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
MENU

Medical Device Regulation – One Year to Go

06.06.2019 Category: Position papers

Medical Device Regulation – One Year to Go


COCIR Recommendations

Brussels, 6 June 2019

The medical device sector in Europe has less than one year until 26 May 2020, the Date of Application of the Medical Device Regulation (MDR - 745/2017).

Six months ago, in November 2018, COCIR published a Opens external link in new windowhalf-time assessment .

Unfortunately, the updated assessment (see Related Documents) shows that very little progress has been made in the implementation of the Regulation.

We believe that our concrete recommendations will help to address the most urgent concerns faced by the EU regulatory system.

We count on the European Commission and member states to take a pragmatic approach to ensure that healthcare delivery will not face any negative consequences from the implementation of the new regulation.


Related documents

Files:
2019.06.06_MDR_assessment_June_2019_FINAL.pdf288 K