A new amendment concerning the directive AIMDD 90/385/EEC for active implantable devices was published in the official journal of the European Union on September 21, 2007.
This amendment highlights the role and duty of the European Authorized Representative and states that “the authorized representative should [also] be available for any queries” (EU Member States Competent Authorities Amendment 19, Article 1, point 3 – Article 10a, paragraph 2, subparagraph 2 (AIMDD 90/385/EEC). In addition, the amendment highlights that the Authorized Representative should serve as a [vigilance] contact point with the EU member states competent authorities.
It is important for manufacturers to be aware of this amendment and other crucial points when appointing an authorized representative in Europe.
First, the European Authorized Representative cannot simply be a post office box but must be a registered place of business located within a European member states, or the European free trade area. When choosing an E.A.R. the manufacturer should look for a specialized and professional company as an E.A.R and it is not encouraged to use a distributor as an E.A.R., even if the distributor offers this service for free (http://www.obelis.net/Articles/
appointear.html). Appointing a Distributor may require him to make decisions contrary to his/her own interest and/or to your International sales objectives.
The following are the duties that an authorized representative in Europe is responsible for:
A European Authorized Representative has the responsibility to observe the manufacturer's compliance with the conformity assessment procedure set out in the European directives which apply to the product.
They exist to provide vigilance intervention; to handle and file the instance of any and all complaints and claims in regard to the manufactured product and are also responsible for observing the manufacturer's compliance with the conformity assessment procedure described in the European Directive for the product.
An E.A.R. must understand all EU regulations from each of the 27 EU member states EFTA.
They must keep the product’s technical file available at any time for the EU member states authorities and will handle the manufacturer's sensitive product information, trade secrets, European market information, distributor lists etc.
An E.A.R. must remain NEUTRAL in all actions and responsibilities towards all European Competent Authorities and if you are a manufacturer distributing in more then one EU country, the appointed European Authorized Representative would be aware of incidents in areas he is not responsible for.
If you are interested in appointing an E.A.R. and for more information on this topic please visit Obelis’ website at www.obelis.net.