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