EU Services for Medical Devices

If you need an EU Authorised Representativecontact us

• Fast product registrations to the EU Competent Authorities
• Guidance in the preparation of Declarations of Conformity
• Guidance in the labelling and language requirements in Europe
• Incident reporting to the Competent Authorities according to the local legal requirements and MEDDEV guidelines in each EU Member state
• Notification services for clinical investigations
• Application of Free Sales Certificates or Certificates of Marketability
• Provision of Certificates of product registration

What is the need of the EC - REP?

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 Authorised Representative.

What is a European Authorised Representative?

• A European Authorised Representative (EC Representative, EC Rep) acts as the legal entity of manufacturers outside of the European Community and fulfils the manufacturer's obligations according to the relevant European directives.
• On behalf of the manufacturer the European Authorised Representative may deal with the European regulatory authorities regarding Declarations of Conformity, European labelling and language requirements, incident reporting, notification performance for clinical investigations, Free Sales Certificates or Certificates of Marketability as well as Certificates of product registration.