The majority of medical devices intended for the European Economic Area (EEA) markets are governed by the requirements of the Medical Device Directive (MDD) 93/42/EC as amended (most recently via Directive 2007//47/EC). The MDD defines ‘authorised representative’ in Article 1.2(j) as meaning “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 14.2 defines the requirements thus: “Where a manufacturer who places a device on the market under his own name does not have a registered place of business in a Member State, he shall designate a single authorised representative in the European Union”. In simple terms this means that overseas manufacturers need to identify an EC authorized representative (EC REP), located in Europe, to undertake certain tasks and responsibilities.
What must the EC REP do? This is described in the MDD, are also elaborated more usefully in a MEDDEV guidance document (2.5/10 - January 2012). Herewith a summary – the EC REP:
As the intent of the EC REP requirement is the assurance of in-Europe support for these tasks, the onus on labeling text is quite precise. All product labeling (IFU’s, Packaging, promotional material etc.) is required to carry the name and address of the EC REP, in tandem with that of the Legal Manufacturer. Addresses must be real (no post boxes) and unambiguous in the detail provided. Labeling should also use the following symbology:
The EC REP is accountable to the NCA in the country of his / her residence. So, for example, all UK EC REP’s come under MHRA control.
Companies need to be mindful of the intent of the regulations, especially in regard to the EC REP execution of post market surveillance responsibilities. Of note also is a planned sharpening of focus for EC REP and other economic operators in the draft Medical Device Regulation (MDR). More on this topic anon.
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