How to tell them apart
In Europe, MDR almost always means the EU Medical Device Regulation (Regulation (EU) 2017/745). In the US, MDR usually means Medical Device Reporting under 21 CFR Part 803, the FDA system for reporting deaths, serious injuries and malfunctions. Check which jurisdiction the document is written for.
- Meaning 1 · RegulatoryEU Medical Device RegulationRegulation (EU) 2017/745 governing medical devices in the European Union.Read the full definition
- Meaning 2 · Post-MarketMedical Device Reporting (FDA)FDA mechanism for receiving reports of device-related deaths, serious injuries, and malfunctions.Read the full definition