European Authorized Representative FAQs
European Authorized Representative
A European Authorized Representative (E.A.R.) serves as a legal entity designated by non-European Union (EU) manufacturers, to represent them in the EU and ensure their compliance with the European Directives. Authorized Representative should serve as a contact point with the EU member states competent authorities. Medical Device Regulation (MDR) and in vitro diagnostic Medical Device Regulation ([Regulation_(EU)_2017/746]) increases obligations of E.A.R in the field of surveillance of medical devices.
European Authorized Representative for Medical Device
Whether a medical device requires a Notified Body (in the case of Class I sterile/measuring/ resusable or IIa, IIb, III) in order to obtain the CE Marking or is permitted to self-declare (Class I non-sterile, non-measuring), non-EU based manufacturers are legally obligated to appoint an Authorized Representative in order for their products to legally circulate within the EU Market.
EU Authorized representative services
A European Authorized Representative may also be known as a EUAR, EC REP, CE REP, EU REP and also an EAR. All of these mean the same; EU Authorized Representative.Your European Authorized Representative (EC Rep) provides a point of contact between you (the non-European medical device manufacturer) the national Competent Authorities (Ministry of Health) and Notified Bodies.
European Authorized Representative requirements
To become an EU Authorized Representative of a company there are 2 main obligations:Being a natural or legal person established in the European Economic Area (EEA), European Union (EU) & European Free Trade Association (EFTA). You should be explicitly designated (Authorized) by a non-European manufacturer with a written mandate And most importantly you should accept to be the Representative of this company.
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Contact details –
Phone no - 93702 83428
Mail id – enquiry@operonstrategist.com
Phone no - 93702 83428
Mail id – enquiry@operonstrategist.com
- Medical Device Consulting
- cdsco registration
- FDA 510k Clearance
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- CDSCO Manufacturing License
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- TURNKEY PROJECT CONSULTANT
- medical device manufacturing
- iso 15378 certification
- 21 cfr part 210 and 211
- ISO 13485 Medical Device Consultant
- Primary Packaging Turnkey Project Consultant
- Clean Room Design Consultant
- manufacturing site conceptualization
- Market Analysis and feasibility for Medical Devices
- manufacturing plant layout design
- medical device design and development
- DMF file submission guideline
- 21 cfr part 820
- qms certification services
- capa management
- design control requirements
- medical device process validation
- combination product
- continuous improvement program
- Medical Device Compliance & Regulatory Services
- Cdsco India authorized agent for medical device
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