On 20 March 2023, the Regulation (EU) 2023/607 amending the MDR and IVDR was 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 medical devices in EU due to the slower than anticipated transition from the Medical Device Directives to MDR and IVDR.
The amending Regulation extended the MDR transition timelines while also recognizing as valid previously issued MDD/AIMDD certificates for the duration of those extended transition timelines. This allows 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 MDR. However, it is important to note that the longer transition timelines (up to the end of 2027/2028) apply only to devices that are transitioning to the MDR 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 MDR. A summary of the main points from the new Amending Regulation is outlined in our 29th March 2023 webinar.
26 September 2024 deadline approaching
Among the conditions set out in the amended MDR Article 120, 26 September 2024 is the deadline for manufacturers to sign a written agreement under the MDR and to transfer appropriate surveillance, where needed. In case the Notified Body (NB) that issued the Directive certificate (Directive NB) is different from the Notified Body with whom the manufacturer signed the MDR written agreement (MDR NB), article 120.3e of the MDR allows the transfer of appropriate surveillance for the relevant legacy devices from the Directive NB to the MDR NB. The MDR NB shall become responsible for the appropriate surveillance for the relevant legacy devices no later than the 26 September 2024.
Transfer of MDR application and appropriate surveillance for legacy devices
Question 9.1. of the Commission Q&A foresees the possibility for manufacturers to transfer the MDR application from a Notified Body to another one even after the 26 September 2024, 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 MDR application.
BSI currently has no capacity restrictions and has published its lead time for MDR 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 MDR dedicated webpage to access additional resources to support you, along with our MDR transition guidance and a FAQ document with answers to the most frequently asked questions in relation to this Regulation and associated topics.
Our priority remains to maintain patient safety and ensure compliant conformity assessments for all products within the new regulatory framework.
Whether you're starting the certification process, looking to transfer or need to discuss your options, we can guide you through the process.
Request a quote today and start your journey with BSI. We look forward to working with you in completing your Regulation transitions in a timely manner.
Sincerely,
Maddalena Pinsi
Associate Head of Medical Devices Notified Body & Senior Regulatory Lead
Regulatory Services, BSI
