The EU Medical Devices Regulation and In-Vitro Medical Devices Regulation (the “Regulations”) were adopted on 5 April 2017, following a final vote at the European Parliament. The Regulations were proposed by the Commission in 2012 (as discussed in our previous Law-Now), and have now been finalised following trilogue negotiations between the European Parliament, European Council and European Commission.
These two new Regulations will replace the three existing Directives on medical devices and IVDs, and aim to modernise the original rules and bring together best practices from existing Commission guidance, and to help ensure all medical devices and IVDs across the EU are safe, and perform to a high standard.
The new Regulations also seek to promote legal certainty across the EU, while still allowing for innovation and competitiveness within the medical device and IVD sectors. Key points of the Regulations identified by the Parliament include:
- an "implant card" for patients, enabling patients and doctors to track which product has been implanted,
- a new device identification system based on a unique device identifier (UDI), with more information to be made publicly available via EUDAMED (an EU-wide database on medical devices, to be set up by Spring 2020),
- stricter controls on notified bodies, which will have to employ medically skilled people,
- random inspections of producers’ facilities after devices have been placed on the market,
- an additional safety checking procedure for high risk devices, such as implants or HIV tests. Not only a notified body, but also a special committee of experts, will check that all requirements are met,
- an expansion to cover previously unregulated aesthetic products which nonetheless carry a risk of harm to consumers (e.g. coloured contact lenses that do not correct vision), and
- clinical evidence of medical device safety to be provided by manufacturers (as for medicines), especially in the case of higher risk classes.
The Regulations are expected to be published shortly in the Official Journal of the European Union. The Regulations will apply three years after they enter into force; as part of the transitional period, the Regulations allow for certificates issued under the current directives to remain valid for an additional period after their application date (3 years after the entry into force for medical devices and 5 years for the in vitro diagnostic medical devices). The Regulations will be directly applicable in all Member States, which will help standardise conditions for patients and industry stakeholders across the EU. Following publication of the Regulations, the focus will shift to implementation as the Regulations each contemplate significant delegated and implementing acts to be introduced, which are expected to contain much more granular detail which will supplement the general provisions of the Regulations.