EU Regulatory Roundup, May 2023: MDR Extension Updates Resume
Executive Summary
May saw a resurgence of EU MDR news, following a few quieter weeks. Guidance on demonstrating compliance with extended transition periods and compiling clinical investigation reports were among the top-read articles in Medtech Insight in the past month.
With the dust finally beginning to settle after the European Commission’s rush earlier in the year to rapidly adopt amendments to the Medical Device Regulation that extend compliance deadlines for some legacy devices, May saw a number of updates on the finer details of these new rules.
The EU updated its guidance document, MDCG 2020-3, which relates to “significant changes” for devices CE marked under the Medical Devices Directive or Active Implantable Medical Devices Directive regarding the transitional provision set out in Article 120 of the MDR.
The document confirms that legacy products granted certificates under the directives cannot have undergone significant changes if they are to benefit from the extended transition deadlines. The latest version of this guidance has added clarifications and examples of changes, and has been aligned with the EU MDR amending regulation.
Meanwhile, TEAM-NB rolled out a letter template in early May that notified bodies can use to demonstrate that their clients may continue to market eligible legacy devices until the new transition deadlines. This same letter template was subsequently published on the commission website on 23 May.
The template also sets out devices for which the notified body is responsible for appropriate surveillance and those for which it is not, under the applicable directive.
Elsewhere in EU MDR news, TEAM-NB said it is working on a new position paper on how notified bodies will leverage their past assessments of manufacturers’ technical documentation.
Clinical Evidence Challenges
The tougher clinical evidence requirements set out in the MDR are already causing challenges for some device manufacturers, according to a first-of-its-kind research paper. The research study proved popular among Medtech Insight subscribers, and was the fifth most read article in May.
Indeed, the majority (54%) of respondents who took part in the research who market high-risk devices said they have removed ̶ or are planning to remove ̶ medical devices from the EU market due to challenges in demonstrating compliance with the stricter MDR clinical evaluation requirements.
The impact on medium-risk devices was far lower, with no respondents stating their intention to leave the EU market entirely. However, 20% did say they would launch elsewhere first.
New commission guidance on the content and structure of the summary of the clinical investigation report in the context of the MDR was also released in May; the MTI article is a useful resource for companies who are struggling with clinical evidence elements of the MDR.
AI Regulation And Policy
The EU Artificial Intelligence Act reached a milestone in May, after amendments to the draft landmark legislation were voted in by the European Parliament Internal Market and Consumer Protection (IMCO) and the Civil Liberties, Justice and Home Affairs (LIBE) Committees.
A plenary vote is due to take place in June, and policymakers said they are working hard to ensure the highly debated legislation is backed by a strong majority vote before it enters trilogue discussions later in the year.
The AI Act is set to have an enormous impact on the medtech sector, as it will introduce new conformity assessment rules for the majority of AI-based medical devices and digital health technologies.
AI was also the subject of a research paper published by experts as part of the CORE-MD project, a Horizon 2020 initiative that aims to improve the way in which high-risk medical devices are evaluated.
Researchers propose that the level of clinical evidence generated for AI medical devices is based on the inherent risks involved if the system should reach an incorrect conclusion or analysis. The experts argue in this paper that the term “AI” may be unhelpful in itself as it encompasses such a wide array of devices, and call for regulation to focus on the outcome of the algorithm in context.
Manufacturers of AI chatbots may also wish to heed advice from Erik Vollebregt, an expert medtech regulatory lawyer. In an interview with Medtech Insight, Vollebregt explained how app developers can avoid marketing their product as a medical device unintentionally and better understand when they must seek approval under the MDR.
Avoiding medical claims is key, as is ensuring products have built-in features that prevent machine learning models from diagnosing or offering treatment to patients with medical concerns, unless the device is specifically designed and approved for this use.
Top 10 Articles In May 2023
The following table lists the most popular European regulatory and policy articles among our subscribers in May 2023. They explore the themes mentioned above in significantly more detail.
To read the April 2023 regulatory round-up, see: EU Regulatory Round-Up, April 2023: Global Regulatory Issues Dominate EU Thinking