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February 6, 2026
Approximately 5 minutes
Extension of EU IVDR Transitional Provisions for In Vitro Diagnostic Medical Devices
Extension of EU IVDR Transitional Provisions for In Vitro Diagnostic Medical Devices
1. Background and Rationale
The In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) became applicable on 26 May 2022, replacing Directive 98/79/EC. Due to challenges including the COVID-19 pandemic, supply chain disruptions, insufficient notified bodies, and delays in reference laboratory designations, transitional provisions under Article 110 were extended. The extension was proposed in October 2021 and adopted on 25 January 2022. Source: Danish Medicines Agency IVDR Transitional Extension Page https://laegemiddelstyrelsen.dk/en/devices/new-regulations/extension-of-transitional-provisions-related-to-in-vitro-diagnostic-medical-devices-ivd-/
2. Key Transitional Dates
- Certificates issued before 25 May 2017 (EC verification, Annex VI Directive): Void in 2025.
- Certificates issued by notified body after 25 May 2017 (Directive): Void no later than 27 May 2025.
- For IVDs not requiring notified body under Directive but requiring under Regulation, with declaration of conformity before 26 May 2022:
- Class D: Place on market/put into service until 26 May 2025.
- Class C: Until 26 May 2026.
- Class B and sterile Class A: Until 26 May 2027.
- IVDs lawfully placed on market from 26 May 2022: May continue to be made available until the above dates. Source: Danish Medicines Agency IVDR Transitional Extension Page https://laegemiddelstyrelsen.dk/en/devices/new-regulations/extension-of-transitional-provisions-related-to-in-vitro-diagnostic-medical-devices-ivd-/
3. In-House IVDs (Article 5(5))
For IVDs manufactured and used only within health institutions:
- Points (b) and (c): Apply from 26 May 2024.
- Points (e) to (i): Apply from 26 May 2024.
- Point (d): Applies from 26 May 2028 (extended).
- Condition in point (d): No longer applies from 26 May 2028, but from 31 December 2030. Source: Danish Medicines Agency IVDR Transitional Extension Page https://laegemiddelstyrelsen.dk/en/devices/new-regulations/extension-of-transitional-provisions-related-to-in-vitro-diagnostic-medical-devices-ivd-/
4. Eligibility Conditions
Transitional provisions apply to:
- IVDs with Directive certificates becoming void.
- IVDs without prior notified body involvement but now requiring it, with declaration of conformity before 26 May 2022. New IVDs certified after 26 May 2022 must fully comply with IVDR. Source: Danish Medicines Agency IVDR Transitional Extension Page https://laegemiddelstyrelsen.dk/en/devices/new-regulations/extension-of-transitional-provisions-related-to-in-vitro-diagnostic-medical-devices-ivd-/
5. Implications
The extensions prevent supply shortages, maintain patient access to safe IVDs, and allow gradual implementation of stricter requirements. Manufacturers must monitor certificate validity and prepare for full IVDR compliance. Official reference: Regulation (EU) 2022/234 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv%3AOJ.L_.2022.019.01.0003.01.ENG&toc=OJ%3AL%3A2022%3A019%3ATOC Source: Danish Medicines Agency IVDR Transitional Extension Page https://laegemiddelstyrelsen.dk/en/devices/new-regulations/extension-of-transitional-provisions-related-to-in-vitro-diagnostic-medical-devices-ivd-/
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