The Importance of Being Authorized*
Dr. Maria E. Donawa
ABSTRACT
MDD 93/42/EEC stipulates most clearly, the necessity for
appointing an ‘Authorized Representative’. (Article 14.2, Annex 1 - essential
requirements and Annex VII - EC Declaration of Conformity). The Author discusses the
concept behind appointing an ‘Authorized Representative’ and what the medical
device manufacturer MUST bear in mind, BEFORE announcing such an appointment.
The article discusses the role of the authorized
representative, as specified in the published Directives and as defined in the proposed
European Directive on in vitro diagnostic medical devices.
- "Medical device companies located outside the
European Economic Area(EEA) and without subsidiaries in the EEA, will need to designate
authorized representatives to perform certain duties under the European medical device
Directives. The duties and responsibilities of those representatives, should be clearly
understood by medical device companies and prospective authorized representatives BEFORE
any designation contract is signed".
- "it is clear, that manufacturers designating
authorized representatives, should do so in writing and carefully define all assigned
duties and responsibilities. Also, it is important to distinguish between the regulatory
role of the authorized representative and the role of persons or entities responsible for
marketing or importing devices into the EEA".
- "the manufacturer may instruct his authorized
representative established in the Community, to initiate the procedures for EC
Type-Examination, EC Verification, EC Declaration of Conformity (Class I and Class IIa
devices)."
- "…the Competent Authorities in charge of market
surveillance must be able, particularly in emergencies, to contact the manufacturer or his
authorized representative established in the Community…".
- "the label, or the outer packaging, or instructions
for use, shall contain in addition the name and address of either the person responsible
referred to in Article 14(2) or of the authorized representative of the manufacturer
established within the Community".
- "Manufacturers should be careful to designate only
those authorized representatives who are qualified to represent the manufacturer’s
interests in the EEA with regard to the Directives. That is, authorized representatives
need to be able to effectively carry out the procedures that they are designated to carry
out and to understand the regulatory significance of representing the manufacturer to
Competent Authorities and/or Notified Bodies. Also, manufacturers should maintain copies
of all relevant documents and correspondence, so that they are fully aware of their
compliance with the Directives at all times".
©copyright April 1996, Medical Device Technology, by: Maria E. Donowa
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