COCIR, the Trade Association for the Medical Imaging industry delivers a scathing public feedback on the draft standardisation request for the MDR and IVDR.
COCIR lamented the lack of transparency and highlighted the less than adequate responses to the concerns they initially raised.
In their open letter, COCIR recommends to the European Standardisation Organisations to reject this request if it is adopted in the currently proposed form.
Unfortunately, the proposed draft standardisation request still includes several elements that prevent flexible harmonisation and timely reference of standards in the Official Journal. COCIR recommends to the European Standardisation Organisations to reject this request if it is adopted in the currently proposed form.
For more information about COCIR, click here.
