Manufacturers are required to put in place an IVDR compliant QMS and formally apply to a Notified Body under IVDR, if they wish to benefit from the extended timelines.
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 in-vitro diagnostic medical devices in EU due to the slower than anticipated transition from the in-vitro diagnostic devices 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 allowed manufacturers to continue placing their devices on the market based on compliance to 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 will require manufacturers to meet specific conditions set out in the Regulation. These conditions are aimed at ensuring that the manufacturer has intentionally taken steps to transition to the IVDR. A summary of the main points from the new Amending Regulation is outlined in the communication sent in July 2024.
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 the amended article 110 of the IVDR. Among these conditions, no later than 26 May 2025, the manufacturer shall put in place a quality management system in accordance with IVDR Article 10(8) and the manufacturer or the Authorised Representative must lodge a formal application with a notified body for IVDR conformity assessment. Be aware that, at the time of application under IVDR, certain QMS documents shall be provided as per the applicable Annex (e.g., Annex IX, Section 2.1) as well as a plan for Technical Documentation submission.
The impact on legacy devices due to non-compliance to such conditions is described in the communication sent in February 2025. It is the responsibility of the manufacturer to take relevant actions, including stopping to place the affected legacy devices on the market, if one or more of the conditions are not complied with.
Manufacturers are recommended to not postpone/delay their IVDR plans.
Please note manufacturers with Directives certificates (IVDD) issued by BSI and that qualify for benefitting from the extended transition timelines should request the restart/continuation of appropriate surveillance for the relevant legacy devices if they wish to keep placing those devices on the market.
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, meaning devices will no longer meet the Amending Regulation requirements and cannot be placed on the market after the expiry date.
While additional time is now available for completing the IVDR transition, BSI strongly recommends that manufacturers who have already made or planned their IVDR applications and documentation submissions with BSI, to not deviate from their plans and to submit the IVDR Technical Documentation promptly. Manufacturers can refer to the dashboard published by the European Commission on “Monitoring of availability of medical devices on the EU market” for determining the average certification timelines under the different conformity assessment routes. It is the manufacturer’s responsibility to submit their IVDR Technical Documentation to the Notified Body allowing sufficient time to complete the conformity assessment activities considering the applicable transitional timelines and the average certification timelines. Finally, BSI recommends that any pending IVDR applications for legacy devices be submitted without any further delay as we are fast approaching the 26 May 2025 deadline.
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 and a FAQ document with answers to most frequently asked questions in relation to this Regulation and associated topics. If you have additional questions, please 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
