July “In All Other News”: MDR/IVDR Reform, UK to Align with EU IVD Common Specifications, Team-NB MDR Training, and more
5 August 2025
swissdamed Device Module Opens for Voluntary Use, New SPP Guidance, and eIFU & MIR Form Updates
15 August 2025Background
In December 2024, the European Commission launched a targeted evaluation of the MDR and IVDR. Its purpose was to assess whether the Regulations are meeting their objectives.
Stakeholders were invited to share input on issues like device availability, capacity for innovation, and administrative and financial burdens (particularly to small-to-medium sized enterprises).
The consultation closed 21 March 2025, and the results were published this past June.
Overview of the New Consultation
The Commission opened a new, yet related, “Have Your Say” initiative: HERE
It reflects the next phase, which is to:
- Analyze stakeholder feedback (including responses gathered through other channels, e.g., the European Parliament), and
- Outline proposed revisions to better “simplify EU rules for medical devices and in vitro diagnostics” and “ensure availability of safe and innovative devices”.
Nothing new is truly known yet. However, the Commission has indicated it intends to share initial proposals by December 2025. Stay tuned; Casus will be monitoring closely.
