E.C. Authorized Representative
European Medical Device Directive ,93/42/EEC, defineds E.C . representative as below.
means any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter’s obligations under this Directive;
According to the GUIDELINE FOR AUTHORISED REPRESENTATIVES – MEDDEV 2.5/10, the appointment of an authorised representative does not change the responsibilities of the manufacturer. The authorised representative must be duly selected and supervised by the manufacturer.
As the directives do not include a detailed description of the role and obligations of an authorised representative it will be of vital importance to both the manufacturer and the authorised representative to set up a contract specifying the task and authority the manufacturer will delegate to the authorised representatives, also where the authorised representative is a daughter company of the manufacturer established outside the EU.
However, in some Member States the authorised representative will have responsibilities directly under national law. For instance he might have the responsibility to ensure that the appropriate conformity assessment procedure has been carried out, that the device is properly CE marked and that information is provided in a specified national language. Another example may be that the authorised representative must have a vigilance system in place which is compatible with that of the manufacturer. An authorised representative must therefore be fully informed about the legal obligations included in the national legislation of the Member State in which he has his residence / where devices are placed on the market. Those “national” obligations should be reflected in the above mentioned contract with the manufacturer.
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 requires Authorised representatives shall have available within their organisation at least one qualified person who possesses expert knowledge regarding the regulatory requirements for medical devices in the Union. The expert knowledge shall be demonstrated by either of the following qualifications:
(a) a diploma, certificate or other evidence of formal qualification awarded on completion of a university degree or of an equivalent course of study, in law, natural sciences, medicine, pharmacy, engineering or another relevant discipline, and at least two years of professional experience in regulatory affairs or in quality management systems relating to medical devices;
(b) five years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
Hence, if you have made E.C. Authorized Representative contract with a unprofessional person and/or organization, this is a good time to look for another one.
Wise Co., Inc. is providing E.C. Authorized Representative with a partner, JaviTech e.k. located in Germany. Our E.C. Authorized Representative has years of experience and qualification required by come MDR.
Please Contact us for any further question.