New Dutch Presidency enters the MD & IVD Trilogue

Posted on 04.02.2016

The Netherlands have taken over the Presidency of the EU from January to end June 2016. They will lead the Council’s negotiations in Trilogue discussions with the European Parliament and European Commission. The negotiations aim to produce one final compromise text each for the IVD and Medical Device regulations. Dutch representatives have been sitting in on the Trilogue since the negotiations started under the Luxembourg Presidency in October 2015 so they are already well aware of the key issues at stake and the amount of work they will need to get through.

Priority issues identified by the Dutch for Trilogue work include: genetic testing, companion diagnostics, chemicals, reprocessing, insurance, scrutiny/special notified bodies, transitional measures and the validity of certificates, classification (MD 6, 19, 21; IVD 1, 4, 5), and clinical investigations/performance studies IVD.

The Dutch Presidency stated that they aim to produce both the IVD and Medical Device compromise texts by the end of their presidency in June 2016. Once the final compromise texts are available, this could allow for a rapid second reading adoption by the European Parliament. In order to achieve their aim, the Presidency has announced that they will hold 3-5 political and 10-15 technical meetings by March 2016 on both texts. Following this intensive schedule of work they will conduct a review in March of their progress, and further identify outstanding issues and define plans moving forward.

EDMA and Eucomed will continue to follow and contribute to the Trilogue discussions.

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