Revised MDCG classification and borderline guidance
- Date
- April 23, 2026
- Category
EU Regulations
- Description
In April 2026, the MDCG updated two useful guidance documents: MDCG 2021-24 Rev.1 on classification of medical devices and Version 5 of the Borderline and Classification Manual. While both documents are not legally binding, they provide a helpful view of current regulatory thinking under the MDR and IVDR.
MDCG 2021-24 Rev.1 mainly brings clarifications rather than major changes. The update includes revised wording on implantable devices, clearer references to Annex XVI products, and updates to selected rules, especially Rules 8, 10, 12, 16 and 22. One important clarification is that the guidance now refers more clearly to “clinical” procedures, not only surgical ones, when explaining implantable devices. This may be relevant for products placed through non-surgical clinical interventions.
The updated Borderline and Classification Manual adds several new practical examples. These include a device used to administer a medicinal product, saline solutions for nasal irrigation, root canal irrigation needles, and a syringe containing glass beads. The most relevant takeaways are more clarity on Article 117 / integral drug-device products and additional guidance for implantables and spinal products under Rule 8. For IVD manufacturers, the update is more limited. The Borderline Manual still contains relatively little detailed IVDR case content.
Manufacturers, particularly those of implantable devices, substance-based devices, borderline products, and products combined with medicinal products, are advised to revisit their classification rationale and supporting technical documentation.
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