Manufacturers of Class C self-declared IVDs are required to sign a formal written agreement with a Notified Body, if they wish to continue placing their legacy devices on the EU market.
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 recognizing 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.
According to Regulation (EU) 2024/1860, in order to benefit from the extended transition timelines and continue placing legacy medical devices on the market, the manufacturer must meet specific conditions as per amended article 110 of the IVDR. As per compliance requirements to (EU) 2024/1860, no later than 26 September 2026 manufacturers of Class C self-declared IVDs must sign a written agreement with a Notified Body to continue placing their legacy devices on the EU market until 31 December 2028. We encourage you to apply with BSI as soon as possible and well in advance of the deadline. We encourage you to complete all the necessary steps with BSI as soon as possible and not to wait until 26 September to sign an IVDR written agreement.
Transfer of IVDR application for legacy devices
Even after May and September applicable transition deadlines, you can transfer your IVDR application to BSI maintaining your transition regulatory status.
If your legacy device requires appropriate surveillance conducted by a Notified Body, this will be also transferred together with your 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.
In case you have additional questions, if you are a client please contact your Scheme Manager. If you are interested in applying or transferring your IVDR application to BSI, contact us at medicaldevices@bsigroup.com.
Our priority remains to maintain patient safety and ensure compliant conformity assessments for all products within the new regulatory framework.
Sincerely,
Alex Laan,
Head of IVD Notified Body, BSI
Sara Fabi
IVD Regulatory Lead, BSI
