March 20 2023: 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 new amending Regulation extends the MDR transition timelines while also recognising as valid previously issued MDD, AIMDD 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 Directives while they continue the transition of their devices to the MDR. However, it is important to note that the longer transition timelines 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 salient points from the new amending Regulation is outlined below.
Key elements of the new amending Regulation
The table below shows the new transition timelines that apply for different categories of devices subject to the manufacturer submitting an MDR application by the 26 May 2024 and having a signed formal written agreement with a Notified Body by the 26 Sep 2024, and meeting other conditions (see the dedicated FAQ document) set out in the Regulation:
| Transition timelines |
Devices |
| 26 May 2026 |
Class III custom-made implantable devices |
| 31 December 2027 |
Devices covered by valid MDD/AIMDD Certificates (as of 2023/03/20 and that are Class III, or Class IIb implantable devices excluding well-established technologies (WET)* under MDR |
| 31 December 2028 |
Devices covered by valid MDD/AIMDD Certificates (as of 2023/03/20) and that are Class IIb devices (excluding Class IIb implantable non-WET), or Class IIa devices, or Class I sterile devices or Class I devices with a measuring function;
Devices that did not require Notified Body certification under the MDD and for which the declaration of conformity was drawn up prior to 26 May 2021, but now require Notified Body certification under the MDR
|
*Well-established technologies (WET): sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors.
Devices covered by MDD/AIMDD Certificates that were valid as of 26 May 2021, but expired prior to the publication of this new amending Regulation benefit from the longer transition timelines (as shown in the table above) only if the manufacturer had applied for MDR and signed a formal written agreement prior to the expiry of those Directive Certificates or a derogation/exemption has been granted by a Competent Authority under either Article 59(1) or Article 97(1) of the MDR.
The sell-off provisions specified in MDR Article 120.4 have been abolished to allow medical devices already placed on the market under the Directives to be made further available without an end date.
In cases where the manufacturer has their MDR application with a different Notified Body to the one that issued the Directive Certificate, the Regulation allows the MDR Notified Body to take over the appropriate surveillance of the devices covered the Directive Certificates issued by the other Notified Body, subject to an agreement between the two Notified Bodies and the manufacturer.
BSI plans on implementing the new amending Regulation
BSI welcomes the new amending Regulation as it ensures market access to safe medical devices while providing additional time to manufacturers and Notified Bodies to complete the transition of their devices to the MDR. The additional time also provides opportunities to help more manufacturers bring their innovative devices to the EU market.
BSI has already started work to implement the new amending Regulation into our own Quality Management System and operational processes and expects to complete these activities as soon as possible but in a phased manner depending on the priority of the changes/provisions to be implemented. In parallel, BSI is also working very closely with the EU Authorities, and other Notified Bodies to develop a common understanding of the Regulation, develop relevant templates and support harmonized implementation of the new amending Regulation across all Notified Bodies.
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 do not deviate from their plans, and 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 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 Directives even under the longer transition timelines
- For those manufacturers intending to transition their devices to MDR and 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 assessment work is allocated to reviewers qualified to the specific MDA/MDN/MDS 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 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 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 MDR dedicated webpage to access additional resources to support you, along with a FAQ document with answers to most frequently asked questions in relation to this Regulation and associated topics.
We have also scheduled a webinar on the March 29 2023 where we will cover this Regulation and BSI implementation plans in more detail. Please register here.
If you have additional questions, please contact your Scheme Manager.
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 Regulation transitions in a timely manner.
Sincerely,
Jayanth Katta
Head of the Medical Devices Notified Body
