COCIR Feedback: Draft standardisation request for the Medical Device Regulation and IVD Regulation

Brussels, 25 July 2019 - In response to the European Commission’s publication of the draft standardization request for the MDR and IVDR, COCIR has developed detailed feedback and recommendations for improvement of the document. We have always underlined the importance of having harmonised standards available and cited in the Official Journal under the new Regulations. 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. COCIR is more than ready to engage in further discussions with the European Commission and member states on this topic. We specifically call upon the next Commissioner for the Internal Market to find pragmatic solutions to the current deadlock