EU ruling on medical devices
News / Published: 14 June 2016
The European Council and Parliament have agreed new rules on the manufacture and sale of medical devices and diagnostics. The rules cover devices such as hip replacements and diagnostics such as genetic tests and home pregnancy kits.
A review of existing regulations was launched in 2012, after breast implants manufactured by French company Poly Implant Prothèse (PIP) were found to contain harmful non-medical grade silicone.
The new rules require all manufacturers to show their devices are safe before they are brought to market.
The rules also cover genetic tests, which are an increasingly important element of healthcare.
Wellcome had expressed concerns over EU proposals to introduce blanket requirements for all genetic tests. We felt that this ‘one-size-fits-all’ approach:
- was disproportionate and potentially restrictive
- failed to take account of the different ways genetic tests are delivered across the EU.
We worked with the PHG Foundation, the European Society of Human Genetics and other partners to highlight these concerns and propose alternatives.
"We are very pleased that the European institutions listened to these concerns and found a compromise that takes a proportionate approach to the risks of different genetic tests," said Dr Will Greenacre, policy officer at Wellcome.
"The agreed text of the regulation will protect patients while maintaining access to genetic testing technologies across the EU."
The text of the agreement will be formally agreed by the Council and Parliament later this year. It will apply from 2021.
Read more about our policy work on EU medical devices regulations.