This is the inaugural issue of a new quarterly series designed to keep you informed on the most relevant regulatory developments shaping the MedTech landscape.
Key developments shaping the regulatory landscape
From breakthrough device pathways to major MDR/IVDR simplification proposals, Q1 2026 brings significant regulatory changes that may directly impact manufacturers’ compliance strategies, clinical evidence expectations, and market access activities.
Key Highlights
New Breakthrough Device (BtX) framework launched in the EU
Accelerated pathways and prioritised support for high-innovation medical technologies addressing unmet medical needs.
MDR/IVDR simplification proposal published
Potential reduction of administrative burden, removal of fixed certificate expiration dates, and more flexible clinical evidence requirements.
Post-Market Surveillance expectations reinforced
Manufacturers are expected to implement increasingly proactive PMS systems with stronger integration into risk management and clinical evaluation activities.
Clinical and standards updates impacting manufacturers
New harmonised standards and ISO revisions introduce updated expectations for clinical investigations, labelling, sterilisation, and Software as a Medical Device (SaMD).
Expanded Well-Established Technologies (WET) exemptions
Additional implantable and Class III devices may now benefit from exemptions from clinical investigations under MDR.
What should manufacturers do now?
- Review PMS procedures to ensure proactive data collection and integration with clinical evaluation and risk management documentation.
- Assess whether products may qualify for BtX designation or benefit from new WET exemptions.
- Evaluate the impact of updated harmonised standards and ISO revisions on technical documentation, IFUs, and clinical investigation processes.
- Monitor the progress of the MDR/IVDR simplification proposal and prepare for potential regulatory transition opportunities.
- Verify alignment of labelling, PMCF/PMPF, and clinical evidence strategies with the latest MDCG and ISO expectations.
Have a look at the complete document here: MEDTECH_NEWSLETTER
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