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:

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

March 2017

2016

May 2016

2015

October 2015 

2014

April 2014 

2013

October 2013

September 2013

January 2013

2012

September 2012 

Contact us

If you have any questions, contact Katherine Powell

Topics

European Union

The European Union supports science through legislation, funding opportunities and programmes to help cross-border collaboration.

Influencing policy

Science policy affects a broad range of issues, ranging from data sharing and gene editing, to intellectual property and regulation.

Regulation

Regulation creates an environment where research and innovation can flourish. 

Reports and consultations