Fabian Demicoli

Medical Devices-Labelling requirements

 The EU Competent Authorities for the Directives on medical devices have reached an agreement on a harmonized approach in the interpretation of the following legal provision: "The label must bear the following particulars: the name or trade name and address of the manufacturer. For devices imported into the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of the authorised representative where the manufacturer does not have a registered place of business in the Community."

Harmonization, particularly the achievement of a coherent interpretation of legal rules and the scope of those requirements, is an important part of the market surveillance system.

In September 2010 the Competent Authorities in the medical devices sector established the Central Management Committee (CMC) to support and improve a harmonised implementation of the regulatory system. On June 7, 2011 CMC issued a decision to provide market surveillance authorities with a harmonised interpretation of what address a manufacturer (and when relevant an authorised representative) of medical devices shall put on the label and instructions for use.

The address shall be the address of the registered place of business of the legally responsible manufacturer and shall include the following details:

  • street/road,
  • number/house/floor,
  • postal code
  • city
  • state/region and country

 

 

 

The same details shall be provided for the address of the authorised representative.

The Compliance and Enforcement Group (COEN), was asked to appropriately enforce the implementation of this decision. 

Through this letter, agreed by COEN, the Competent Authorities within the medical devices sector are informing manufacturers, Authorised Representatives and national and European branch organisations of this decision. Competent Authorities within the medical device sector request that manufacturers implement the decision by September 2012. 

The decision will be applied by the market surveillance authorities as from 1st September 2012 giving industry a transfer period of one year.

The decision and more information of the CMC are available on the following Websites: http://www.cmc-md.eu/; www.cmc-md.eu/decisions.html

Should you require any clarifications please do not hesitate to contact Mr David Pulis at the MCCAA on or 2395 2000.

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