If your company does not have a physical location in the EU, we are an official EU Authorized Representative of hundreds of medical device manufacturers worldwide.

CMC Medical Devices as your European Authorized Representative

• We are one of the largest Authorized Representatives for medical devices and IVDs, representing hundreds of medical device companies worldwide.
• Our familiarity with the European regulatory environment and Competent Authorities allows us to promote the best interests of our clients.
• We are an ISO registered firm which includes European Authorized Representation in the scope of our registration.
• You will receive free updates on European regulations for medical devices.

What is the role of an EU Authorized Representative?

• Registers your devices with the national Competent Authorities before they are marketed, where applicable.
• Acts as your primary contact point for all national Competent Authorities.
• Maintains a current copy of your Technical File available for inspection by the European Competent Authorities.
• Gives you authorization to place our name and address on your device labels, packaging and Instructions for Use.
• Always available to interact between you and the national Competent Authorities.
• Responsible for Incident and Field Safety Corrective Action (FSCA) reporting to Competent Authorities, in cooperation with you and your distributors.
• Protects the confidentiality of your documentation. The European Authorized Representative can only show technical documentation to Competent Authorities as required by law.
• Represents you to the European Commission for consultation in case of withdrawal of a medical device by a Member State(s).
• Maintains reports concerning the critical evaluation of all data collected during clinical evaluations for review by Competent Authorities.
• Notifies or is notified by the Competent Authorities of serious device incidents or FSCA.