EU Medical Device Regulation - Operon Strategist

 

EU Medical Device Regulation (EU MDR) ensures high standards of quality and safety for medical devices being produced in or supplied into Europe. It is to have a fundamental revision in 2017 to better identify medical devices products and improve transparency through standard data, technological advances and the establishment of an EU database (Eudamed). 

Similar to the FDA’s UDI, EU Medical Device Regulation will establish a robust, transparent, predictable and sustainable regulatory framework for medical devices to ensure a high level of health and safety whilst supporting innovation. EU MDR is relevant to any organization producing or supplying medical device products to Europe.

• As CE mark consultants for medical devices we’ll help you for the process of making a defined technical file with all the product details.
• We will help you in meeting European submission standards that state the product offered is in compliance with the exact requirements of European safety.

EU Medical Device Regulation Benefits 

Until now, different European countries have interpreted and implemented the directive in different ways. By revising the directive EU Medical Device Regulation will enforce:

• Stricter pre-market control of high-risk devices at an EU level
• The inclusion of certain aesthetic products which present the same characteristics and risk profile as equivalent medical devices
• A new risk classification system for diagnostic medical devices based on international guidance
• Improved transparency through the establishment of a comprehensive EU database of medical devices (Eudamed)
• Device tractability through the supply chain from its manufacturer through to the final user
• An EU-wide requirement for an ‘implant card’ to be provided to patients containing information about implanted medical devices
• the reinforcement of the rules on clinical data and clinical studies on devices
• Manufacturers to collect data about the real-life use of their devices
• Improved coordination between EU Member States

The goal of these new regulations is to improve safety, quality and transparency for medical devices across the EU. Regulations for both the EU Medical Device Regulation and the IVDR will not become applicable right away. There is a transition period of three years for the MDR and five years for the IVDR. All medical device manufacturers and distributors will have to abide by the new regulations.

Read More - EU Medical Device Regulation

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Contact details –

Phone  no -  93702 83428

Mail id – enquiry@operonstrategist.com

If  You Want Medical Devices Services Consultation For Following.

1. Medical Device Consulting 
2. cdsco registration 
3. FDA 510k Clearance 
4. ce mark medical device 
5. CDSCO Manufacturing License 
6. CDSCO import license 
7. TURNKEY PROJECT CONSULTANT 
8. medical device manufacturing 
9. iso 15378 certification 
10. 21 cfr part 210 and 211 
11. ISO 13485 Medical Device Consultant 
12. Primary Packaging Turnkey Project Consultant 
13. Clean Room Design Consultant 
14. manufacturing site conceptualization 
15. Market Analysis and feasibility for Medical Devices 
16. manufacturing plant layout design 
17. medical device design and development 
18. DMF file submission guideline 
19. 21 cfr part 820 
20. qms certification services 
21. capa management 
22. design control requirements 
23. medical device process validation 
24. combination product 
25. continuous improvement program 
26. Medical Device Compliance & Regulatory Services 
27. Cdsco India authorized agent for medical device