European Charter for the Responsible Development of Neurotechnologies

Over the last decades, advances in technology and in the understanding of the human nervous system have expanded the possibilities of using such knowledge under the form of devices and procedures, collectively referred to as neurotechnologies. Neurotechnologies are designed to interact with the brain and nervous system, providing support for the diagnosis, monitoring, and treatment of neurological and mental health conditions, thereby addressing unmet medical needs and promoting brain health globally. Beyond their clinical utility, neurotechnologies are being mobilised in a growing number of settings beyond health and research, including education, the workplace, and the direct­-to-consumer market for entertainment and personal use.

Neurotechnologies have great potential to foster brain health. Clinical tools range from Magnetic Resonance Imaging (MRI) and Electroencephalography (EEG) to Deep Brain Stimulation (DBS), each holding transformative power for both diagnosis and management of neurological and mental health conditions. Furthermore, the growing accessibility and portability of neurotechnologies, along with their potential applications in everyday life, have expanded their use beyond the medical field and into the general consumer market (for example in work, education, entertainment, and marketing). Consequently, over the past decade, the field of neurotechnology applications has grown exponentially, with the neurotechnology market projected to reach more than $24 billion by 2027. However, the uses of neurotechnologies both in the medical field and the general consumer market raise crucial ethical and societal issues—notably in terms of human enhancement, regulation and marketing of direct-to-consumer devices, protection of personal neural data and vulnerability of cognitive patterns for commercial or political manipulation.

The European Charter for the Responsible Development of Neurotechnologies is a policy-driven project complementing EU consumer protection and general product safety standards. Acknowledging the unique role of the brain in governing cognitive processes and personal identity, the Charter refreshes the European policy debate on technology governance by promoting a culture of stewardship and trust in neurotechnologies, supporting greater wellbeing and sustainable economic growth, and guiding public policy, activities of companies and investments.

About the Charter

With the ultimate goal to promote a culture of stewardship and trust in neurotechnologies, to foster greater wellbeing and sustainable economic growth, and to guide public policy, business practices and investments, the European Charter for the Responsible Development of Neurotechnologies builds upon and complements existing mechanisms of governance and legislation by contributing to human-centred risk evaluations, addressing gaps and shedding light on grey areas deserving public attention and robust governance. Considering the rapidly expanding nature of neurotechnologies, the Charter is designed as a dynamic document, subject to regular review and updates.

This Charter was jointly elaborated by diverse stakeholders in the field and its content emerged from collaborative dialogues between public and private sectors. Through a public consultation, the Task Force also gathered insights and feedback from various age groups and stakeholder categories across Europe. The Charter reflects a bottom-up, co-creative approach, bringing together key stakeholders in the European brain ecosystem, including organisations of people living with mental, neurological or sensory conditions, organisations of professional actors in health, research and ethics, policymakers, small and medium-sized enterprises.

Aims

Promoting

equality of access and encouraging responsible, human-centred and rights-oriented innovation and business conduct

Protecting

individuals, communities and vulnerable populations against any abuse or misuse affecting notions of human identity, freedom of thought, autonomy, privacy and human flourishing

Informing

the general public, industry, scientific and clinical practice, as well as policymaking

Supporting

the economic growth of the field by strengthening trust between all actors and promoting societal deliberation and citizen participation

Authors of the Charter

Sameer Zuberi

Royal Hospital for Children & University of Glasgow, UK

Dylan Muir

Synsense, Zürich, Switzerland; University of Western Australia, Perth, Australia

Pascal Maigne

French Agency of Biomedicine

Kostas Kostarelos

INBRAIN Neuroelectronics

Jean-Antoine Girault

Federation of European Neuroscience Societies

Orla Galvin

European Federation of Neurological Associations

Jim Dratwa

European Commission

Hervé Chneiweiss

CNRS; EMBL Ethics Board; EBRAINS Ethics and Society Committee

Ricardo Chavarriaga

CAIRNE; Zürich University of Applied Science

Alice Accorroni

Resident and Research Fellow Section, European Academy of Neurology

Dieyenaba Faye

European Brain Council

Frédéric Destrebecq

European Brain Council

Contributors to the Charter

Neurorights Foundation

French National Advisory Ethics Council for Health and Life Sciences

Juliette Sénéchal (University of Lille; French Institute of Research in Digital Science and Technology)

Julie Rachline (LallianSe; Braintale)

Virginia Mahieu (Centre for Future Generations)

Ulrike Busshoff (Project Management Agency, German Aerospace Centre)

Endorse the Charter

Organisations Supporting the Charter

International Context and European Regulatory Landscape

EUR-LEX Access to European Union Law

Rules for trustworthy artificial intelligence in the EU

OECD Legal Instruments

Recommendation of the Council on Responsible Innovation in Neurotechnology

UNESCO

Ethics of Neurotechnology

Spanish Presidency

León Declaration on European neurotechnology

EUR-Lex Access to European Union Law

General data protection regulation (GDPR)

EUR-Lex Access to European Union Law

Ensuring the safety and performance of medical devices

EUR-Lex Access to European Union Law

Unfair commercial practices

EUR-Lex Access to European Union Law

REGULATION (EU) 2017/745 on medical devices

News & Resources

EuroNews

‘Our thoughts could be recorded’: What is neural data and what protections exist in the EU?

Euractiv

EU must advance brain science technology while ensuring citizens’ safety, say experts

Council of the European Union

From vision to reality: Promises and risks of Brain-Computer Interfaces

EU Policy Lab

Riding the (brain)waves - how foresight can inform EU regulation of new technologies

Panel for the Future of Science and Technology

The protection of mental privacy in the area of neuroscience

FAQ

What are neurotechnologies?

Neurotechnologies are devices and procedures used to access, monitor, investigate, assess, manipulate and/or emulate the structure and function of the neural systems of natural persons.

Medical devices, defined in the Medical Devices Regulation, cannot be placed on the European market without conforming to strict safety requirements including the affixation of the CE marking of conformity—indicating that a device is in conformity with the applicable requirements set out in this Regulation and other applicable Union harmonisation legislation providing for its affixing.

Non-medical applications include products for neurostimulation and neurofeedback in work, education, entertainment and marketing. These devices often lack appropriate oversight regarding their scientific foundations, safety, efficacy and ethical supervision: for instance, EEG systems with an intended medical purpose require a pre-market approval, while EEG direct-to-consumer products are only subjected to the CE marking of conformity.

The field of neurotechnologies is advancing rapidly, fuelling global debate over their research, development, use and regulation. Various binding and non-binding mechanisms of governance are available to policymakers and other stakeholders—including laws, regulations and recommendations. Adopted in 2019, the Organisation for Economic Co-operation and Development (OECD) recommendation #457 on Responsible Innovation in Neurotechnology constitutes the first international standard in the field. The United Nations Educational, Scientific and Cultural Organization (UNESCO) report on the Ethical Issues of Neurotechnology (2021) was a landmark publication, and the upcoming UNESCO Recommendation on the Ethics of Neurotechnology (2025), as well as the work of the European Group on Ethics in Science and New Technologies, are set to further enrich the debate.

Launched under the Spanish Presidency of the Council of the EU in 2023 and resulting from an agreement by EU’s telecommunications and digital ministers, the León Declaration on European Neurotechnology represents a first move to protect digital rights in the development of neurotechnologies at the European level.

Although the EU still lacks specific regulations and directives dedicated to neurotechnologies, the Medical Devices Regulation (MDR), the General Data Protection Regulation (GDPR), the EU consumer protection law (the Unfair Commercial Practices Directive) and the more recent European Artificial Intelligence Act (EU AI Act) already provide baseline levels of consumer protection and general product safety standards relevant to the development of neurotechnologies in the EU.

A charter functions as a non-binding agreement that offers a more agile and flexible governance framework, which is especially beneficial for swiftly changing technologies:
– Charters can be implemented with minimal bureaucratic hurdles or delays and can be updated more quickly and more efficiently than regulations.
– As the commitments outlined in charters are not limited by geography, they often possess a global dimension.
– Charters foster collaboration among a diverse range of stakeholders who might otherwise be more inclined to oppose each other in conventional regulatory contexts.
– Charters provide a consensus framework spanning researchers, innovators, policy makers and civil society (while regulations typically have a narrower target audience).
– Charters are not only complementary to other binding and non-binding laws, but they also constitute a guideline for development of novel governance tools and enhance consistency between different legal jurisdictions.

With the ultimate goal to promote a culture of stewardship and trust in neurotechnologies, to foster greater wellbeing and sustainable economic growth, and to guide public policy, business practices and investments, the European Charter for the Responsible Development of Neurotechnologies builds upon and complements existing mechanisms of governance and legislation by contributing to human-centred risk evaluations, addressing gaps and shedding light on grey areas deserving public attention and robust governance.