The second 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 expanded MDR exemptions to new coordinated pathways for combined studies and increasing focus on regulatory data governance, Q2 2026 brings important changes that may directly impact manufacturers’ compliance strategies, clinical planning and operational readiness.
Key Highlights
- Expanded WET exemptions under MDR: the European Commission has expanded the categories of well-established technologies, reducing the clinical and technical documentation burden for certain mature devices.
- COMBINE Phase 2 launched: a new coordinated pathway aims to streamline assessments for combined studies involving medicines and medical devices or IVDs.
- Mandatory EUDAMED / RECOPS readiness: RECOPS in Spain reinforces the need for complete, accurate and aligned regulatory data before notification can be completed.
- ISO 10993-7:2026 published: updated requirements strengthen expectations for EO sterilisation residuals.
- AI Act integration for MDAI: high-risk medical device software must incorporate new requirements such as logging, robustness and human oversight into existing MDR/IVDR systems.
Have a look at the complete document here: MEDTECH NEWSLETTER Q2 2026
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