On 9 July 2024, the Regulation (EU) 2024/1860 has been published in the Official Journal of the European Union (OJEU) with immediate effect. The objective of the amending Regulation is to address the projected imminent risks of shortages of in vitro diagnostic medical devices in EU due to the slower than anticipated transition from the In Vitro Diagnostic Directive (IVDD) to the IVDR.
In addition to the removal of the sell-off provisions specified in Article 110.4 made official with Regulation (EU) 2023/607 on 20 March 2023, this new Amending Regulation aims to guarantee patient care by ensuring the availability of IVDs, without compromising safety requirements.
The new Amending Regulation extends the IVDR transition timelines while also recognising as valid previously issued IVDD Certificates for the duration of those longer transition timelines. This allows manufacturers to continue placing their devices on the market based on compliance to the Directive and to IVDR Art 110 provisions, while transitioning their devices to the IVDR. However, it is important to note that the extended transition timelines apply only to devices that are transitioning to the IVDR while meeting additional specific conditions set out in the Regulation. These conditions are aimed at ensuring that the manufacturer has taken appropriate steps to transition to the IVDR. A summary of the salient points from the Amending Regulation is outlined in the communication released in July 2024.
BSI implementation of the Amending Regulation
Notified Body confirmation letters for IVDR applications with BSI
In July 2024, the European Commission published the Q&A on practical aspects related to the implementation of the extended transitional period provided for in the IVDR to clarify important requirements with regards to the extension of the transitional periods. The Q&A includes a flowchart that should help to determine the eligibility, conditions and deadlines for the placing on the market or putting into service of certain devices in accordance with IVDR Article 110.
BSI already has a process in place for issuing confirmation letters to those devices that qualify for it and has already issued numerous confirmation letters so far to aid manufacturers to get market access for their qualifying legacy devices. If you need a confirmation letter for your qualifying legacy devices, please contact your Scheme Manager.
Restart/continuation of appropriate surveillance
Manufacturers with Directives certificates (IVDD) issued by BSI and that qualify for benefitting of the extended transition timelines can request the restart/continuation of appropriate surveillance for the relevant legacy devices.
BSI has already a process in place for restarting/continuing appropriate surveillance under the IVD Directive. It is the responsibility of the manufacturer that their qualifying legacy devices receive appropriate surveillance to benefit from the extended transitional timelines. Please contact your Scheme Manager if you intend to restart/continue appropriate surveillance for your qualifying legacy devices.
BSI will stop appropriate surveillance activities at the time of Directive certificate expiry unless the manufacturer requests otherwise.
Transfer of appropriate surveillance
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), the (EU) 2024/1860 Regulation allows the transfer of appropriate surveillance for the relevant legacy devices from the Directive NB to the IVDR NB. No later than 26 September 2025, the IVDR notified body that has signed the IVDR written agreement shall become responsible for the surveillance in respect of the devices covered by the written agreement.
BSI has a process in place for transferring the appropriate surveillance of legacy devices:
- If you have an ongoing IVDR application with BSI and you intend to transfer the appropriate surveillance of any of your legacy devices certified by another NB to BSI, please contact your BSI Sales Representative or Scheme Manager as soon as possible to allow the transfer activities to be completed before the 26 September 2025 deadline defined in the (EU) 2024/1860 Regulation.
- If you have an ongoing IVDR application with another Notified Body and you wish to transfer it to BSI, the EU Commission Q&A - question 7.1, foresees the possibility to transfer, under certain conditions, both the IVDR application and the appropriate surveillance for the relevant legacy devices to another Notified Body after 26 September 2025 or before this deadline if your Directive Certificate expired on or before the 8th of July 2024 and you are benefitting of the extended transition timelines. If you are interested in transferring your IVDR application/certificate and the appropriate surveillance of the related legacy devices, please contact your Scheme Manager (if you’re already a BSI client) or email us at MedicalDevices@bsigroup.com for any additional information.
Non-compliance to the conditions specified in the (EU) 2024/1860 Regulation and impact on legacy devices
Article 110(3c) of IVDR, as amended by the (EU) 2024/1860 Regulation, details the conditions under which legacy devices may be placed on the market or put into service for the extended transitional timelines.
In case of any major non-conformities (NC) raised by the Notified Body in relation to non-compliance with the applicable conditions, the subject legacy device cannot be placed on the market under the relevant Directive as long as the major NC remains open, unless justified otherwise. Similarly, in case of any safety concerns due to an unacceptable risk to the health or safety, the impacted legacy device cannot be placed on the market until such safety concerns are fully addressed.
If, after the 26 May 2025, the QMS as per IVDR requirements has not been implemented or its implementation is found to be ineffective and this leads to a major NC being raised by the Notified Body, all legacy devices under that QMS cannot be placed on the market under the relevant Directive as long as the major NC is open.
Impact of IVDR certification refusals on legacy devices
Question 7.1 in the European Commission Q&A clarifies that if, after the relevant deadlines, the manufacturer withdraws its application for conformity assessment under IVDR or if the Notified Body refuses to issue the IVDR certificate due to non-compliance with the relevant IVDR requirements, then the transitional period ceases to apply for the relevant legacy devices.
Manufacturers recommended to not postpone/delay their IVDR plans
To make full use of the currently available capacity for completing the IVDR transition, BSI strongly recommends that manufacturers who have already made or planned their IVDR applications and documentation submissions with BSI do not deviate from their plans, and strongly urges other manufacturers who are yet to make their IVDR applications to submit them as soon as possible for the following reasons:
- Only those devices transitioning to the IVDR benefit from the longer transition timelines and extended validity of the Directive Certificates for those devices.
- Delaying or changing your current planned submissions will mean that the submissions will be added to the end of the review queue thus facing the risk of delayed conformity assessment.
- Manufacturers are not allowed to make significant changes to the design or intended purpose of their devices under the Directive even under the longer transition timelines.
- For those manufacturers intending to transition their devices to IVDR and that are yet to submit their applications, BSI may not be able to process your application in a timely manner if it is submitted very close to the application cut-off timelines due to the anticipated rush of last-minute applications thus facing the risk of not benefitting from the longer transition timelines.
Technical Documentation work is allocated to reviewers qualified to the specific IVR/IVP/IVS/IVD codes (or combinations thereof) applicable to each submission, so the lead time for allocation and commencement of a review is variable depending on the existing and incoming workloads. We will schedule and conduct reviews at the earliest opportunity based on availability of reviewers. During a review, responding to questions in a timely manner will ensure the cadence of your review schedule is as efficient as possible.
Please be assured we are focusing on our capacity of reviewers to be able to meet the demands for certification as efficiently as possible.
Where can I find additional information?
You can visit our IVDR dedicated webpage to access additional information and resources to support you, along with an IVDR transition guidance and our Q&A on most frequently asked questions. If you have additional questions, please contact your Scheme Manager/Sales Representative (if you’re already a BSI client) or email us at MedicalDevices@bsigroup.com for any additional information.
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 Regulation transition in a timely manner.
Sincerely,
Alex Laan
Head of IVD Notified Body
Regulatory Services, BSI
Sara Fabi
Regulatory Lead
Regulatory Services, BSI
