EU Guidance On Periodic Safety Update Reports: Mixed Reactions
Executive Summary
Periodic safety update reports are a key feature of the EU’s Medical Device Regulation. New guidance is intended to support manufacturers in understanding these requirements. But there is some confusion over timelines.
You may also be interested in...
Global Medtech Guidance Tracker: December 2022
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-nine documents have been posted on the tracker since its last update.
EU Regulatory Experts Support Notified Bodies, But Argue For Greater Consistency
Notified bodies have been a pivotal part of the EU medtech regulatory system since it was first launched in the 1990s. Where might they fit within a new medtech regulatory governance structure? Panelists on a recent vodcast grappled with the question.
First Public Discussion On How EU Medtech Regulatory Governance Structure May Evolve
Does the EU need a medtech agency for the first time in its history? Nothing can or should be decided too quickly but five high-profile experts broadly agreed that change is now critical.