Medical device and IVD trilogue discussions

Posted on 04.05.2016

Discussions on both the proposed in vitro diagnostic medical device and medical device regulations will continue into May as the Dutch Presidency focus on finalising compromise positions by the end of this month, in view of reaching a political agreement at the EPSCO meeting on 17 June.  Should compromise texts be agreed, a final adoption and publication of the Regulations could be expected as early as Q4 of 2016.

Topics for the next trilogue meeting on 11 May 2016 (expected), are expected to include provisions for well-established products (for medical devices), genetic testing, clinical evidence, vigilance reporting and classification (for IVDs).

EDMA and Eucomed will continue to follow closely the discussions towards reaching agreement on the proposed regulations.