Overview Of Medical Devices Regulation
The new Medical Devices Regulation (EU) 2017/745, and the new In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746. The Medical Devices Regulation (MDR) and in-vitro diagnostics regulation (IVDR) 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
- The 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 Of Medical Devices Regulation
- Cost-effective
- End-to-end Regulatory consultation, of 510(k) Submission Process Consulting, 513(g) Submission Process Consulting, Clinical Evaluation Report (CER), Medical Devices Regulation (MDR), In Vitro Diagnostic Regulation (IVDR) and Performance Evaluation Report (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
