Negotiations continue for the medical devices and IVDs directives

Posted on 03.03.2016

Since the start of 2016, interinstitutional negotiations on the revisions of the Medical Devices and In Vitro Diagnostics Directives have continued. The much expected first Trilogue meeting under the Dutch Presidency took place on February 17th. Discussions revolved around scrutiny, genetic testing, liability insurance and clinical trials.

Last week, the Dutch reiterated their hope for Council, European Parliament (EP) and Commission to reach a compromise by July 2016.At the EP ENVI Committee meeting of February 23rd, Giovanni La Via, Chair of the Committee, confirmed this and declared discussions are well underway. He however warned that the above-mentioned topics would require full-time work and compromise.

One other Trilogue meeting can be expected to take place before the Dutch Presidency reconvenes to assess progress on the files in March 2016.

More news may come out of the meeting of EU Ministers of Health, on March 7th.

Against that background, MedTech Europe/EDMA/Eucomed will continue monitoring the two files and step up work on the implementation phase.

For any further information, please contact Delphine Roulland.