Guidance (MDCG 2024-11, published October 2024) on how to determine whether a product qualifies as an in vitro diagnostic medical device (IVD) or IVD accessory under the IVDR (Regulation (EU) 2017/746). It sets out the general principle that qualification depends on the intended purpose given by the manufacturer, as indicated on labelling or in promotional material, and applies the definitions in Article 2(2) and 2(4) of the IVDR. The guidance provides a non-exhaustive set of examples to help distinguish IVDs from borderline cases, including devices falling under the MDR, non-medical products such as ancestry or lifestyle tests, and tests used to monitor the manufacturing of other products such as pharmaceuticals, and recommends using it alongside the Manual on borderline and classification.

Revision 1 of MDCG 2022-5 (published 29 October 2024), guidance on the borderline between medical devices and medicinal products under the MDR (Regulation (EU) 2017/745). It covers the core concepts for making this distinction, including the definitions of pharmacological, immunological and metabolic means of action, the treatment of plant-based or herbal substances (to which the same principles as conventional medicinal substances apply), substance-based medical devices (where Rules 3 and 21 are relevant), and combination products of medical devices and medicinal products, illustrated with a flowchart of regulatory outcomes for different scenarios. It confirms that a product containing a medicinal substance can still qualify as a medical device where that substance plays an ancillary role and the principal intended effect is not achieved by pharmacological, immunological or metabolic means. Revision 1 adds new text on products intended solely for cleaning, disinfection or sterilization, clarifying that single-purpose products of this kind are medical devices, while multi-purpose disinfectants fall under the Biocidal Products Regulation (EU) No 528/2012.

EU regulation establishing a risk-based framework for artificial intelligence, dated 13 June 2024 and published in the Official Journal on 12 July 2024. It sets out prohibited practices and requirements for high-risk AI systems. Medical device AI becomes high-risk where it is a safety component of a device, or is itself a device, and is subject to third-party conformity assessment by a notified body (MDCG 2025-6). Requirements for high-risk systems cover data governance, technical documentation, transparency, human oversight, and accuracy, robustness and cybersecurity; a single set of technical documentation is drawn up for the MDR or IVDR and the AI Act. Article 99 sets maximum fines of EUR 35 million or 7% of worldwide annual turnover for prohibited practices, and EUR 15 million or 3% for breaches of operator obligations, whichever is higher. As amended by Regulation (EU) 2026/1744, the high-risk requirements apply from 2 December 2027 for Annex III systems and from 2 August 2028 for Annex I products, which include medical devices.