Europe – MDCG’s 2020 Meetings to Tackle Clinical Data, Annex XVI, UDIs and More

As device firms ramp up their final preparations ahead of the 26 May application date for the Medical Devices Regulation (MDR), the European Commission’s Medical Device Coordination Group (MDCG) is planning to host 14 different meetings between now and then.

Kicking off the meetings is a workshop on 3 February on sufficient clinical data, which will likely be of interest to device firms because of the heightened requirements for providing such data for an increasing number of devices under MDR. The MDCG is also expected to release guidance on clinical evaluations sometime in 2020, as well as additional clinical guidance for legacy devices previously certified under the EU device directives.

Ten days after this first workshop, the MDCG will hold another workshop on periodic safety update reports (PSURs), which again, the MDCG says it’s planning to issue guidance on postmarket surveillance requirements…