As you know, the EU’s Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746) have been fully in force since 2 June 2021. On 9 July 2024, Regulation (EU) 2024/1860 (OJ L 258) introduced additional measures to:
1️⃣ Reduce the risk of market shortages for high-risk IVDs
2️⃣ Phase in EUDAMED modules from Q4 2025 onwards
3️⃣ Require advance notification of any anticipated supply interruptions for certain IVDs
📌 UTS “Product Description” Non-Application Update
By 30 June 2025, all existing IVDs under “IVD-Other” (IVDD 98/79/EC) must update UTS via Non-application Update for Product Description such as:
“Although this product has been placed on the market under the IVD-Other risk class per IVDD 98/79/EC, it will be classified as Class [A/B/C/D] according to IVDR classification rule [X], and we commit to fulfilling all IVDR requirements during the transition period.”
🆕 New or Amended IVD-Other Submissions
• Must include the exact same statement in “Product Description” upon filing.
• Submissions without this text will be rejected.
⚠️ Non-Compliance Measures
• Registrations lacking the update by 30 June 2025 will face corrective actions.
• New filings missing the statement will receive a negative assessment.
⏳ Extended Conformity Assessment Deadlines
• Class D (Personal Test, Point-of-Care & Support Diagnostics): apply by 26 May 2025
Necessary applications must be made in accordance with the Announcement No. 2024/KK-2 for the DoC’s within the scope of IVDD for products whose class will be upgraded from IVD-Other to Class D in accordance with IVDR.
• Class C (Personal Test, Point-of-Care & Support Diagnostics): apply by 26 May 2026
Necessary applications must be made in accordance with the Announcement No. 2024/KK-2 for the DoC’s within the scope of IVDD for products whose class will be upgraded from IVD-Other to Class C in accordance with IVDR.
• Class B&A (Personal Test, Point-of-Care & Support Diagnostics): apply by 26 May 2027
Necessary applications must be made in accordance with the Announcement No. 2024/KK-2 for the DoC’s within the scope of IVDD for products whose class will be upgraded from IVD-Other to Class B&A in accordance with IVDR.
🔗 For full details, please see the original announcement: https://lnkd.in/dMkuKPeF
