MDCG 2024-16: MDR/IVDR Article 10(a) Manufacturer Form to Report Supply Disruptions
6 December 2024
EU Commission: New Consultation Opened to Collect Feedback and Evaluate the MDR/IVDR
12 December 2024Overview
The roadmap is available: HERE
It outlines that:
- The new Post-Market Surveillance (PMS) regulation is expected to become mandatory mid-2025.
- The new Pre-Market Requirements (e.g., International Reliance, IVD reclassification, UDI, etc.) are expected to be introduced to Parliament late 2025 and in force early 2026.
- New policy development (e.g., early access for innovative devices) is expected to be developed and published mid-2025.
- New guidance for Software, including AI and digital mental health products, is expected in 2025 (either published for comment, or as final guidance).
As noted in the PDF, it is a ‘living’ document and is therefore subject to changes.
