Designation of an authorised representative

A manufacturer who places a medical device on the market must designate “a single authorised representative in the European Union” if he does not have a registered place of business in EU (AIMDD Art 10a(2), MDD Art 14(2)). The same request is made by IVDD Art 10(3), though without the inclusion of the specification “single”

As clarified in Recital 14 of Directive 2007/47/EC, an authorised representative must be the single authorized representative within EU for at least all devices of the same type. A manufacturer may have different authorized representatives for different devices (types). The requirement to have an authorised representative is applicable to all medical devices placed on the Community market, where the manufacturer is based outside of the EU. The requirement to have an authorised representative is also applicable to devices intended for clinical investigation (MDD, AIMDD) or performance evaluation (IVDD) within the Community market, where the manufacturer is based outside of the EU.

MDD - Medical Devices Directive 93/42/EEC (as amended by Directive 2007/47/EC) 

AIMDD- Active Implantable Medical Devices Directive 90/385/EEC (as amended by Directive 2007/47/EC) 

IVDD - InVitro Diagnostic Medical Devices Directive 98/79/EC

In addition to the requirements described hereunder, there may be specific national notification requirements, which are incumbent to the manufacturer, but which can be delegated to the authorised representative. 

MDD i AIMDD

Registration of the authorised representatives, manufacturers and devices

An authorised representatives designated for a device covered by the obligation to notify the Competent Authorities (MDD class I, procedure packs and custom made devices and AIMDD custom made devices) is obliged to register with the competent authority of the member state in which he is located and to inform the Competent Authorities of the address of the registered place of business of the manufacturer and the description of the devices concerned (AIMDD Art 10a, MDD Art 14). 

Registration of the authorised representatives, manufacturers and devices

An authorised representatives designated for a device covered by the obligation to notify the Competent Authorities (MDD class I, procedure packs and custom made devices and AIMDD custom made devices) is obliged to register with the competent authority of the member state in which he is located and to inform the Competent Authorities of the address of the registered place of business of the manufacturer and the description of the devices concerned (AIMDD Art 10a, MDD Art 14). 

IVDD

Registration of the authorised representatives, manufacturers, devices and certificates

An authorised representative designated for a device covered by the IVDD is required to register with the competent authority of the Member State in which he is located and to inform the Competent Authorities of the address of the registered place of business of the manufacturer, and to provide information related to the devices, and to the certificates (Art 10). 

Registration of performance evaluations

A manufacturer who does not have a registered place of business in a Member State of the EU, and who wants to undertake a performance evaluation of a diagnostic 6/17 device, within these territories, must appoint an authorised representative. The authorised representative will communicate the information on the manufacturer and on the device to the Competent Authorities of the Member State in which he has his registered place of business. The declaration required for devices for performance evaluation (IVDD Annex VIII) is drawn up by the manufacturer or the authorised representative

The Directive enables a manufacturer to delegate the performance of certain requirements of the Directive to his designated authorized representative. This should be specifically taken on board in the contract between the manufacturer and the authorized representative.

MDD

Art 11(8): The manufacturer may instruct his authorized representative to initiate the procedures provided for in Annexes III, IV, VII and VIII. - Lodge a conformity assessment application for EC type-examination (Annex III), - Establish the declaration of conformity to the type described in the EC typeexamination certificate (EC Verification: Annex IV), - Establish the Annex VII EC declaration of conformity, including Annex VII Section 5 in case of products placed on the market in sterile condition and Class I devices with a measuring function, - Establish the statement for custom-made devices (Annex VIII Section 2.1).

AIMDD

Art 9.3.: Where appropriate, the procedures provided for in Annexes 3, 4 and 6 may be discharged by the manufacturer's authorized representative established in the Community. - Lodge a conformity assessment application for EC type-examination (Annex III), - Establish the declaration of conformity to the type described in the EC typeexamination certificate (EC Verification: Annex IV), - Establish the statement for custom-made devices (Annex VI Section 2.1).

IVDD

Art 9.6.: The manufacturer may instruct his authorised representative to initiate the procedures provided for in Annexes III, V, VI and VIII. - Establish the Annex III EC declaration of conformity, - Lodge a conformity assessment application for EC type-examination (Annex V), - Establish the declaration of conformity to the type described in the EC typeexamination certificate (EC Verification: Annex VI). 

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