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.
This new regulation is planned to be adopted by 2015. Currently on-going active discussions are taking place at the European Parliament and the European Council.
COCIR welcomes the European Commission efforts on strengthening the European regulatory model for medical devices. Many proposals address the right points, putting patient and user safety first.
The revision is giving us an opportunity to enhance the transparency of the system, the traceability of medical devices and their critical components, to harmonise the role and engagement of the EU Member States and to have a better coordination of the future regulatory framework, especially for the post-market phase.
However, some points in the EC proposal are of particular concern and deserve special attention as they may cause redundant administrative burden and additional cost, without additional gain on public health aspects: i.e. Role and responsibilities for economic operators, Harmonised standards and Common technical specifications.
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 has developed its vision on a future European regulatory framework calling for:
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. 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
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.