COCIR has engaged regular dialogue with several European Commission Directorates General, including DG Health and Consumers (DG SANCO).
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. As we strive to make the implementation of the Regulation a success, you can access our most recent and detailed views here (23 January 2018). In the group, we focus on the following activities:
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 Electromagnetic Fields (EMF) Task Force was created to ensure that the EMF Directive does not limit the use, development or service of Magnetic Resonance Imaging (MRI), while maintaining a safe working environment.
COCIR has engaged regular dialogue with the European Commission Directorate General for Employment (EMPL) and is supporting its membership to promote full exemption of MRI from the scope of the Physical Agents Directive 2004/40/EC or equivalent provisions. COCIR is also cooperating with the European Society of Radiology (ESR) on this important matter.
The Standardisation Policy Focus Group was created to serve the interest of COCIR members and articulate benefits of standards in 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 JOCE. Those standards are voluntary and can be used as presumption of conformity to Essentials Requirements of Medical Device Directives.