EU medical devices regulations
The European Union (EU) is revising regulations governing the manufacture and sale of medical devices.
It's introduced two new regulations: Medical Devices Regulation and In Vitro Diagnostic (IVD) Medical Devices Regulation, which were adopted in April 2017.
We support efforts to ensure that genetics and genomics discoveries develop into new treatments and technologies.
Because we fund the development of medical and IVD devices through our translational funding schemes, we broadly support the EU’s revision of the legislation.
We had specific concerns with amendments to the draft IVD regulation introduced by the European Parliament in 2013.
The amendments would, if enacted, have restricted access to genetic testing throughout the EU. They could have also restricted the development of new healthcare technologies based on genetic testing.
The IVD Regulation has now been adopted, and includes a more proportionate approach to genetic testing that rejects the most damaging aspects of the Parliament’s position.
Over the past four years, we’ve been working with the PHG Foundation, the European Society of Human Genetics and other partners to:
- raise awareness of our concerns about the draft IVD regulation at a European level
- make sure the new regulations are proportionate and support research.
We’ll continue to monitor the implementation of the regulations.
Our timeline sets out the key dates for the adoption of the new EU Medical Devices Regulations.
- The European Parliament votes to support the final text, concluding the formal adoption of the Medical Devices and IVD Devices Regulations. The Medical Devices Regulation will take effect in 2020. The IVD Regulation will take effect in 2022.
- The Council of the European Union confirms its formal support for the final text.
- The European Parliament’s Committee on the Environment, Public Health and Food Safety debate and vote on the proposed regulations.