EU MDR Economic Operator

 

For the medical device manufacturer it is important to understand the role of EU MDR economic operator .These operators are also referred with the acronym MAID. The role of economic operator is tied to legal liability so one should understand how they fit in economic operator framework. 

Who are EU MDR economic operators?   

Economic operator As per MDR / IVDR economic operator means a manufacturer, an authorised representative, an importer, a distributor or the person referred to in Articles 22(1) and 22(3). The entities which supplies goods, services in context of that market is termed as operator. 

EU MDR Economic operators are considered as   

• Manufacturer  
• Authorised representative   
• Importer  
• Distributor  

As per article 22 (1) the entity that combines the devices which are CE Certified and   

• Devices that bear the CE marking  
• IVD medical devices bearing CE marking (EU IVDR 2017/746)  
• Compliant products used within a Medical Procedure or which presence on the pack is justified.  

Read More - EU MDR economic operator

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1. Orthopedic Implants Manufacturing

2. disposable syringe manufacturers

3. Dental Implants Manufacturing

4.Blood Collection Tubes Manufacturing

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