EU Pilot On Device Incident Reporting: Lessons Learned And Next Steps
This article was originally published in SRA
Executive Summary
The European Commission’s Vigilance Working Group will decide next week whether or not to extend the EU pilot on medical device incident reporting. At a two-day meeting, on March 8-9, the working group will also consider the adoption of the revised EU Manufacturer Incident Report (MIR) form, which includes some recent adaptations.