In the European Union (EU) the delivery of health services is a national responsibility but there are concerted actions between member states to protect public health. Approval of pharmaceutical products is the responsibility of the European Medicines Agency, while authorising the placing on the market of medical devices is decentralised to independent ‘conformity asssessment’ organisations called notified bodies. The first legal basis for an EU system of evaluating medical devices and approving their market access was the medical device directives, from the 1990s. Uncertainties about clinical evidence requirements, among other reasons, led to the EU Medical Device Regulation (2017/745) that has applied since May 2021. It provides general principles for clinical investigations but few methodological details ‒ which challenges responsible authorities to set appropriate balances between regulation and innovation, pre- and post-market studies, and clinical trials and real-world evidence. Scientific experts should advise on methods and standards for assessing and approving new high-risk devices, and safety, efficacy, and transparency of evidence should be paramount. The European Commission recently awarded a Horizon 2020 grant to a consortium led by the European Society of Cardiology and the European Federation of National Associations of Orthopaedics and Traumatology, that will review methodologies of clinical investigations, advise on study designs, and develop recommendations for aggregating clinical data from registries and other real-world sources. The CORE‒MD project (Coordination of Research and Evidence for Medical Devices) will run until March 2024; here we describe how it may contribute to the development of regulatory science in Europe.

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Makerspaces—informal shared spaces that offer access to technologies, resources and a community of peer learners for making—across the globe initiated a rapid response to the lack of medical hardware supplies during the global pandemic outbreak in early 2020 caused by the Corona virus (COVID-19). As our health systems faced unexperienced pressure, being close to collapsing in some countries, and global supply chains failing to react immediately, makers started to prototype, locally produce and globally share designs of Open Source healthcare products, such as face shields and other medical supplies. Local collaboration with hospitals and healthcare professionals were established. These bottom-up initiatives from maker networks across the globe are showing us how responsible innovation is happening outside the constraints of profit-driven large industries. In this qualitative study we present five cases from a global network of makers that contributed to the production of personal protective equipment (PPE) and healthcare-related products. We draw our cases from the experiences made in Careables, a mixed community of people and organizations committed to the co-design and making of open, personalized healthcare for everyone. With the presented cases we reflect on the potential implications for post-pandemic local production of healthcare products and analyze them from a social innovation perspective. These global experiences are valuable indications of transformative innovations that can reduce dependencies from international supply chains and mainstream mass production.

Journalists, non-profits and consumer organisations, as well as the authors' first-hand review of relevant privacy policies reveal that fertility and menstruation tracking apps (FMTs) collect and share an excessive array of data. Through doctrinal legal research, we evaluate this data processing in light of data and consumer protection law but find the commonly invoked concepts of 'vulnerability' , ' consent' and 'transparency' insufficient to alleviate power imbalances. Instead, drawing on a feminist understanding of work and the autonomist 'social factory' , we argue that users perform unpaid, even gendered, consumer labour in the digital realm and explore the potential of a demand for wages. Issue 4This paper is part of Feminist data protection, a special issue of Internet Policy Review

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