5 February 2024
Dear Client,
On 20 March 2023, the Regulation (EU) 2023/607 amending the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (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 the 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 recognising as valid previously issued Medical Device Directive (MDD)/ Active Implantable Medical Device Directive (AIMDD) certificates for the duration of those extended transition timelines. This allowed 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 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 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 the communication sent on 20 March 2023.
BSI implementation of the amending Regulation
NB confirmation letters for MDR applications
In late August, the EU Commission published a flowchart to identify whether or not a device is covered by the extended transitional period. The flowchart 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 MDR Article 120.
BSI already has a process in place for issuing confirmation letters to those devices that qualify for it and has issued hundreds of confirmation letters so far to aid manufacturers 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 (MDD, AIMDD) issued by BSI and that qualify for benefitting from the extended transition timelines can request the restart/continuation of appropriate surveillance for the relevant legacy devices.
BSI already has a process in place for restarting/continuing appropriate surveillance under the applicable Directives (MDD, AIMDD). It is the responsibility of the manufacturer that their qualifying legacy devices receive appropriate surveillance in order 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 the Directive certificate expiry unless the manufacturer requests otherwise.
Transfer of appropriate surveillance
In case the that issued the certificate (Directive NB) is different from the NB with whom the manufacturer signed the MDR written agreement (MDR NB), the (EU) 2023/607 Regulation allows the transfer of appropriate surveillance for the relevant legacy devices from the NB to the MDR NB. The transfer of appropriate surveillance to the MDR NB must be completed no later than 26 September 2024.
BSI has a process in place for transferring the appropriate surveillance of legacy devices. If you intend to transfer the appropriate surveillance of any of your legacy devices certified by another NB to BSI, please contact your BSI as soon as possible to allow the transfer activities to be completed before the 26 September 2024 deadline defined in the (EU) 2023/607 Regulation.
Non-compliance to the conditions specified in the (EU) 2023/607 regulation and impact on legacy devices
Article 120(3c) of MDR, as amended by the (EU) 2023/607 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. Similarly, in case of any safety concerns due to an unacceptable risk to health or safety, the impacted legacy device cannot be placed on the market until such safety concerns are fully addressed.
If, after 26 May 2024, the Quality Management System (QMS) as per MDR requirements has not been implemented or its implementation is found to be ineffective and this leads to a major NC (non-conformity) 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 MDR certification refusals on legacy devices
In July 2023, the European Commission updated the Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607.
Question 9.1 in the Q&A clarifies that if, after the relevant deadlines, the manufacturer withdraws its application for conformity assessment under MDR or if the Notified Body refuses to issue the MDR certificate due to non-compliance with the relevant MDR requirements, then the transitional period ceases to apply for the relevant legacy devices.
Manufacturers are recommended to not postpone/delay their MDR plans
While additional time is now available for completing the MDR transition, BSI strongly recommends that manufacturers, who have already made or planned their MDR applications and documentation submissions with BSI, not to deviate from their plans and to submit the MDR 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 take into account the applicable ends of the transitional period for their legacy devices and average certification timelines, and, accordingly, submit their MDR Technical Documentation to the NB allowing sufficient time for the conformity assessment activities to be completed.
BSI strongly urges other manufacturers who are yet to make their MDR applications to submit them as soon as possible for the following reasons:
- Only those devices transitioning to the MDR benefit from the extended transition timelines (up to the end of 2027/2028) and extended validity of the .
- Delaying or changing your current planned submissions will mean that your 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 Directives even under the extended transition timelines.
- For those manufacturers intending to transition their devices to MDR 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 26 May 2024 application cut-off timeline due to the anticipated rush of last-minute applications, thus facing the risk of not benefitting from the extended transition timelines (up to the end of 2027/2028).
assessment work is allocated to reviewers qualified to the specific codes (or combinations thereof) applicable to each submission. Therefore, 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 the 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 focused on increasing our capacity to be able to meet the demands for certification as efficiently as possible.
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.
If you have additional questions, please contact your .
Our priority remains to maintain patient safety and ensure compliant conformity assessments for all products within the new regulatory framework.
BSI would like to thank you for all your efforts and the progress made over the last few years and looks forward to working with you in completing your transitions in a timely manner.
Sincerely,
Maddalena Pinsi, Regulatory Lead Regulatory Services, BSI
