Navigating UK MDR Post‑Market Surveillance: Practical Differences from EU MDR and Actionable Morulaa Tips
The UK’s post‑Brexit amendments to post‑market surveillance (PMS) bring new expectations—especially for the Periodic Safety Update Report (PSUR). Much remains aligned with EU MDR 2017/745, yet several additions and modifications demand attention from regulatory and quality teams. Below, we outline the key UK‑specific changes—drawn entirely from the gap‑analysis PDF—and pair each with Morulaa Tips: practical pointers Morulaa’s MDR consultants use when […]