EU Authorized Representative Introduction
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 who is located within Europe to act as your liaison with the national Competent Authorities. Emergo Europe is an official EU Authorized Representative for hundreds of medical device manufacturers worldwide, with offices located in The Netherlands.
Why you should NOT appoint a distributor as your in-country representative:
In the rush to introduce a new product, many companies give little thought to the appointment of their in-country regulatory representative and appoint a distributor to fulfill this important role. This can be a costly mistake.
1. In markets such as Japan, Australia, Mexico, Brazil and China, the in-country regulatory representative controls the device approval and/or device registration. If you appoint a distributor to this role instead of an independent regulatory representative, switching distributors becomes extremely difficult and may require starting the device approval process all over again if your distributor is not willing to cooperate. This can be extremely expensive as you would not be able to sell in the market until re-registration is completed. You would also be required to pay a new registration fee.
2. In many markets your technical documentation, labeling, manuals and other information must include your in-country representative's name and address. If you elect to use a distributor and then decide to switch distributors, you will need to reprint labels, manuals, and deal with the issue of products already in the marketplace with that distributor's name on them. Plus, distributors do not like to see other distributors names on your labeling.
3. Most distributors are not aware of the role of an in-country representative and the mandatory responsibilities that come with it and often elect to take on this responsibility to maintain control over your device on the market from a commercial point of view.
4. A conflict of interest may occur in the event of recall and/or incident reporting between you (the manufacturer) and the distributor. If the regulatory authorities question an incident or a non-compliance that occurred in the distribution system, will your distributor defend their company or yours?
5. The distributor is focused on sales and marketing, not on regulatory affairs. They may not keep you up-to-date on regulatory changes in the market and provide timely warnings when changes affect your devices.
Our EU Representative Services Include:
1) Acts as your primary contact point for all national Competent Authorities.
2) Maintains a current copy of your Technical File available for inspection by the European Competent Authorities.
3) Gives you authorization to place our name and address on your device labels, packaging and Instructions for Use.
4) Always available to interact between you and the national Competent Authorities.
5) Responsible for Incident reporting to Competent Authorities, in cooperation with you and your distributors.
6) Protects the confidentiality of your documentation. The European Authorized Representative can only show technical documentation to Competent Authorities as required by law.
7) Represents you to the European Commission for consultation in case of withdrawal of a medical device by a Member State(s).
8) Maintains reports concerning the critical evaluation of all data collected during clinical evaluations for review by Competent Authorities.
9) Notifies or is notified by, the Competent Authorities of serious device incidents.