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European Authorized Representative (EC REP)
For medical device manufacturers that do not have a registered business presence within the European Union (EU), appointing a European Authorized Representative (EAR) is a legal requirement before their products can be placed on the EU market. The EAR acts as the manufacturerās official point of contact within the EU for all matters related to compliance with applicable legislation, including the EU Medical Device Regulation (EU MDR) 2017/745 and In Vitro Diagnostic Medical Device Regulation (EU IVDR) 2017/746. This role is critical because it ensures that the manufacturer meets all regulatory obligations despite being located outside the EU.
European Authorized Representative (EC REP) Services - Overview
Foreign Medical Device manufacturers who do not have a physical location in Europe must appoint a European Authorized Representative (EAR) based in any member countries of the European Union, who are a part of the countries recognizing CE mark. At Pharma wizard , we offer exceptional European Authorized Representative Services (EC REP) to support our clients at every step in their device registration process.
A European Authorized Representative (EAR) serves as a legal entity designated by non-European Union (EU) manufacturers, to represent them in the EU and ensure their compliance with EU MDR (2017/745) and/or IVDR (2017/746). They act as a point of contact between the non-EU manufacturer and the notified body, as well as national competent authorities.
A European Authorized Representative (EAR) serves as a legal entity designated by non-European Union (EU) manufacturers, to represent them in the EU and ensure their compliance with EU MDR (2017/745) and/or IVDR (2017/746). They act as a point of contact between the non-EU manufacturer and the notified body, as well as national competent authorities.
In addition, the European Authorized RepresentativeāÆ(EC REP) Services include:
- Device registration with national competent authority
- Verify manufacturerās Declaration of Conformity (DoC), technical documentation and CE Certificate
- Ensuring that an appropriate conformity assessment procedure has been carried out
- Keep available the copy of the Technical File, DoC and CE certificate including the supplements and amendments as applicable
- Communication with the EU competent authorities when required
- Confirming that Technical File Documentation is available for 10 years (Medical Devices) and 15 years (implantable devices) after the last device is placed in the market
- Support in incident and Field Safety Corrective Action (FSCA) reporting
- Represent the non-EU manufacturer in the EU,āÆ has its name and address on product labelling and other Regulatory documents
European Authorized Representative
- Expertise
- Advantages
- Independent representation and Regulatory support
- Continuous liaison with agency for submissions, queries and feedback
- Single point of contact in the country for liaison with Regulatory agency
- Cost-effective annual support for EC REP services
- Ensured Regulatory expertise outlook
- Qualified team of experts with hands-on experience across all categories of Medical Devices
- Support for region specific Regulatory complexities
- Extensive partner network across the member countries
