The free movement of medical devices is not an empty promise
In its judgment of November 24, 2016, the Court of Justice stated that European regulations prohibit Member States from requiring that a medical device which is authorised in the Union is subject to a new conformity assessment procedure.
The fact that a parallel importer changes the packaging and puts its name on it does not change this principle.
In addition, the Court recalls that Member States have sufficient legal instruments in order to ensure the quality of medical devices; if they identify a health risk or patient safety, they can take interim measures for ensuring this safety and must inform the Commission immediately of any medical device vigilance problem. These mechanisms are the only measures that Member States can implement in case of identified or suspected security problems.
The balance between the free movement of products and safety and health is thus sufficiently ensured.
This judgment poses the question of the conformity of the Belgian system of categorisation of medical devices which aims, for greater security, to impose on distributors the classification and categorisation of the products that they distribute.
Associated areas of specialisation: Health and social security