The Medical Device Regulation (MDR) was adopted in May 2017. The Regulation aims to harmonise the European market for medical devices, building on the Medical Devices Directives in a constant evolution.
26 May 2021 marked the Date of Application of the European Medical Device Regulation (MDR). Replacing the Medical Devices and Active Implantable Medical Devices Directives, the Regulation is a welcome update for patient safety, transparency, and access to medical devices for Europeans.
Lessons learned from implementing the Medical Device Regulation. Read more
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.
The implementation process is now in a critical phase where secondary legislation is being drafted. COCIR, as one of the main industry stakeholders, is actively involved at this crucial stage through detailed analysis of the impact on businesses and working with member states and the European Commission towards successful implementation. COCIR also regularly publishes assessments of the implementation status and policy recommendations.
The Medical Device Regulation introduces several new obligations and responsibilities for manufacturers, as well as the new role of e the new role of economic operator, determining the respective tasks of actors in the supply chain, including manufacturers, importers and distributors. Medical device manufacturers have to make changes to the entire process of classification, conformity assessment and post market surveillance.
The European Commission has put together a catalogue of resources to prepare for the new Regulation on their website, including factsheets and infographics to explain the obligations for manufacturers.
COCIR regularly publishes an assessment of the implementation status of the Regulation. You can access the latest publications here (June 2019), here (November 2018), and here (January 2018).
1. Timely availability of unambiguous guidance, secondary legislation, Harmonised Standards and EUDAMED
2. Timely designation of Notified Bodies
3. Continued possibility for legacy devices to be placed on the market after May 2020 (“grace period”)
4. Consideration of the specificities of medical software
5. Timely industry consultation on all relevant guidance and documents (including those from CAMD)
6. Reduction of administrative burden as far as possible
7. Limited impact on time to market, avoiding unexpected issues as far as possible
COCIR created dedicated working groups to bring together experts from the membership and contribute to the work of the Medical Coordination Group, including on Medical Software, Post-Market Surveillance, Clinical Evaluation, Unique Device Identification & EUDAMED. In addition, we offer the following activities:
• Up-to-date regulatory intelligence and latest news delivered in regular newsletters
• In-depth exchanges with our network of members to share experiences and guide compliance efforts
• Internal guidance documents on various elements of the Regulation to support our members in becoming and staying compliant – visit the COCIR Members Area!
• Dedicated webinars for our members where various aspects of the implementation are discussed with regulatory experts and policy makers•
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.