Discussions on both the proposed in vitro diagnostic medical device and medical device regulations will continue into May as the Dutch Presidency focus on finalizing compromise positions by the end of this month, in view of reaching a political agreement at the EPSCO meeting on June 17. 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 May 11, 2016 (expected), are expected to include provisions for well-established products (for medical devices), genetic testing, clinical evidence, vigilance reporting and classification (for IVDs).
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