Publication of Amendments to Regulation (EU) 2024/1860
Publication of Amendments to Regulation (EU) 2024/1860
Regulatory Affairs Medical Devices In Vitro Diagnostics
Thursday, 11 July 2024
Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
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On July 9th, 2024, the European Commission published in the Official Journal of the European Commission (OJEU) Regulation (EU) 2024/1860 amending regulations (EU) 2017/745 or the Medical Device Regulation (MDR) and Regulation (EU) 2017/746 or the in vitro diagnostic medical device regulation (IVDR) as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply and transitional provisions for certain in vitro diagnostic medical devices.
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As a reminder
New IVDR transition timelines
The new transition periods depend on the type of device, specifically its risk class under the IVD Regulation:
- Shorter transition period for high risk (Class D) IVDs (31 December 2027).
- Longer periods for medium and lower risk IVDs, 31 December 2028 for Class C IVDs and 31 December 2029 respectively for Class B and Class A sterile.
Conditions to make use of the transitional provisions
Only legacy devices (devices that were already certified under Directive 98/79/EC or the in vitro diagnostic medical device directive (IVDD)) can make use of the transitional provisions if:
- they continue to comply with IVDD;
- there are no significant changes in the design or intended purpose of the devices;
- the devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health;
- no later than 26 May 2025, the manufacturer puts in place a quality management system compliant with the IVD Regulation;
for devices requiring an assessment by a notified body, the manufacturer submits an application to the notified body to transfer the device to the IVD Regulation by 26 May 2025 (class D), 2026 (class C) or 2027 (class B and A sterile IVDs).
- The manufacturer and the notified body sign a written agreement to proceed with conformity assessment shortly after those dates.
The European Commission also published a Questions and Answers on the practical aspects related to the implementation of Regulation (EU) 2024/1860 on the extension of the In Vitro Diagnostic Regulation transitional periods.
What does it mean to you?
This amending regulation extends the transitional period for certain devices providing IVD manufacturers with more time to transition the existing devices from the IVD Directive 98/79/EC to the IVDR 2017/746. For more information on this amending regulation, please do not hesitate to contact us or refer to our previous newsflash on the proposal, as well as our webinar & whitepaper.
Get in touch with our experts
Should you want to discuss this more in-depth with one of our consultants, please do not hesitate to contact us.
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