Revision 5 (September 2026) of the MDCG guidance on interpreting the classification rules in Annex VIII of the IVDR (Regulation (EU) 2017/746). It sets out the principles for classifying IVDs into classes A to D based on intended purpose and inherent risk, and provides the rationale and non-exhaustive examples for each of Rules 1 to 7. Software that drives or influences the use of a device falls within the same class as the device, while software independent of any other device is classified in its own right, with reference to MDCG 2019-11. Annexes provide examples of classifying IVDs used in combination and a flowchart to help determine whether an IVD is a companion diagnostic. Revision 5 clarifies the rationale of Rule 7 (controls without an assigned value) and revises its examples. The guidance is not legally binding.

Version 5 (April 2026) of the manual recording agreements reached by the competent authorities of the Member State members of the Borderline and Classification Working Group (BCWG), a subgroup of the MDCG, through the Helsinki Procedure under the MDR and IVDR. It presents the background and outcome of cases on qualification (borderlines between medical devices or IVDs and medicinal products, biocides, cosmetics, personal protective equipment and other products) and on the application of classification rules. Software-related cases include a smartphone application for STI prevention strategies (information exchange between users and a behaviour-based risk calculator do not constitute a medical purpose, so it is not a medical device) and medical calculators (calculating scores such as CHA2DS2-VASc goes beyond simple search, so the product is a medical device, classified at least class IIa under Rule 11). Cases added in Version 5 include packaging for administering a medicinal product, a penis holster, a syringe containing glass beads, needles for root canal irrigation and saline solutions for nasal irrigation. The manual is to be read with MDCG 2019-11 (software qualification and classification), MDCG 2021-24, MDCG 2022-5 and other guidance. It is not legally binding, does not reflect the official position of the European Commission, and decisions on individual products remain with national competent authorities.

Background note explaining that the manual on borderline and classification issued in May 2019 under the old medical device Directives (such as 93/42/EEC) remains available as a reference resource even after the new manual under the MDR (Regulation (EU) 2017/745) and IVDR (Regulation (EU) 2017/746) became operative in September 2022. It applies for as long as devices CE-marked under the old Directives remain on the market, and is maintained by the Borderline and Classification Working Group (BCWG) under the MDCG. It is non-binding guidance.

Revision 1 of MDCG 2021-24 (guidance on classification of medical devices under the EU MDR), published 20 April 2026. It clarifies terminology by replacing the word "surgical" with "clinical" in the invasiveness definition, and updates the tables and practical notes for Classification Rules 2, 8, 9, 10, 12, 16 and 22. Based on the sources reviewed, the software classification rule (Rule 11) itself was not amended in this revision.

FAQ-style guidance jointly issued by the Medical Device Coordination Group (MDCG) and the AI Board (MDCG 2025-6 / AIB 2025-1, published 19 June 2025) on the interplay between the Medical Devices Regulation (MDR), the In Vitro Diagnostic Medical Devices Regulation (IVDR), and the EU Artificial Intelligence Act (AIA). Addressed to manufacturers, competent authorities, and notified bodies, it explains how AI-specific requirements, such as data governance, algorithmic transparency, performance monitoring, bias mitigation, and human oversight, can be integrated into existing MDR/IVDR technical documentation and a single conformity assessment rather than requiring separate processes. It also touches on post-market surveillance obligations and the use of predetermined change control plans (PCCPs), relevant ahead of the AI Act obligations that are expected to start applying from August 2027.

Guidance (MDCG 2025-4, published 16 June 2025) clarifying the responsibilities of online platforms that make medical device software (MDSW) apps available, and how the MDR, the IVDR, and the Digital Services Act (DSA) interact. Where a platform merely connects a manufacturer with users, it is treated as an online marketplace under the DSA rather than a distributor or importer under the MDR/IVDR, but it still carries DSA obligations such as a mechanism for reporting illegal content, ensuring manufacturers provide transparent safety and compliance information, and, for very large platforms, risk assessment and mitigation. Where a platform itself supplies the app directly to users, it is instead treated as a distributor or importer under the MDR/IVDR, the DSA no longer applies, and the platform must verify compliance and cooperate with authorities. The guidance also recommends that platforms create a dedicated category for MDSW apps, separate from general health and wellness apps, and lists the information manufacturers should provide, including the device name, manufacturer details (including the Single Registration Number, SRN), the MD or IVD symbol, intended purpose, warnings, a link to the electronic instructions for use (eIFU), and the UDI-DI.

Revision 1 of MDCG 2019-11 (published 17 June 2025), the core guidance on qualifying software as a medical device (MDSW) and classifying it under the MDR (Regulation (EU) 2017/745) and the IVDR (Regulation (EU) 2017/746). The revision clarifies the scope of the guidance, adds considerations on establishing a clear intended purpose and on modular MDSW (defining intended purpose at the level of individual functional modules), and clarifies the interpretation of Classification Rule 11 sub-rule (a) concerning devices intended to prevent the risk of illness, with additional reference material and examples. It also adds a new Class I example to Annex IV and updates Annex I to reflect the interplay with the European Health Data Space Regulation.

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.