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.

MDCG 2023-4 addresses MDSW that cannot achieve its intended medical purpose without hardware or a hardware component, setting out three regulatory scenarios (desktop PCs and cloud platforms are out of scope): (1) the hardware qualifies as an accessory to the MDSW under MDR Annex VIII classification rules; (2) the hardware is placed on the market as a standalone medical device -- as part of a system (Art. 22), a combination (Art. 2(1)), or an integral component -- in which case the manufacturer may rely on the hardware's MDR conformity for general safety and performance requirements, though clinical evaluation must still cover the combined intended purpose; (3) the hardware is part of a general consumer or wearable product with no medical device/accessory status, in which case the MDSW manufacturer bears sole responsibility for the safety, performance and reproducibility of the combination across all supported configurations, with correspondingly broader post-market surveillance. Illustrative examples include dermal sensor patches and smartwatches (temperature, SpO2, heart rate) paired with a companion app.