Europe

MEDICAL DEVICE REGULATION ADOPTED

COCIR welcomed the adoption of the Medical Device Regulation (MDR) after successful vote during the European Parliament Plenary Session on  5 April 2017.

READ HERE COCIR PRESS RELEASE

BACKGROUND

On 26 September 2012, the European Commission (DG SANCO) adopted a Proposal for a Regulation on medical devices and a Proposal for a Regulation on in vitro diagnostic medical devices which will, once adopted by the European Parliament and by the Council, replace the existing three medical devices directives.

 

COCIR VIEWS

COCIR has been contributing in those discussions since the very beginning of the EU process in 2008 by responding to EC public consultations, developing several position papers, giving high level presentations and meeting all key stakeholders at EU and national level to convey our members’ main messages.

In particular, COCIR developed its vision on a future European regulatory framework calling for:

  • A simple and integrated regulation (to avoid any overlapping directives)
  • A better coherence and uniformity of EU Member States approach (vigilance, registration)
  • An improvement of the performance of notified bodies (competence, impartiality and transparency)
  • The promotion of CE-marking principles inside and outside Europe and align with international norms
     

READ HERE COCIR HIGH LEVEL CONTRIBUTION

EXPERT PANEL ON EFFECTIVE WAYS OF INVESTING IN HEALTH

Launched at the initiative of the European Commission in July 2013, a multi-sectorial and independent Expert Panel provides advice to the European Commission on effective ways of investing in health.
In providing a non-binding advice, the expert panel has to take into account the work of other Union bodies concerned with the sustainability of health systems (e.g. Economic Policy Committee, Social Protection Committee).
The panel launches public consultations on wide range of subjects, to enable key players to have a voice on measures proposed.

COCIR responded to three public consultations launched by the Expert Panel, including:

  1. 1. Assessment of the study 'Evaluation of public-private partnerships in health care delivery across EU'. February 2014. Opinion Report available 
     In this Opinion, the Expert Panel on Effective Ways of Investing in Health provides a critical peer review of a report of a study on public-private partnerships, examined the strength of the evidence and of the conclusions, and provided the Expert Panel’s views on these partnerships.
  2. “Access to Health services in the European Union. November 2015.  
    Opinion Report available 
    Please find the COCIR response HERE 
  3.  “Disruptive Innovation in Health care. Considerations for the future”. December 2015. 
    Opinion Report available 
    Pease find the COCIR response HERE

HEALTH TECHNOLOGY ASSESSMENT

The potential of HTA for contribution to safer and more effective heath care is recognized throughout the Europe, and interest in this field has been growing steadily. 
With this respects, COCIR set up a specific Task Force to address issues related to HTA for medical devices, and is actively involved in the European Network for Health Technology Assessment, the Joint Actions 1, 2 and the 3rd which is currently being launched. 
Please visit the specific section devoted to COCIR HTA related activities.