What is National Registration?

   In 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”. In paragraph 2 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. For devices referred to in the first subparagraph of paragraph 1, the authorised representative shall inform the competent authority of the Member State in which he has his registered place of business of the details referred to in paragraph 1.
   In paragraph 1 it says, ‘Any manufacturer who, under his own name, places devices on the market in accordance with the procedures referred to in Article 11 (5) and (6) and any other natural or legal person engaged in the activities referred to in Article 12 shall inform the competent authorities of the Member State in which he has his registered address of business and the description of the devices concerned.

We can help your national registration

  •    • Registers your devices with the national Competent Authorities before they are marketed.
  •    • Maintains a current copy of your Technical File available for inspection by the European Competent Authorities.
  •    • Acts as your primary contact point for all national Competent Authorities.
  •    • Interact between you and the national Competent Authorities.