EC’s Medical Device Coordination Group Issues Guidance on Safety Reporting

The European Commission’s Medical Device Coordination Group (MDCG) has outlined in a new guidance how devicemakers should report safety incidents for clinical studies under the EU’s new MDR.

Under the new MDR, sponsors must report to all EU member states as quickly as possible any serious adverse event linked to an investigational device, the MDCG said.

They must also report any device deficiency that might have led to a serious adverse event if appropriate action had not been taken, the group said.