ELM-324-01

EU MDR Competent Authorities

Competent Authorities

Article 101 explains how the competent authorities are assigned responsibility for the implementation of the Regulation by the Member States.

In designating this responsibility, they are:

  • Given the authority;
  • Expected to have suitable resources;
  • Expected to have the requisite equipment; and
  • Required to have the appropriate level of knowledge and expertise,

in order to fulfill the roles and responsibility of implementation of the regulation.

The names and contact details of any assigned competent authorities shall be communicated to the Commission by the Member States, and the Commission will publish a full listing of all competent authorities.

Author

Ian Nicholls

Director at Explic8