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If your company does not have a physical location within the EU, European law for medical devices dictates that you must appoint a European Authorized Representative (or EC Rep) located in Europe to act as your liaison with the national Competent Authorities. We are an official EU Authorized Representative for hundreds of medical device manufacturers worldwide.
Why choose us as your European Authorized Representative?
- We are the largest Authorized Representative for medical devices and IVDs, representing more than 1,000 medical device companies worldwide.
We are a well-established business founded in 1997.
- 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.
- You will have secure online access to all of your documentation including Technical Files, Labeling Information and Symbols, Language Requirements, Directives, Guidelines, and more.
- We maintain offices throughout Europe, Asia, North and South America so we can serve you efficiently regardless of your time zone.
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.
Ask us about our special 3 year package for new European representation clients and read more about the benefits of hiring an independent firm to act as your EC REP in Europe.
Please contact us for more information on our European Authorized Representative services.