The competent authorities are responsible for transposing the requirements of European regulations into national legislation.
The competent authority belongs to the government of the Member State of the European Union (EU) and their responsibility is to transposes the requirements of European regulations into national legislation. The competent national authorities supervise compliance with national statutes and regulations.
In the case of medical devices, Article 101 of Regulation (EU) 2017/745 on Medical Devices (MDR) indicates that each Member States shall designate a competent authority that will be responsible for implementing this Regulation. In addition, the Member State shall communicate the details of the competent authority to the European Commission, which then publishes a list with the relevant data.
There is an umbrella group of national Competent Authorities for Medical Devices (CAMD). This group was created to improve communication and collaborative work between these competent authorities, as well as to enhance the surveillance of medical devices on the market. All national competent authorities work together in the CAMD network to promote patient safety. The CAMD also supported the European Commission in identifying areas or sections of the Directive 93/42/ECC that required review for the development of Regulation (EU) 2017/745.
In this article, we leave you a list of all the competent authorities of the countries of the EU, the European Economic Area (EEA), and those that have another kind of agreement with the EU like Switzerland or Turkey1,2,3.