European representative

The following is a guidance to PPE manufacturers based outside of the European Union - Representation within the EU.

Based on an EC guidance document and Council Directive covering conformity assessment, the position appears to be as follows:  

  • A manufacturer may be located either inside or outside of the EU
  • A manufacturer in either case, may appoint an EU representative
  • An EU representative must be located inside the EU
  • Where the manufacturer is located outside of the EU and has not appointed an EU representative, then he must appoint at least one importer to hold a copy of the type examination certificate and technical file for each item of PPE to be placed on the European market
  • These documents must be held available for submission to a “competent authority”, should this be requested
  • The responsibilities of the EU representative, or importer, are confined to performing the functions as required by the PPE Directive, and the manufacturer must delegate and limit these responsibilities in writing

Please note that this is INSPEC's view of the current position and does not constitute an official interpretation or ruling.

 

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