Harmonisation of Standards for Medical Devices

Brussels, 2 April 2019

The European Commission needs to take action now to eliminate the remaining backlog of harmonised standards and re-install a sustainable and efficient process for the harmonisation of standards as outlined in their recent Communication.

Herafter are the 6 COCIR recommendations:

  1.       Speed up the approval of the Standardisation Request;
  2.       Ensure a flexible Standardisation Request;
  3.       Realize a flexible publication schedule for the Official Journal of the EU;
  4.       Streamline the assessment of Annexes Z;
  5.       European Regulators including the European Commission should actively participate in standards development;
  6.       Provide for a process for swift harmonization of standards under MDR and IVDR