European Authorized Representative for Medical Devices and IVDs
“We are glad to have found a partnet that really values our PR style customer oriented, and we appreciate him for dealing with us the same way.”
“The collaboration with you really open the European market to us. Thank you for helping us translating the user manual. Would have been very dfficult to find a translator for texts that are such technical.”
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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 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 one of the youngest companies in this new market and act as an Authorized Representatives for medical devices and IVDs, representing hundreds of medical device companies worldwide.
- We have relations with well-established businesses around the Globe.
- Our experts are familiar with the European regulatory environment and frequently dealing with Competent Authorities allows us to promote the best interests of our customers..
- We provide regularly updates on European regulations for medical devices so the new legislation changes find our customers prepared.
- 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 business relations with the European medical device retailers and promote your products to them.
What is the role of an EU Authorized Representative?
- Registers your devices with the national Competent Authorities before they are marketed, folowing the mandatory registration procedure.
- Acts as your primary contact point for all national Competent Authorities, importers, retailers and local buyers.
- Maintains a copy and protects the confidentiality of your Technical Documentation available for inspection by the European Competent Authorities. The European Authorized Representative can only show technical documentation to Competent Authorities as required by law.
- Our experience as Authorized Representatives for medical devices and IVDs gives us the ability to mediate eficiently 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.
- Represents you to the European Commission for consultation in case of withdrawal of a medical device by a Member State(s).
- Maintains and regularly updates to you the 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.
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