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The European Authorized Representative for CE Certified Medical Devices Manufacturers
All Manufacturers of Medical Devices planning to export to European Union (EU) countries (now there are 25 countries in the Union) required obtaining CE marking for their Products.
CE marking for Medical Devices is guided by the Medical Device Directive MDD/93/42 (The same is under revision and draft is under circulation).
There are various classifications under the directive (see separate article on classification of Medical Devices under MDD/93/42) (A separate article for In-Vitro Diagnostic Devices is under preparation and will be published in subsequent issues of this magazine).
For each classification various separate and common requirements need to be fulfilled to obtain CE marking for the Medical Devices to be exported.
One important requirement for non-European medical device manufacturers and exporters to EU countries is appointing an Authorized European Union Representative. The name and address of E.A.R. appears on all the Device labels.
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.
Authorized Representative may be an agent, distributor, or independent Authorized Representative based in EU Countries.
The European Authorized Representative (E.A.R.) can be from any of above but consider the following:
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Do you want your distributor to focus on sales & marketing or on regulatory affairs?
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Will your distributor in country an object if the name and address of your distributor in country B appears on all devices, inserts and packaging?
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Will it lead to distribution/warranty confusion if the name and address of distributor A appears on your devices in all EU States?
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If you change distributors will it be costly to change all device labels, inserts and packaging?
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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.
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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?
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If your distributor is unable to answer the Competent Authority’s questions does anyone in your company have the knowledge to do so directly?
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Are you comfortable placing a technical file containing design information with your distributor?
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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?
From above we can see that an independent European Authorized Representative is the best choice. Further E.A.R. does not sell Devices and hence they do not compete with your distributors and/or agent.
Selection of European Authorized Representative (E.A.R.) is an important step. Authorized Representative should be experienced and well versed in the areas of Medical Devices and related directives.
An agreement is drawn between the Device Exporter and E.A.R. outlining the essential duties of the Authorized Representative in accordance with the requirements in the Medical Device Directive.
(In the next
issue, we shall discuss in more details the essential duties of E.A.R. and also important issues related to the agreement with EU Authorised representative.)
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