MDR (Devices)

Medical Device Reporting / EU Medical Device Regulation

The acronym collides, and the two meanings are not related — so context matters. In the US, Medical Device Reporting under 21 CFR Part 803 is a post-market vigilance obligation: manufacturers, importers, and user facilities must tell FDA when a device may have caused or contributed to a death or serious injury, or has malfunctioned in a way that would likely cause such an outcome if it recurred. Manufacturer reports are generally due within 30 calendar days, or 5 working days where remedial action is needed to prevent an unreasonable risk of substantial harm.

In the EU, the MDR is Regulation (EU) 2017/745 — the entire regulatory framework for medical devices, which replaced the old Medical Device Directive and applied from 26 May 2021. It is far broader than reporting: classification rules, conformity assessment through Notified Bodies, clinical evaluation, UDI, EUDAMED registration, post-market surveillance plans, and periodic safety update reports.

The EU’s equivalent of US MDR sits inside that framework as vigilance (Articles 87–92), and its clocks are tighter: serious incidents must be reported no later than 15 days, dropping to 10 days for a death or unanticipated serious deterioration in health, and 2 days where there is a serious public health threat. Field safety corrective actions are notifiable in their own right. A manufacturer selling in both markets runs both systems against different definitions and different deadlines.

• —US MDR = Medical Device Reporting (21 CFR 803), a post-market reporting duty.
• —EU MDR = Regulation (EU) 2017/745, the whole device framework — applied 26 May 2021.
• —US clocks: 30 calendar days generally; 5 working days where remedial action prevents unreasonable risk.
• —EU vigilance clocks: 15 days for serious incidents; 10 days for death or unanticipated serious deterioration; 2 days for a serious public health threat.
• —EU MDR also brings Notified Body assessment, clinical evaluation, UDI, EUDAMED, PMS and PSURs.
• —Selling in both markets means running two systems with different definitions and deadlines.

US: 21 CFR Part 803 (Medical Device Reporting), alongside 21 CFR Part 820 / the FDA QMSR. EU: Regulation (EU) 2017/745 (MDR), vigilance under Articles 87–92; Regulation (EU) 2017/746 (IVDR) is the in-vitro diagnostic counterpart.