cocir
sustainable competence in advancing healthcare
European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry
cocir
sustainable competence in advancing healthcare
European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry
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Regulations & Standards

COCIR has engaged regular dialogue with several European Commission Directorates General, including DG Health and Consumers (DG SANCO).

 

European Regulatory Affairs 

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 Opens external link in new windowhere  (23 January, 2018). In the group, we focus on the following activities:

  • Continuous monitoring of the Medical Devices Directives (MDD) and related guidance documents
  • Pro-active contribution and detailed impact assessment towards the implementation of the MDR, including:

    • The development of the European Databank on Medical Devices (EUDAMED)
    • The revision of guidelines and templates for clinical evaluation and post-market surveillance
    • The qualification and classification of Medical Device Software

  • Continuous monitoring of the Radio Equipment Directive and its impact on the medical device industry

Opens internal link in current windowLEARN MORE ABOUT EUROPEAN REGULATORY AFFAIRS 

 

International Regulatory Affairs

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:

  • convergence of regulatory frameworks worldwide

  • use of international standards as a complementary tool to regulatory frameworks

  • reduction of regulatory burden worldwide

  • cooperation among sister trade associations in non-EU countries

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.

Opens internal link in current windowLEARN MORE ABOUT INTERNATIONAL REGULATORY POLICIES

 

Radiation protection

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 (Opens external link in new windowHERCA),  the International Atomic Energy Agency (Opens external link in new windowIAEA) and the European Federation of Organisations in Medical Physics (Opens external link in new windowEFOMP).

Opens internal link in current windowLEARN MORE ABOUT REGULATORY POLICIES AFFECTING MEDICAL DEVICES USING IONIZING RADIATION

 

Electromagnetic Fields (EMF)

The Electromagnetic Fields (EMF) Task Force was created to ensure that the Opens external link in new windowEMF 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 (Opens external link in new windowESR) on this important matter.

Opens internal link in current windowLEARN MORE ABOUT REGULATORY POLICIES AFFECTING MR TECHNOLOGY

 

Standardisation Policy

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. 

Experts involved in this Focus Group constantly monitor and contribute directly in activities at International  level through Opens external link in new windowISO and Opens external link in new windowIEC and at  European level through Opens external link in new windowCEN-CENELEC.

Opens internal link in current windowLEARN MORE ABOUT STANDARDISATION POLICY