Answer given by Ms Kyriakides on behalf of the European Commission
27.5.2024
Implantable medical devices fall into the scope of Regulation (EU) 2017/745 on medical devices[1] (MDR) and must comply with its general safety and performance requirements.
Devices intended to be implanted in the brain of human patients, being in contact with the central nervous system, are classified in the highest risk class (III) taking into account the intended purpose of the devices and their inherent risks. Therefore, the applicable requirements are especially stringent.
Ethical aspects of the use of medical devices are not specifically regulated in the MDR. However, it requires that any clinical investigation with a medical device, which is mandatory to gather pre-market clinical data for implantable and class III devices, is designed and conducted in such a way that the rights, safety, dignity and well-being of people participating in the clinical investigation are protected. Clinical investigations are subject to scientific and ethical review, performed by ethics committees in accordance with national law.
The ongoing CORE-MD project[2], set up to improve methods for clinical investigation and evaluation of high-risk medical devices, in the framework of the EU Horizon 2020 project, will deliver an ethics charter for the use of high-risk devices.
The European Group on Ethics in Science and New Technologies (EGE)[3] has set up a Working Group on ethics and governance of neurotechnology to issue policy recommendations by beginning of 2025.
The Commission is cooperating with the Council of Europe, and the Organisation for Economic Cooperation and Development (OECD) in the context of the recommendation on Responsible Innovation in Neurotechnology[4], towards the development of a robust international framework in that regard.
- [1] Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. ELI current consolidated version: https://eur-lex.europa.eu/eli/reg/2017/745/2023-03-20?locale=en
- [2] Coordinating Research and Evidence for Medical Devices (CORE-MD): https://www.core-md.eu/. It has received funding from the European Union’s Horizon 2020 research and innovation programme.
- [3] https://research-and-innovation.ec.europa.eu/strategy/support-policy-making/scientific-support-eu-policies/european-group-ethics_en
- [4] https://www.oecd.org/science/recommendation-on-responsible-innovation-in-neurotechnology.htm