AUTHORISED REPRESENTATIVE

 

  • Medical Device Authorised Representative
  • Toy Authorised Representative

MEDICAL DEVICE AUTHORISED REPRESENTATIVE


Do I need to appoint an Authorised Representative?
   According to article 14, “Registration of persons responsible for placing devices on the market”, of the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, it is indicated that ‘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.
   If your company does not have a physical location within the EU, European law for medical devices dictates that you must appoint a European Authorised Representative located in Europe to act as your liaison with the national Competent Authorities. We are an official EU Authorized Representative for hundreds of medical device manufacturers around the world.


CE Marking Directives requiring appointment of Authorised Representative:

  •    • Medical Devices Directive (MDD) - 93/42/EEC as amended by 2007/47/EC
  •    • In Vitro Diagnostic Devices Directive (IVDD) – 98/79/EC
  •    • Active Implantable Medical Devices Directive (AIMDD) – 90/385/EEC


What does an Authorised Representative do?

  •    • Act as your primary point of contact for all European regulatory agencies
  •    • Assist with general questions about your product in the EU
  •    • Be available to interact between you and the European Competent Authorities
  •    • Assist with (near) incident reporting to Competent Authorities, in cooperation with you and your distributors
  •    • Allow you to place the Aemi World contact information on your device labeling (Instructions for Use, labels, packaging, etc.)
  •    • Protect the confidentiality of your documentation – as your EU Authorized Representative, we can only show your documentation to the Competent Authorities
  •    • Maintains a current copy of your Technical File available for inspection by the European Competent Authorities.
  •    • Represent you to the European Commission for consultation in case of withdrawal of a medical device by a Member State(s)
  •    • Maintain reports concerning the critical evaluation of all data collected during clinical evaluations for review by Competent Authorities
  •    • Notify, or be notified by, the Competent Authorities of serious device incidents

TOY AUTHORISED REPRESENTATIVE


   The Authorised Representative is, according to the new Toys Directive 2009/48/EC, any natural or legal person, who by a written mandate of the manufacturer, act on their behalf for specified tasks.
According to the new Toys Directive 2009/48/EC, article 5, a manufacturer of toys may appoint an authorised representative in Europe. This has to take place formally and by a written mandate between parties concerned. The ensuring that the toy is designed and manufactured in accordance with the essential requirements, and the compiling of the technical documentation may not form part of the authorised representative’s mandate.
   The authorised representative needs to keep the EC declaration of conformity and the technical documentation at the disposal of national authorities for a period of 10 years. On request from the competent national authorities, provide them with all the information and documentation necessary to demonstrate the conformity of the toy. The authorised representative should cooperate with the competent authorities, at the request of the latter, on any action to avoid the risks posed by toys covered by their mandate.
   The toy manufacturer needs to ensure that the toy is designed and manufactured according to the following essential requirements of the new Toys Directive :

         - EC declaration of conformity, including specific photo and product number;
         - Technical documentation and carry out the conformity assessment procedure;
         - Affix CE marking;
         - Keep the technical documentation and the EC declaration of conformity for 10 years;
         - Ensure that procedures are in place for series production to remain the conformity;
         - With regard to risks presented by toys, carry out sample testing, investigate, and, if necessary, keep a register of complaints;
         - Toys or packaging bear a type, batch, serial or model number, name manufacturer and contact address;
         - Toy is accompanied by instructions and safety information;
         - Take the corrective measures if a toy is not in conformity.
            Where a toy presents a risk, manufacturers shall inform the competent national authority;
         - To a request from a competent national authority, provide that authority with all the information and documentation necessary.

   Our technical and legal experts are able to determine the conformity of the toy according to the new European requirements for toys. This conformity assessment procedure is intended to evaluate if toys comply with the essential requirements of the new Toys Directive 2009/48/EC. On the basis of a conformity assessment procedure we can determine if the product is produced in accordance with the legal European requirements. Due to a Toys-Conformity-Report (TCR) our experts can immediately estimate the conformity of the toy and define technical- and information defects.
   On the basis of the TCR, we are able to define the conformity of the toy and/or the corresponding documentation.
   For further information regarding the testing and certification of toys, please contact us.

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