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NGOs Position Paper on the EC proposal for a Medical Device Regulation COM(212) 542

HEAL, alongside several other NGOs led by Health Care Without Harm Europe (HCWH), have issued a joint position paper on the European Commission’s proposal for a revised law on Medical Devices.

The proposal upgrades the existing Medical Devices Directive to a Regulation (applicable directly in all Member States without ‘national transposition’). The proposal is currently going through ‘co-decision’ in the European Parliament and Council.

HEAL and fellow NGOs call for a Regulation that moves beyond the Directive’s labeling of hazardous chemicals used in medical devices to phase them out by specified deadlines, unless no safer alternatives are available. These hazardous chemicals include carcinogens, mutagens and reproductive toxicants, and Endocrine Disrupting chemicals.

HEAL and other NGOs, as part of the EDC free coalition, call for the new regulation to establish the mechanisms to promote substitution of hazardous chemicals as quickly as possible in the European health care system. HEAL and the EDC free coalition partners are advocating the phase out of EDCs in a number of sectors, including medical devices, in line with the politically agreed bans on EDC pesticides and biocides, and the requirement for authorization of EDCs in the ‘industrial’ chemical sector.

The EU is currently in the process of revising its EDC Strategy, and the call for a phase out of EDCs in Medical Devices is in line with the recognition in other sectors that EDCs are harmful to our health and the environment.

Last updated on 11 June 2013

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The Health and Environment Alliance (HEAL) is a leading European not-for-profit organisation addressing how the environment affects health in the European Union (EU). We demonstrate how policy changes can help protect health and enhance people’s quality of life. Read more »


HEAL has over 70 member organisations, representing health professionals, not-for-profit health insurers, doctors, nurses, cancer and asthma groups, citizens, women’s groups, youth groups, environmental NGOs, scientists and public health institutes. Members include international and Europe-wide organisations, as well as national and local groups. Read more »

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