European Authorized Representative
According to European law for medical devices, companies that do not have a physical location in the EU must appoint a European Authorized Representative who is located within Europe.
Methodize Inc. can provide your company with an official EU Authorized Representative that will act as your liaison with the national Competent Authorities. With offices in the Netherlands, Methodize Inc. will represent your company within the European Commission and to the National Competent Authorities.
Appointing Methodize Inc., as your European Representative will effectively ensure your company's compliance with the European Medical Devices Directives (Medical Device Directive 93/42/EEC; Active Implantable Medical Devices 90/385/EEC; and, In Vitro Diagnostic Medical Device Directive 98/79/EEC).
As your European Authorized Representative, Methodize Inc. will:
- Act as your primary contact point for all national Competent Authorities
- Maintain a current copy of your Technical File available for inspection by the European Competent Authorities.
- Register your devices with the national Competent Authorities before they are marketed, where applicable (for example, Class I devices).
- Give you authorization to place our name and address (Methodize Europe) on your device labels, packaging and Instructions for Use.
- Report to Incident and Field Safety Corrective Action (FSCA) and to Competent Authorities, in cooperation with you and your distributors.
- Represent your company to the European Commission for consultation in case of withdrawal of a medical device by a Member State(s).
- Protect the confidentiality of your documentation.
- Communicate with the Competent Authorities regarding serious device incidents or FSCA.