FREQUENTLY ASKED QUESTIONS ABOUT THE ROLE OF THE EUROPEAN AUTHORIZED REPRESENTATIVE FOR NON-EU MANUFACTURERS OF MEDICAL DEVICES.
1) Why do we need to select an Authorized Representative, if we are located outside Europe?
For Risk Class I devices it is the law and for all other risk classifications a requirement by most of the certifying agencies called Notified Bodies.
2) What are our options?
You may select an agent, distributor, or independent Authorized Representative.
3) How do we choose between an agent, distributor and an independent Authorized Representative?
Consider the following:
Do you want your distributor to focus on sales & marketing or on regulatory affairs?
Will your distributor in country A object if the name and address of your distributor in country B appears on all devices, inserts and packaging?
Will it lead to distribution/warranty confusion if the name and address of distributor A appears on your devices in all EU States?
If you change distributors will it be costly to change all device labels, inserts and packaging?
Do you feel comfortable having your distributor represent you in front of the Competent Authorities? The Competent Authority is the equivalent to the FDA in the USA.
If the Competent Authorities question an accident or a non-compliance that occurred in the distribution system will your distributor defend his company or yours?
If your distributor is unable to answer the Competent Authority's questions does anyone in your company have the knowledge to do so directly?
Are you comfortable placing a technical file containing design information with your distributor?
Do you feel that your distributor stays up to date on regulatory changes in Europe and will provide you with timely warning when changes affect your devices?
4) Do independent Authorized Representatives sell medical devices in Europe?
No, they do not sell products; they do not compete with your distributors and/or agent.
5) How do we select an Authorized Representative?
First you choose an Authorized Representative that is experienced and well versed in the areas of Medical Devices and related directives. Then you draw up an agreement clearly outlining the essential duties of the Authorized Representative in accordance with the requirements in the Medical Device Directive.
6) Which of the Authorized Representative's essential duties are listed in the Medical Device Directive and what should we ask for in addition?
Essential Duties required by Law:
Authorization to place its name, address, phone number on your device labels etc.
Acting as your primary contact point for the EU Authorities.
Registering of your Risk Class I devices with the Authorities before they are marketed.
Keeping your technical file documentation ready and available for the European Competent Authorities.
Protecting your documentation confidentiality because they are authorized to show them to the Competent Authorities only.
Notification of serious device incidents to the Competent Authorities
Additional services you should ask for:
Assistance with technical file documentation including examples of procedures
Simplification of the Risk Analysis
Co-signing of the Declaration of Conformity
Annual review of your technical file
On-site visits
Notification of changes and amendments to the Medical Device Directive that affect your device(s).
7) Why should the Authorized Representative sign the manufacturer's Declaration of Conformity?
The Declaration of Conformity clarifies who the European Authorized Representative is to any distributor, agent or other interested party.
8) What does the Authorized Representative expect from us, the manufacturer?
Device compliance with the Medical Device Directive requirements.
Placing of your technical documentation in its trust.
Immediate notification of device incidents.
Full cooperation with requests from the Competent Authorities
Product Liability Insurance coverage that includes the EU.
Indemnification of product liability.
9) Why do we need to place a partial technical file with our Authorized Representative in Europe?
To enable the Authorized Representative to respond to inquiries from the Competent Authorities within an allocated time period.
10) How do we keep this technical file up to date?
An Authorized Representative should, at a minimum, provide you with an annual review of your technical file and remind you what to update. You should have access to your documentation in Europe when traveling for a personal review. Your Authorized Representative should visit your facility at regular intervals and assist you with the update.
11) Is all the information that we place with the Authorized Representative confidential?
Confidentiality should be covered in the agreement between your company and the Authorized Representative in accordance with the Medical Device Directive which states that all parties, authorities included, are bound to observe confidentiality with regard to all information.
12) What are the Authorized Representative's obligations and liabilities if the manufacturer's devices are
not in compliance?
The Authorized Representative and the manufacturer are both obliged to end the infringement under conditions imposed by the member state such as: a letter of warning, penalty, sales ban etc.. Plus the producer i.e. manufacturer and other entity placing its name on the device, is liable for damages caused by defect devices. This is outlined in the product liability directive.
13) Is product liability covered by the Authorized Representative agreement?
The product liability directive refers to any entity placing its name on the device. The medical device directive requires that the manufacturer plus the Authorized Representative names be printed on the device label, with the result that both parties are held liable. To prevent duplication of liability insurance for the same device the Authorized Representative becomes an additional insured under the manufacturer's worldwide policy.
14) Why do Authorized Representative agreements include a penalty clause in case of a contractual
violation by the manufacturer?
The Authorized Representative is subject to EU law. The device manufacturer however resides outside the EU Legal Jurisdiction and may decide not to cooperate with the EU authorities. To minimize the Authorized Representative's exposure of being on the receiving end of a manufacturer's liabilities, the penalty clauses provide recourse.
15) If we cancel our Authorized Representative agreement do all duties stop immediately?
No, the Authorized Representative's name remains on devices already sold and still in use, resulting in the continuation of some obligations even after cancellation of the agreement.