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COCIR publishes harmonised standards position paper

  • Posted by: inetika
  • Category: GLOBAL NEWS

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:

  1. Speed up the approval of the Standardisation Request;
  2. Ensure flexibility in the Standardisation Request;
  3. Allow for a flexible publication schedule for the Official Journal of the EU;
  4. Streamline the assessment of Annex Zs;
  5. Active participation by European Regulators, including the European Commission, in standards development;
  6. Provide a process for swift harmonization of standards under MDR and IVDR.
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