Authorized Representative Requirement
What is an Authorized Representative? When is an Authorized Representative required?
An Authorized Representative represents a medical device manufacturer on all issues of law and regulation and compliance to all Competent Authorities in the EU and EFTA countries and before the European Commission. An Authorized Representative is required whenever a manufacturer does not maintain a legal residence within the EU or EFTA countries.
DIRECTIVE 98/79/EC
(18 June 2009)
Article 1
Definitions, scope
(f) ‘manufacturer’ means the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party.
The obligations of this Directive to be met by manufacturers also apply to the natural or legal person who assembles, packages, processes, fully refurbishes and/or labels one or more ready-made products and/or assigns to them their intended purpose as devices with a view to their being placed on the market under his own name. This subparagraph does not apply to the person who, while not a manufacturer within the meaning of the first subparagraph, assembles or adapts devicesalready on the market to their intended purpose for an individual patient;
(g) ‘authorised representative’ 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;
Article 10
Registration of manufacturers and devices
1. Any manufacturer who places devices on the market under his own name shall notify the competent authorities of the Member State in which he has his registered place of business:
- of the address of the registered place of business,
- of information relating to the reagents, reagent products and calibration and control materials in terms of common technological characteristics and/or analytes and of any significant change thereto including discontinuation of placing on the market; for other devices, the appropriate indications,
- in the case of devices covered by Annex II and of devices for self-testing, of all data allowing for identification of such devices, the analytical and, where appropriate, diagnostic parameters as referred to in Annex I, part A, section 3, the outcome of performance evaluation pursuant to Annex VIII, certificates and any significant change thereto, including discontinuation of placing on the market.
2. For devices covered by Annex II and for devices for self-testing, Member States may request to be informed of the data allowing identification together with the label and the instructions for use when such devices are placed on the market and/or put into service within their territory.
These measures cannot constitute a precondition for the placing on the market and/or putting into service of devices which are in conformity with this Directive.
3. Where a manufacturer who places devices on the market under his own name does not have a registered place of business in a Member State, he shall designate an authorised representative. The authorised representative shall notify the competent authorities of the Member State in which he has his registered place of business of all particulars as referred to in paragraph 1.
4. The notification referred to in paragraph 1 shall also include any new device. In addition, where, in the context of such notification, a device notified, bearing the CE marking, is a ‘new product’, the manufacturer shall indicate this fact on his notification.
For the purposes of this Article, a device is ‘new’ if:
(a) there has been no such device continuously available on the Community market during the previous three years for the relevant analyte or other parameter;
(b) the procedure involves analytical technology not continuously used in connection with a given analyte or other parameter on the Community market during the previous three years.
5. Member States shall take all necessary measures to ensure that the notifications referred to in paragraphs 1 and 3 are registered immediately in the databank described in Article 12.
The procedures for implementing this Article and in particular those referring to the notification and the concept of significant change shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).
6. Transitionally, pending the establishment of a European databank accessible to the competent authorities of the Member States and containing the data relating to all devices available on the territory of the Community, the manufacturer shall give such notification to the competent authorities of each Member State concerned by the placing on the market.