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