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Press Release New medtech regulations

Council and Parliament representatives confirm agreement on medical device and IVD regulations

Posted on 15.06.2016


Brussels, 15 June 2016 – The medical technology industry welcomes the vote on the consolidated medical device and in vitro diagnostics regulation texts by representatives of the Council and the Parliament today.

The Environment, Public Health and Food Safety (ENVI) Committee of the European Parliament and Council’s Committee of Permanent Representatives (COREPER) voted to endorse the trilogue agreement this afternoon. The texts can be downloaded and viewed on the European Parliament website.

MedTech Europe, the alliance of the medical device association Eucomed and the in vitro diagnostics association EDMA, continue to recognise the importance of these regulations towards the sector and the healthcare continuum at large.

“Medical technologies save lives, improve health and contribute to sustainable healthcare. And many of the proposed updates in the regulations are welcomed by our industry as they will enhance patient safety and facilitate access to new technology” says Serge Bernasconi, CEO of MedTech Europe.  “I believe that the new regulations are critical in filling in the gaps of the existing laws and in bringing a more harmonised set of guidelines across the region”, he adds.

EDMA and Eucomed have already begun working on an in-depth analysis of the regulations to assess the overall impact towards the industry. At the same time, EDMA and Eucomed are putting in place plans to provide active guidance and expertise for members to comply smoothly with the new regulations.

The consolidated texts are expected to undergo legal review and language translations in the next coming months and are expected to be formally adopted at the end of 2016. The regulations would then apply to the medical devices and to the in vitro diagnostics sectors by 2020 and 2022 respectively.


MedTech Europe is an alliance of European medical technology industry associations. The Alliance was founded by EDMA, representing the European in vitro diagnostic industry, and Eucomed, representing the European medical devices industry.

Our mission is to make value-based, innovative medical technology available to more people while supporting the transformation of healthcare systems onto a sustainable path. We promote a balanced policy environment that enables the medical technology industry to meet the growing healthcare needs and expectations of its stakeholders. For more information, visit