EU Medical Devices & IVD Regulations, MDR 2017/745 & IVDR 2017/746 Compliance
Latest Official Journal publications on Regulation (EU) 2017/745 (MDR) and 2017/746 (IVDR), transition timeline extensions, EUDAMED modules, and Notified Body designation acts.
Medical Devices & In Vitro Diagnostics Regulatory Landscape & Compliance Overview
Official IntelligencePolicyIndex indexes real-time gazette notifications, policy orders, tariff determinations, and compliance circulars issued across the Medical Devices & In Vitro Diagnostics sector. Regulatory intelligence is aggregated across central ministries, state regulatory commissions, and statutory authorities.
Statutory Directives
Official Extraordinary Gazettes, S.O. & G.S.R. orders, and executive notifications.
Compliance Mandates
Sector-specific regulatory obligations, licensing norms, and statutory filing guidelines.
Other Verticals in Healthcare, Pharmaceuticals & Life Sciences
Looking for Weekly Policy & Regulatory Briefings?
Access curated sector roundups, executive summaries, and downloadable PDF intelligence reports.
Official Medical Devices & In Vitro Diagnostics Gazettes & Notifications
Frequently Asked Questions on Medical Devices & In Vitro Diagnostics Regulations
What are the core requirements of EU MDR 2017/745?
The Medical Device Regulation (MDR) enforces rigorous clinical evaluation, Unique Device Identification (UDI) tracking, post-market surveillance (PMS), strict notified body oversight, and mandatory registration of economic operators and devices in EUDAMED.
What IVDR transition extensions has the EU enacted and why?
Regulation (EU) 2024/1860 extended the IVDR transition deadlines due to notified body capacity shortages, allowing class D IVDs certified under the old Directive 98/79/EC to remain on the market until 2027, class C until 2028, and class B/A sterile until 2029, with extended sell-off provisions.
What is EUDAMED and what modules does it comprise?
EUDAMED (European Database on Medical Devices) is the centralised IT platform mandated by MDR and IVDR, comprising six modules: Actor Registration, UDI/Device Registration, Notified Bodies and Certificates, Clinical Investigations, Vigilance and Post-Market Surveillance, and Market Surveillance, being deployed in phases.