The European Commission has confirmed that the updated Manufacturer Incident Report (MIR) form version 7.3.1 will become mandatory from 1st May 2026 for reporting serious incidents under the MDR and IVDR. Manufacturers and Authorized Representatives should already start aligning their vigilance procedures, internal workflows, and IT systems with the new requirements.
In addition, new guidance on Post-Market Surveillance (PMS) activities is available since December with the publication of MDCG 2025-10, further clarifying PMS expectations and reinforcing the link between PMS, vigilance, and regulatory compliance.
👉 Now is the right time to review PMS and vigilance processes to ensure readiness well ahead of the MIR transition deadline. Contact us for support and guidance.
