In April 2026, the European Commission issued new versions of several guidance documents for compliance of medical devices and IVDs with the EU MDR and IVDR. These include:
- Manual on borderline and classification (version 5)
- Guidance on classification of medical devices (revision 1)
- FAQ on the European Medical Device Nomenclature (revision 2)
- Q&A Obligation to inform in case of interruption or discontinuation of supply (revision 2)
- Article 10a Decision tree (new)
- New XDS and XSL files for reporting forms
Classification of medical devices and IVDs: revised guidance documents
Two revised guidance documents were released in April 2026. The updated version of the Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 and Regulation (EU) 2017/746 includes new sections on:
- Device used intended to administer a medicinal product
- Penis holster
- Syringe containing glass beads
- Needles for root canal irrigation
- Saline solutions for nasal irrigation
The first revision of MDCG 2021-24 guidance on classification of medical devices introduces terminological clarifications, structural alignment, and additional explanatory content. One of the most consequential changes is the replacement of the word “surgical” with “clinical” when describing procedures linked to implantable devices. In addition, the revised guidance introduces two new explanatory notes under Rule 8, addressing practical classification questions for long‑term and implantable devices. The April 2026 revision also reorganises the section related to Rule 9 (active devices) so that the guidance layout follows the structure of the MDR rule more closely. In certain interpretative sections, the term “device” is replaced with “product”.
Revised FAQ on EMDN
Obligation to inform in case of interruption or discontinuation of supply
The April 2026 update (Revision 2) mainly adds practical decision support to Article 10a MDR/IVDR. The key new element is the introduction of a decision tree, which helps manufacturers assess whether a supply situation qualifies as an interruption or discontinuation that requires notification. In addition, the revised Q&A expands and clarifies the assessment criteria (notably in Q9), explaining which indicators should be considered when evaluating the potential risk of serious harm to patients or public health.
The legal obligation itself does not change; the update simply translates Article 10a into a clearer, more consistent risk‑based assessment framework to support harmonised application in practice.
New for XDS and XSL files for reporting forms
Lastly, in April the European Commission released new manufacturer incident report files (XSD files and XSL files).
For any questions on compliance of your medical devices, contact MDlaw Team here or at mdlaw@obelis.net.
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