Your professional partner for the successful marketing of medical devices in Europe.
According to the European directives a European Authorized Representative has to be designated by a manufacturer of medical devices, in-vitro diagnostics and cosmetic products that is not located within the European Community. The specific tasks of the European Authorized Representative are described in the medical device directives MDD 93/42/EEC and AIMDD 90/385/EEC, the in-vitro diagnostic directive IVDD 98/79/EC and the cosmetic regulation 1223/2009.
Our Representation Services
MedNet - European Authorized Representative
Why MedNet EC-REP is your best choice?
- As your European Authorized Representative MedNet EC-REP acts as your legal entity towards the authorities while marketing your medical devices, active implantables, clinical studies or cosmetic products within the European Community, dealing with the obligations of the corresponding medical device directives.
- With our special experience in the complex European medical devices legislation, MedNet EC-REP provides fast study notifications and product registrations for medical devices, active implantables, in-vitro diagnostics and cosmetic products within the EU.
- Therefore our experts take care of the incident reporting and assist with the preparation of Declarations of Conformity as well as the application of several other Certificates.
What is a European Authorized Representative?
- A European Authorized Representative (EC Representative, EC Rep) acts as the legal entity of manufacturers outside of the European Community and fulfills the manufacturer’s obligations according to the relevant European directives.
- On behalf of the manufacturer the European Authorized Representative may deal with the European regulatory authorities regarding Declarations of Conformity, European labeling and language requirements, incident reporting, notification performance for clinical investigations, Free Sales Certificates or Certificates of Marketability as well as Certificates of product registration.
Why do I need an Authorized Representative in Europe?
- According to the European directives MDD 93/42/EEC, IVDD 98/79/EC, AIMDD 90/385/EEC and the cosmetic regulation 1223/2009 every manufacturer of medical devices, in-vitro diagnostics or cosmetic products outside of the European Community has to designate a European Authorized Representative.
What are the main duties of an EC Representative?
- The Authorized Representative performs product registrations or notifications into the relevant data bases of the European Countries and to the authorities in all EU Member States.
- When necessary, additional registrations are made in individual member states, i.e. Italian, Spanish or Portuguese registration.
- The European Representative assists manufacturers in all aspects of the necessary vigilance requirements such as incident reporting and acts as a contact point for authorities. All communication with the authorities is required to be done via the Authorized Representative.
Procedures after designating MedNet EC-REP as EC Representative
- The first step is for the manufacturer and the Authorized Representative to sign a legally binding document listing the duties and responsibilities of both sides. (Such a contract is usually required to obtain CE Marking).
- After signing the contract, the manufacturer issues all necessary documentation according to a check-list provided by MedNet.
- MedNet EC-REP - as your European Authorizes Representative - performs the product registration / notification according to the applicable directives to allow marketing and sales in the European Union.
- Thereafter, MedNet EC-REP can provide, upon request, necessary certificates of registration / notification.
Get in Touch with our Team
We are happy to assist you with more information about our European Representation Services.
+49 (0) 251 32266-64