for in vitro diagnostic medical devices). It is important that all actors are fully aware of the changes and start preparing for the implementation of the new regulations as soon as possible.
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- New rules to ensure safety of medical devices
- Press release: new EU rules on medical devices
- Factsheet: key changes set out in the regulations
- Getting ready for the new regulations
- Topics of interest
- Web banners
- Infographics: 'New Regulations' and 'Transition timelines'
- Stakeholder engagement toolkit compiled in all EU languages (as well as Chinese, Arabic, Japanese and Russian). The toolkit includes an e-mail that stakeholders can use to inform their members about the new Regulations, as well as a news article and inspirational social media posts