IVDD certified devices and Class D self-declared devices manufacturers to sign the written agreement with a Notified Body
On 9th July 2024, the Regulation (EU) 2024/1860 amending the MDR and IVDR was published in the Official Journal of the European Union (OJEU) with immediate effect. One of the objectives of the Amending Regulation is to address the projected imminent risks of shortages of medical devices in EU due to the slower than anticipated transition from the In-Vitro Medical Device Directives to IVDR.
The amending Regulation extended the IVDR transition timelines while also recognising as valid previously issued IVDD certificates for the duration of those extended transition timelines. This allows manufacturers to continue placing their devices on the market based on compliance with the Directives while they continue the transition of their devices to the IVDR. However, it is important to note that the longer transition timelines (up to the end of 2027/2028/2029) apply only to devices that are transitioning to the IVDR and meet other specific conditions set out in the Regulation. These conditions are aimed at ensuring that the manufacturer has taken steps to transition to the IVDR. A summary of the main points from the new Amending Regulation is outlined in our IVDR transition guidance, FAQ and Surveillance Transfer Guidance.
26 September 2025 deadline for signing the IVDR written agreement and completing transfer of appropriate surveillance
Among the conditions set out in the amended IVDR Article 110, 26 September 2025 is the deadline for manufacturers of legacy devices covered by an IVDD certificate and of legacy devices up-classified as Class D under the IVDR to sign a written agreement under the IVDR. This is also the deadline to transfer appropriate surveillance of IVDD certified devices, where needed and applicable.
In case the Notified Body that issued the Directive certificate (Directive NB) is different from the Notified Body with whom the manufacturer signed the IVDR written agreement (IVDR NB), Article 110.3e of the IVDR allows the transfer of appropriate surveillance for the relevant legacy devices from the Directive NB to the IVDR NB. The IVDR NB shall become responsible for the appropriate surveillance for the relevant legacy devices no later than the 26 September 2025.
Transfer of IVDR application and appropriate surveillance for legacy devices
Question 7.1 of the Commission Q&A foresees the possibility for manufacturers to transfer the IVDR application from a Notified Body to another one even after the 26 September 2025, without impacting the eligibility of the legacy devices to benefit from the extended transition timelines, under certain conditions. The appropriate surveillance of the relevant legacy devices the manufacturer intends to keep placing on the market is transferred along with the transfer of the IVDR application.
BSI currently has no capacity restrictions and has published its lead times for IVDR conformity assessments, to increase transparency and to help the whole process be more predictable for manufacturers.
Where can I find additional information?
You can visit our IVDR dedicated webpage to access additional resources to support you, along with our IVDR transition guidance, FAQ document with answers to the most frequently asked questions in relation to this Regulation and associated topics. See also our Surveillance Transfer Guidance.
If you have additional questions, please send an email to medicaldevices@bsigroup.com.
Our priority remains to maintain patient safety and ensure compliant conformity assessments for all products within the new regulatory framework.
We look forward to working with you in completing your IVDR transition in a timely manner.
Sincerely,
Alex Laan,
Head of IVD Notified Body, BSI
Sara Fabi
IVD Regulatory Lead, BSI
