European Authorized Representation (EC REP)
Do you need an Authorized Representative?
If you are a medical device manufacturer that does not have a physical location within Europe, you must appoint an Authorized Representative (AR) and maintain the services of that representative for as long as you sell in the EU.
Several European CE Marking Directives spell out the need to appoint an Authorized Representative. They include:
- Medical Device Directive – 93/42/EEC
- In Vitro Diagnostic Device Directive – 90/385/EEC
- Active Implantable Medical Device Directive – 98/79/EC
The AR is a person/company that acts as a liaison between you and the EU Ministries of Health. The Directives outlined above also require that the AR maintain a copy of the manufacturer’s Technical File for review by Competent Authorities if required.
The list below shows some of the services provided by the AR:
- Authorisation to place its name, address, phone number on your device labels etc.
- Registration of the manufacturer and its products, with appropriate Competent Authorities.
- Represent the manufacturer in the case of a Competent Authority’s decision to refuse or restrict the placing on the market of a product or to require. withdrawal of a product from market.
- Act as a central point of contact point for the Competent Authorities and EU Commission.
- Keep available at the disposal of Competent Authorities and Notified Bodies, technical documentation, certifications and declarations of conformity.
- Review technical documentation for compliance, maintain and update documentation as required by the manufacturer.
- Incident reporting and products recalls.
- Responsibility for handling complaints and vigilance data arising from the marketing of the device.
- Assistance with Clinical investigation issues.
- Monitors and reports on new developments in European legislation.
Emergo Group is the ideal partner to act as your European Authorized Representative and will:
- Register the Company’s devices,if needed;
- Report incidents, complaints and other notifications to the relevant Competent Authority in accordance with your Quality Management System requirements and existing legislation;
- Be responsible for maintenance of the summary technical documentation on the device, and keep this available for EU Competent Authorities;
- Act as your contact point in the EU for communications from EU Notified Bodies and Competent Authorities;
- Provide guidance as to what events, incidents and complaints are reportable and copies of any medical device vigilance guidelines and documents that are appropriate.
Emergo Group is the ideal choice to be your Authorized Representative because:
- Our US and UK offices are always staffed which will enable any reportable event to be dealt with promptly;
- We can help you deal with any issue raised by any European Competent Authority
- Our team speaks several languages which will help with any correspondence and communication with a European Competent Authority.
Emergo Group is one of the largest Authorised Representatives for medical devices. You can see complete information on our primary website: AuthorizedRepresentative.com
