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Council and Parliament reach deal on medical devices Regulations

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Agreed texts of two proposed Regulations on medical devices were endorsed by the Council of Ministers’ Permanent Representatives Committee (Coreper) and the European Parliament’s Environment Committee (ENVI) last week – paving the way for their formal adoption by the end of the year.

The proposed Regulations – one on medical devices and the other on in vitro diagnostic medical devices (IVDs) – will replace existing Directives. Their provisions will apply three years after publication for medical devices, and five years after for IVDs.

The revisions affected all kinds of medical devices including in vitro diagnostic devices, from home-use items like sticking plasters, pregnancy tests and contact lenses, to x-ray machines, pacemakers, breast implants, hip replacements and HIV blood tests.

Medical devices which are substances or mixtures, such as bone cements or dental filling materials, are covered by many of REACH’s provisions. Those which are articles are usually exempt, although suppliers of such medical articles must provide information on SVHCs if they receive a request from a consumer or recipient.

Since July 2014, electrical medical devices have also been covered by the revised Directive on the restriction of hazardous substances (RoHS) in electrical and electronic equipment.

The endorsed text for the medical devices Regulation includes a 0.1% concentration limit for category 1A and 1B CMRs and endocrine disrupting chemicals (EDCs) in devices that:

  • are invasive and come into direct contact with the body; or
  • (re)administer, transport or store medicines, body liquids or other substances, including gases, to/from the body.

EDCs are defined as those identified in accordance with the REACH candidate list procedure or according to the criteria set under the biocidal products Regulation. The European Commission’s proposed criteria for the latter were issued last week – and met widespread criticism from NGOs and industry.

Devices would only be permitted to contain such substances, at a level above this limit, if a justification is provided. This would have to be based on:

  • an analysis and estimation of potential patient or user exposure;
  • an analysis of alternative substances, materials or designs, including, where available, information about “independent” research, peer reviewed studies, scientific opinions from Commission committees and an analysis of the availability of such alternatives;
  • arguments to justify why any possible substitutes or design changes are “inappropriate to maintain the functionality, performance and the benefit-risk ratios of the product”. This would have to take into account any uses involving the treatment of children, pregnant or nursing women, or other vulnerable groups; and
  • where available, the latest scientific committee guidelines.

A mandate for the relevant scientific committee to prepare guidelines on phthalates would be provided by the Commission, “within a year of the Regulation’s entry into force. It would include a benefit-risk assessment of the presence of phthalates which are CMRs or EDCs. These would have to be updated at the latest every five years.

Subsequently, the Commission would issue similar mandates for the preparation of guidelines on other CMRs.

Labelling provisions

If “devices, parts thereof or materials used therein” contain a CMR or EDC above the concentration limit, it would have to be labelled on the device itself and on the packaging, with the list of such substances included.

Although it wants a phase-out of the use of all CMRs and EDCs in medical devices, NGO Health Care Without Harm said the guidelines should be based on the “latest” scientific research, taking into account their toxic effects when absorbed by the human body from devices.

It also said people would only be properly protected from the continued use of such substances in devices if this is validated by a competent EU agency. Currently, medical devices are validated by conformity assessment bodies, or “notified bodies”, some of which are profit-making companies. This remains unchanged under the proposed Regulations.

Also, all the “progressive steps” outlined in the text “are undermined by the Commission’s blatantly inadequate set of criteria for identifying EDCs”, said the NGO.

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