The Medical Device Coordination Group (“MDCG”) has published a new position paper (MDCG 2022-14) acknowledging the significant and urgent lack of capacity of EU notified bodies. It acknowledges the risk that this could lead to many existing and new medical devices and in vitro diagnostic medical devices (“IVDs”) not
In April 2021, the European Commission released its proposed Regulation Laying Down Harmonized Rules on Artificial Intelligence (the “Regulation”), which would establish rules on the development, placing on the market, and use of artificial intelligence systems (“AI systems”) across the EU. The proposal, comprising 85 articles and nine annexes, is part of a wider package of Commission initiatives aimed at positioning the EU as a world leader in trustworthy and ethical AI and technological innovation.
The Commission’s objectives with the Regulation are twofold: to promote the development of AI technologies and harness their potential benefits, while also protecting individuals against potential threats to their health, safety, and fundamental rights posed by AI systems. To that end, the Commission proposal focuses primarily on AI systems identified as “high-risk,” but also prohibits three AI practices and imposes transparency obligations on providers of certain non-high-risk AI systems as well. Notably, it would impose significant administrative costs on high-risk AI systems of around 10 percent of the underlying value, based on compliance, oversight, and verification costs. This blog highlights several key aspects of the proposal.
Continue Reading European Commission Proposes New Artificial Intelligence Regulation
On 11 November 2020, the European Data Protection Board (“EDPB”) issued two draft recommendations relating to the rules on how organizations may lawfully transfer personal data from the EU to countries outside the EU (“third countries”). These draft recommendations, which are non-final and open for public consultation until 30 November 2020, follow the EU Court of Justice (“CJEU”) decision in Case C-311/18 (“Schrems II”). (For a more in-depth summary of the CJEU decision, please see our blog post here and our audiocast here. The EDPB also published on 24 July 2020 FAQs on the Schrems II decision here).
The two recommendations adopted by the EDPB are:
In this edition of our regular roundup on legislative initiatives related to artificial intelligence (AI), cybersecurity, the Internet of Things (IoT), and connected and autonomous vehicles (CAVs), we focus on key developments in the European Union (EU).
Continue Reading AI, IoT, and CAV Legislative Update: EU Spotlight (Third Quarter 2020)
In this final instalment of our series of blogs on the European Commission’s plans for AI and data, announced on 19 February 2020, we discuss some potential effects on companies in the digital health sector. As discussed in our previous blog posts (here, here and here), the papers published by the European Commission cover broad concepts and apply generally — but, in places, they specifically mention healthcare and medical devices.
The Commission recognizes the important role that AI and big data analysis can play in improving healthcare, but also notes the specific risks that could arise given the effects that such new technologies may have on individuals’ health, safety, and fundamental rights. The Commission also notes that existing EU legislation already affords a high level of protection for individuals, including through medical devices laws and data protection laws. The Commission’s proposals therefore focus on addressing the gap between these existing rules and the residual risks that remain in respect of new technologies. Note that the Commission’s proposals in the White Paper on AI are open for public consultation until 19 May 2020.
Continue Reading European Commission’s Plans for AI and Data: Focus on Digital Health (Part 4 of 4)
On 19 February 2020, the new European Commission published two Communications relating to its five-year digital strategy: one on shaping Europe’s digital future, and one on its European strategy for data (the Commission also published a white paper proposing its strategy on AI; see our previous blogs here and here). In both Communications, the Commission sets out a vision of the EU powered by digital solutions that are strongly rooted in European values and EU fundamental rights. Both Communications also emphasize the intent to strengthen “European technological sovereignty”, which in the Commission’s view will enable the EU to define its own rules and values in the digital age. The Communications set out the Commission’s plans to achieve this vision.
Continue Reading European Commission’s plans on data and Europe’s digital future (Part 3 of 4)
The European Commission, as part of the launch of its digital strategy for the next five years, published on 19 February 2020 a White Paper On Artificial Intelligence – A European approach to excellence and trust (the “White Paper”). (See our previous blog here for a summary of all four of the main papers published by the Commission.) The White Paper recognizes the opportunities AI presents to Europe’s digital economy, and presents the Commission’s vision for a coordinated approach to promoting the uptake of AI in the EU and addressing the risks associated with certain uses of AI. The White Paper is open for public consultation until 19 May 2020.
Continue Reading European Commission’s White Paper on Artificial Intelligence (Part 2 of 4)
On 19 February 2020, the European Commission presented its long-awaited strategies for data and AI. These follow Commission President Ursula von der Leyen’s commitment upon taking office to put forward legislative proposals for a “coordinated European approach to the human and ethical implications of AI” within the new Commission’s first 100 days. Although the papers published this week do not set out a comprehensive EU legal framework for AI, they do give a clear indication of the Commission’s key priorities and anticipated next steps.
The Commission strategies are set out in four separate papers—two on AI, and one each on Europe’s digital future and the data economy. Read together, it is clear that the Commission seeks to position the EU as a digital leader, both in terms of trustworthy AI and the wider data economy.
Continue Reading European Commission Presents Strategies for Data and AI (Part 1 of 4)
On December 12, 2019, the European Parliament endorsed a non-binding resolution on enabling the digital transformation of health and care. The resolution calls on the European Commission to take a number of actions to foster the development of digital health systems in Europe to improve patient care and support research efforts — particularly those using innovative technologies such as AI.
Continue Reading European Parliament Endorses Digital Health Resolution
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 changes, the EU Medical Device Coordination Group (“MDCG”) has recently published guidance on the Qualification and Classification of Software in the MDR and IVDR (the “Guidance”).
The aim of the Guidance is to assist manufacturers with interpreting the new Regulations to assess whether their software meets the definition of a medical device or an in vitro diagnostic device (i.e., “qualification”); and if so, what regulatory class the software would fall under (i.e., “classification”).
The MDCG is a coordination group established under Article 103 of the MDR, comprising up to two medical device experts from each EU Member State. Its key functions include contributing to the development of guidance to ensure effective and harmonized implementation of the EU’s new medical device rules. The Guidance is not legally binding nor does it necessarily reflect the official position of the European Commission. However, given the MDCG’s important role in the regulatory landscape, the Guidance is likely to be highly persuasive.