The European Commission’s Medical Device Coordination Group published guidance 13/05/2020 on reporting safety events involving investigational devices under the incoming regulations.
The document said sponsors will use a new template to file safety reports in the period between the Medical Device Regulation coming into force and the linked Eudamed database going live.
In a separate update this week, the EC laid out the current status of ongoing guidance development within MDCG subgroups on more than 40 topics related to MDR, IVDR, or both. Of the many deliverables slated for MDCG endorsement in 2020, two relate to Eudamed: a guidance on harmonized administrative practices and alternative technical solutions, and a position paper on the use of SRN (single registration number).