On the 7th March 2017, the European Council adopted new EU rules to improve the safety of medical devices: benefitting patients whilst preserving access to innovative healthcare solutions.
HCWH Europe expressed major concerns about the Medical Devices Regulation, believing that it should address the presence of Carcinogenic, Mutagenic, and Reprotoxic substances (CMRs) and Endocrine Disrupting Chemicals (EDCs) contained in medical devices.
Annex I.2.7.4, of the Medical Devices Regulation includes a 0.1% concentration limit for category 1A and 1B CMRs and EDCs in devices that are invasive and come into direct contact with the body. This includes devices that: (re)administer, transport, or store medicines, body liquids, and other substances (including gases), to or from the body. Devices would only be permitted to contain such substances at a level above this limit if a justification is provided.
Importantly, within a year of the Regulation’s entry into force, the European Commission will provide a mandate for the relevant scientific committee to prepare guidelines on phthalates. This would include a risk-benefit assessment of their presence, (as they are known CMRs or EDCs) – such assessments would have to be updated within five years. The Commission would also issue similar mandates for the preparation of guidelines on other CMRs.
Annex II of the Regulations also includes labelling provisions: both a label on the device and the packaging would have to state if the device(s), and their parts or materials contain CMRs or EDCs above the concentration limit; a list of such substances must be included.
The European Parliament is expected to adopt the two regulations in April, after which they will be published in the Official Journal. These new rules will apply to medical devices and vitro diagnostic medical devices three and five years after the regulations are published respectively.
The new EU regulation:
- This new Medical Devices Regulation provides a stronger mandate to independent notified bodies in their assessment of medical devices before they can be placed on the market, and strengthens the oversight of these bodies by national authorities.
- These new rules also ensure that notified bodies meet the same high safety standards throughout the EU.
- These measures will both improve the safety of medical devices and improve the availability of clinical data on devices, as well as clearly set out manufacturers' responsibilities for the follow-up of the quality, performance, and safety of devices on the market.
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