Overview Of Medical Devices Regulation
The new Medical Devices Regulation (EU) 2017/745, and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 replace the three existing Directives (93/42/EEC, 98/79/EC, and 90/385/EEC) for medical devices.
Expertise
- Developing a clear Medical Device Regulation (MDR) implementation strategy
- Complete transition from MDD to MDR—from gap assessment through post-market surveillance, technical documentation including Design History File (DHF), and Risk Management File (RMF) preparation
- End-to-end support to develop Clinical Evaluation Report (CER)
- UDI implementation and consulting
- Risk management ISO 14971 consulting
Advantages
- Cost-effective
- End-to-end Regulatory consultation, including 510(k), 513(g), CER, MDR, IVDR, and PER
- Qualified team of experts with hands-on experience across all categories of Medical Devices
- Expert support for region-specific Regulatory complexities
- Interactions with Health Authorities (HAs)
- Structured approach to ensure quick product launch or market access
