cocir
sustainable competence in advancing healthcare
European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry
cocir
sustainable competence in advancing healthcare
European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry
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Harmonisation of Standards for Medical Devices

02.04.2019 Category: Position papers

Harmonisation of Standards for Medical Devices


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