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EU Medical Device Coordination Group Publishes Guidance on the Qualification and Classification of Software under Upcoming Medical Device Regulations

The EU’s regulatory rules for medical devices are due to change on 26 May 2020, when the new Medical Device Regulation (“MDR”)[1] comes into effect.  The regime for in vitro diagnostic devices will change two years later from 26 May 2022 when the In Vitro Diagnostic Devices Regulation (“IVDR”)[2] will apply. In advance of these … Continue Reading

European Parliamentary Research Service issues a briefing paper on implementing EU’s ethical guidelines on AI

On 19 September 2019, the European Parliamentary Research Service (“EPRS”)—the European Parliament’s in-house research service—released a briefing paper that summarizes the current status of the EU’s approach to developing a regulatory framework for ethical AI.  Although not a policymaking body, the EPRS can provide useful insights into the direction of EU policy on an issue. … Continue Reading

Commission relaunch of eHealth Stakeholder Group

On 13 August 2019, the European Commission opened a call for expression of interest to relaunch the eHealth Stakeholder Group with a view to supporting the “digital transformation of healthcare in the EU”. The eHealth Stakeholder Group was first launched in 2012 and in its first iteration (between 2012 and 2015), contributed to the development … Continue Reading

French medicines regulator produces first in Europe medical devices cybersecurity guidelines

France’s medicines regulator, the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), has released draft guidelines, currently subject to a public consultation, setting out recommendations for manufacturers designed to help prevent cybersecurity attacks to medical devices. Notably, the draft guidelines are the first instance of recommendations released by a national regulator … Continue Reading

EU High-Level Working Group Publishes Ethics Guidelines for Trustworthy AI

On 8 April 2019, the EU High-Level Expert Group on Artificial Intelligence (the “AI HLEG”) published its “Ethics Guidelines for Trustworthy AI” (the “guidance”).  This follows a stakeholder consultation on its draft guidelines published December 2018 (the “draft guidance”) (see our previous blog post for more information on the draft guidance).  The guidance retains many … Continue Reading

Council of Europe issues recommendation on health-related data

On March 28, 2019, the Council of Europe* issued a new Recommendation on the protection of health-related data.  The Recommendation calls on all Council of Europe member states to take steps to ensure that the principles for processing health-related data (in both the public and private sector) set out in the Appendix of the Recommendation … Continue Reading

EMA-HMA joint taskforce publish report outlining recommendations for using ‘big data’ for medicines regulation

On 15 February 2019, the European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) published their Joint Big Data Taskforce’s summary report (available here) setting out recommendations for understanding the acceptability of evidence derived from ‘big data’ in support of the evaluation and supervision of medicines by regulators. The Taskforce has sought to clarify … Continue Reading

Reconciling Personalized Nutrition with the GDPR

As with anything personalized, be it advertising, medicines or training schedules, also personalized nutrition — using information on individual characteristics to develop targeted nutritional advice, products, or services — risks being affected by the feared GDPR.  Kristof Van Quathem discusses the topic in Vitafoods’ Insights magazine of January 2019, available here.… Continue Reading

Are Wearables Medical Devices Requiring a CE-Mark in the EU?

Wearable watches that help consumers obtain a better understanding of their eating patterns; wearable clothes that send signals to treating physicians; smart watches: they are but a few examples of the increasingly available and increasingly sophisticated “wearables” on the EU market. These technologies are an integrated part of many people’s lives, and in some cases … Continue Reading
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