The third issue of our quarterly series brings together some of the most relevant regulatory developments shaping the MedTech landscape.
Key developments shaping the regulatory landscape
From new requirements for Swiss device registration to updated guidance on UDI responsibilities, IVD classification and biological evaluation, Q3 2026 brings important regulatory developments that may directly impact manufacturers’ compliance strategies, product portfolios and market access planning.
Key Highlights
- Mandatory SWISSDAMED registration: From 1 July 2026, manufacturers and authorised representatives must register medical devices and IVDs placed on the Swiss market in the new UDI Devices module, replacing previous notification procedures.
- New ISO guidance for AI-enabled medical devices: ISO/TS 24971-2:2026 introduces specific guidance on managing risks associated with machine learning-enabled medical devices, reinforcing the need for robust risk management throughout the product lifecycle.
- MDCG 2026-5 clarifies UDI responsibilities: New guidance addresses UDI assignment when distributors relabel or repackage devices, highlighting the importance of clear responsibilities, quality agreements and traceability.
- Updated IVDR Rule 7 classification guidance: MDCG 2020-16 Rev.5 clarifies the classification of IVD controls, particularly the distinction between controls with and without manufacturer-assigned values.
- ISO 10993-3:2026 published: The revised standard strengthens the risk-based approach to biological evaluation, placing greater emphasis on chemical characterisation and toxicological assessment when determining the need for additional testing.
- New AEMPS procedure for in-house IVDs: Spanish healthcare institutions can now submit prior notifications for in-house IVD manufacturing through a transitional procedure, while existing IVDR and national requirements remain applicable.
Have a look at the complete document here: MEDTECH NEWSLETTER Q3 2026
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