European (EU) Authorized Representative for Medical Devices and IVD
Do you want to market your medical device or IVD in Europe? If your company does not have a physical location within the EU, European law dictates that you must appoint a European Authorized Representative who is located within Europe to act as your liaison with the Competent Authorities. Emergo Europe is an official Authorized Representative for medical device manufacturers with physical offices located in The Hague, The Netherlands.
Why choose Emergo Europe as your European Authorized Representative?
- Emergo Europe, a subsidiary of Emergo Group, is one of the largest Authorized Representatives for medical devices, representing companies worldwide.
- We are a stable, ongoing business founded in 1997.
- Our familiarity with the European Competent Authorities allows us to promote the best interests of our clients.
- We are an ISO registered firm which includes Authorized Representation in the scope of our registration.
- We guarantee that your annual fee will NOT increase for three years.
- You will receive free updates and documents on European regulations for medical devices.
- You will have secure online access to all of your documentation including Technical Files, Labeling Info & Symbols, Language Requirements, Directives and more. This service is provided at no additional cost.
- We have a full service office in the United States and can serve you efficiently regardless of your time zone.
- We carry full liability insurance.
What does an EU Authorized Representative do?
- Registers your devices with the Authorities before they are marketed, if applicable.
- Acts as your primary contact point for all EU 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, address, telephone number on your device labels, packaging, Instructions for Use, etc.
- Always available to interact between you and the national Competent Authorities
- Responsible for Incident reporting to Competent Authorities, in cooperation with you and your distributors.
- Protects the confidentiality of your documentation. The European Authorized Representative can only show them to the Competent Authorities.
- Represents* you to the European Commission for consultation in case of withdrawal of a medical device by a Member State(s).
- Maintain reports concerning the critical evaluation of all data collected during clinical evaluations for review by Competent Authorities.
- Notify, or be notified by, the Competent Authorities of serious device incidents.
*Please note that additional consulting work beyond the scope of what is included in the Authorized Representative contract will require additional fees.
Can we appoint a distributor to act as our Authorized Representative for Europe?
Yes. However, there are several reasons why you should appoint an independent third party as your Authorized Representative instead:
- Your documents, labeling, manuals and other information must include your Authorized Representative 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 the distributor’s name on them.
- If you have multiple distributors of your products in the European marketplace, designating one of them as your Authorized Representative can create ill-will among the others.
- A conflict of interest may occur in the event of recall and/or incident reporting between you as the manufacturer and the distributor. If the Competent Authorities question an incident or a non-compliance that occurred in the distribution system, will your distributor defend their company or yours?
- The distributor should be focusing on sales and marketing, not on regulatory affairs. Will they keep you up-to-date on regulatory changes in Europe and provide timely warnings when changes affect your devices? Ignorance is not bliss.
- If you designate your distributor as your European Authorized Representative, they will have a full copy of your Technical File containing confidential design information. Can you afford the risk?
- Most distributors are not aware of the role of an Authorized Representative and the mandatory responsibilities that come with it.
Please contact us for a free consultation and no-obligation proposal on European Authorized Representative services.
Related services offered by Emergo Group:
- US Agent representation for FDA
- ISO 13485 quality system implementation or upgrade from ISO 13485:1996
- CE Marking consulting services for medical devices
Emergo Europe is a member of the
European Association of Authorised Representatives
