Advocacy activities related to MD and IVD Regulations

Posted on 07.01.2016

As the New Year begins, we can look back on what has been achieved on the IVD and MD files: a lot has been accomplished in 2015 and much more is to come in 2016.

The Luxembourg Presidency successfully secured a General Approach for the IVD and MD Regulations, and then opened informal trilogue negotiations with the EU Commission and Parliament (EP). During the 5 political meetings and 8 technical meetings that took place between October and December 2015, all political issues of the dossiers were tackled.

In December 2015, The Netherlands announced that, under their Presidency of the Council, and during the next political and technical meetings scheduled until March 2016, substantial discussions will revolve around: scrutiny/special NBs, genetic testing, CMR chemicals, reprocessing, liability insurance, transitional measures and the validity of certificates, classification (rules 6, 19 and 21), and clinical investigations.

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

For any further information, please contact Delphine Roulland.

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