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The EC Authorised Representative

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:

  1. Registers its business details with the governing national competent authority (NCA).
  2. Lodges conformity assessment applications and makes declarations of conformity in certain circumstances at the behest of the Legal Manufacturer.
  3. Registers class I devices with the national Competent Authorities before they are marketed, where applicable.
  4. Acts as primary contact point for all National Competent Authorities, with full contact availability.
  5. Maintains access to Technical Files, Declarations of Conformity and other regulatory documents, such as to be available for inspection by the European Competent Authorities for the purpose of market surveillance.
  6. Maintains oversight of the supply chain “economic operators” for CE-marked products.
  7. Is responsible for incident reporting to the Competent Authorities and Notified Bodies in conjunction with the Legal Manufacturer and EEA Distributors.
  8. Represents the Legal Manufacturer to the European Commission for consultation in case of withdrawal of a medical device by a Member State.
  9. Notifies NCA’s of intent to carry out clinical studies in EEA Member States, and upon completion of said clinical studies, and maintains reports concerning the critical evaluation of all data collected during clinical evaluations for review by Competent Authorities.
  10. Reports any incidents resulting from said clinical studies to the relevant Competent Authorities.
  11. Reviews vigilance events and trends in line with expectations for post-market surveillance. 

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:

Manufacturer:

 b2ap3_thumbnail_manufacturer.png

Authorized representative in the European Community

b2ap3_thumbnail_ec-rep.png
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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John Leger has been married for 26 years and has six children.  He is a self-taught web developer who spends a lot of time learning new technologies and sharpening his skills.  His ability to learn new things quickly has enabled him to skillfully play the guitar, keyboard, flute and bass.  In his off time, he loves to hunt and ski.  He’s holds a black belt in classic Chung Do Kwon Taewkondo and is the lead instructor at Northshore Taekwondo Academy in his home town.

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