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.
Our position
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.
What we’re doing
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.
Timeline of key dates
Our timeline sets out the key dates for the adoption of the new EU Medical Devices Regulations.
2017
April 2017
- 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.
March 2017
- The Council of the European Union confirms its formal support for the final text.
2016
May 2016
- The European Parliament and Council of the European Union reach informal agreement on the final regulation texts.
2015
October 2015
- The Council of the European Union agrees its position on the Draft Medical Devices and IVD Devices Regulations, opening the way for informal, three-way ‘trilogue’ negotiations between the European Commission, Parliament and Council to reach final agreement.
- With the PHG Foundation, European Society of Human Genetics and other partners, we publish a joint statement ahead of negotiations [PDF 434KB].
2014
April 2014
- The European Parliament formally adopts its position on the draft regulations, including the genetic testing amendments made by the committee.
- With the PHG Foundation, European Society of Human Genetics and other partners, we coordinate a joint statement [PDF 384KB] highlighting concerns with the European Parliament’s position.
2013
October 2013
- The European Parliament adopts the report from its Committee on the Environment, Public Health and Food Safety, which proposes amendments to the draft Medical Devices and IVD Regulations, including on genetic testing.
September 2013
- The European Parliament’s Committee on the Environment, Public Health and Food Safety debate and vote on the proposed regulations.
January 2013
- We respond to a consultation [PDF 71KB] from the UK Medicines and Healthcare products Regulatory Agency on the draft proposals.
2012
September 2012
- The European Commission publish draft legislative proposals, including a draft regulation on IVD Medical Devices.