COCIR, the European Co-ordination Committee of the Radiological, Electromedical and Healthcare IT Industry, has issued a position paper suggesting ways for the Commission to get the system for mandating and approving harmonised standards back on track. The paper makes a number of recommendations:
- Speed up the approval of the Standardisation Request;
- Ensure flexibility in the Standardisation Request;
- Allow for a flexible publication schedule for the Official Journal of the EU;
- Streamline the assessment of Annex Zs;
- Active participation by European Regulators, including the European Commission, in standards development;
- Provide a process for swift harmonization of standards under MDR and IVDR.