In an Opinion published today, the COMECE Reflection Group on Bioethics, while welcoming the ongoing revision of European legislation on Medical Devices, warns against some ethical shortcomings and proposes improvements to Proposals which will be voted in the Environment, Public Health and Food Safety Committee of the European Parliament on 18 September.
There are currently around half a million medical devices (MDs) on the market in Europe, ranging from corrective glasses and contact lenses, to X-ray machines, pacemakers and in vitro diagnostic medical devices (IVDMDs). But are they really safe? Are we fully aware of the ethical implications that their use may have on individuals?
In order to tackle those challenges, market monitoring and vigilance, the European Union is currently conducting a revision of the legislative framework that governs MDs and IVDMDs in order to improve their assessment and the level of market vigilance.
The COMECE Reflection Group on Bioethics therefore welcomes the aims of this revision. However, after a rigorous analysis of the legislative Proposals presented by the European Commission on 26 September, it identified some shortcomings:
1. IVDMDs should be recognised as inseparable from genetic counselling by a medical doctor which allows for informed consent;
2. Risks of tests related to polygenic diseases can justify the refusal of their certification and the restriction of their advertising to medical circles;
3. Member States should be fully recognised as entitled to restrict in some cases the marketing of devices;
4. The psychological and social dimensions of safety should be taken into consideration;
5. Predictive tests for genetic diseases should neither be carried out for the purposes of selection of human beings nor be conducted on minors or temporally incapable adults;
6. The applicability of national law on ethical issues and the relevance of the Convention of Oviedo should be explicitly recognised;
7. The Principle of Subsidiarity in regard to the protection of the human embryo must be fully respected;
8. The criterion for classification of an IVDMD as a Class D should be consistently applied;
9. Additional requirements are needed for certification of certain devices such as devices that would make use of human embryonic stem cells.
Download the full Opinion in PDF (available in French and English) or read the Executive Summary (available in French and English).
COMECE is the Commission of the Bishops’ Conferences of the European Union, and comprises 26 Bishops representing all Member States of the EU. For more than thirty years now, COMECE has been accompanying the process of European integration, and offering its reflections. COMECE is now a partner of the EU institutions in the dialogue foreseen by Article 17 (3) of the Treaty on the Functioning of the EU.