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.