The European Regulatory Affairs Focus Group follows and contributes to the development of EU legislation impacting the medical devices sector and represents a unique industry voice towards EU institutions. Since 2008, COCIR has been actively engaged in developing the Medical Device Regulation (MDR). COCIR experts are deeply involved in the implementation of the Regulation, including participation in the relevant Working Groups coordinated by the European Commission under the umbrella of the Medical Device Coordination Group (MDCG).
The International Regulatory Affairs Focus Group was created in 2011 to influence and contribute to the development of regulations beyond the EU, and to inform its members on market access threats and opportunities.
COCIR is supporting the interest of its members by promoting:
Besides the International Organisations activities (IMDRF, AHWP, WHO, WTO, etc.), the International Regulatory Affairs Focus Group is monitoring the legislation developments in the BRICK countries: Brazil, Russia, India, China, Korea.
The Radiation Task Force was created in 2010 to monitor regulations in Europe and other regions affecting in particular Medical Devices using ionizing radiation (imaging, radiotherapy). The members of this focus group constantly assess the impact of regulatory changes related to radiation dose and are seeking for harmonization of those requirements across Europe.
The Radiation TF has engaged a regular dialogue with the European Commission Directorate General for Energy (ENER) and is active on the main following policies:
COCIR is also cooperating with other organisations such as the Head of the European Radiological protection Competent Authorities (HERCA), the International Atomic Energy Agency (IAEA) and the European Federation of Organisations in Medical Physics (EFOMP).
The Standardisation Policy Focus Group was created to serve the interest of COCIR members and articulate the benefits of standards in the regulatory environment. International Standards are considered "state-of-the-art" and as such are complementary to regulations on medical devices. International standards adopted in Europe are published on a regular basis as harmonised standards in in the Official Journal of the European Union. Those standards are voluntary and can be used as presumption of conformity to the requirements of the Medical Device Directives and Medical Device Regulation.