1. Certificates Validity Extension
Certificates issued under Directive 98/79/EC (IVDD) that were valid on 26 May 2022 will now remain valid until 31 December 2027.
Certificates that expired before 9 July 2024 will also be considered valid until 31 December 2027, provided one of the following conditions is met:
- A conformity assessment agreement is signed with a notified body before the certificate's expiry.
- A competent authority grants a derogation or requires the conformity assessment procedure.
2. Extended Transitional Periods
Devices covered by IVDD that do not require a notified body under IVDD but require one under IVDR are subject to the following extended transitional periods:
- Class D devices: Allowed on the market until 31 December 2027.
- Class C devices: Allowed on the market until 31 December 2028.
- Class B devices and Class A (sterile) devices: Allowed on the market until 31 December 2029.
3. Conditions for Transitional Periods
Devices must meet the following conditions to benefit from the extended timelines:
- Compliance with Directive 98/79/EC (no significant changes in design or intended purpose).
- No unacceptable risks to health or safety.
- Implementation of a quality management system by 26 May 2025.
- Submission of a formal application to a notified body for conformity assessment by:
- 26 May 2025: Class D devices.
- 26 May 2026: Class C devices.
- 26 May 2027: Class B and Class A sterile devices.
- Signing of a written agreement with a notified body by:
- 26 September 2025: Class D devices.
- 26 September 2026: Class C devices.
- 26 September 2027: Class B and Class A sterile devices.
4. Post-Market Surveillance
During the extended transitional periods, legacy devices must comply with IVDR requirements for:
- Post-market surveillance.
- Market surveillance.
- Vigilance reporting.
- Registration of economic operators and devices.
5. Notified Body Responsibilities
The notified body issuing the IVDD certificate continues surveillance until 26 September 2025 or until the new notified body agreement comes into effect.
Surveillance responsibilities transition to the notified body designated under IVDR upon signing a new agreement.
6. Deadlines for EUDAMED Registration
Manufacturers must ensure legacy devices are registered in EUDAMED as per the following deadlines:
- 6 months after the functional readiness of EUDAMED: For devices covered under the IVDD certificate.
- 12 months after the functional readiness of EUDAMED: For notified bodies to enter certificate information into EUDAMED.
Conclusion
These amendments aim to prevent device shortages and ensure smooth market access for critical in vitro diagnostic devices. Manufacturers and economic operators must act promptly to meet the revised timelines, ensuring compliance while maintaining a stable supply of diagnostic devices.
