Even before coming into effect on 26 May 2021, calls for extensions to transitional timelines provided for under Article 120 of the Medical Devices Regulation (EU) 2017/745 (MDR) were growing. In the nearly two years since, and just over a year out from the original deadline of 26 May 2024, EU legislators have recognised the pressing need to address the imminent risk of shortages of essential medical devices in the EU by publishing a new Implementing Regulation that amends the MDR and provides manufacturers with more time to certify their devices as MDR-compliant.
Extended timelines
Device class under MDR |
Deadline |
Class III custom-made implantable devices |
26 May 2026 |
Class III, or Class IIb implantable devices excluding ‘well-established technologies’ (WET) |
31 December 2027 |
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 |
31 December 2028 |
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 (Example: the majority of software medical devices, now classified under MDR, Annex VIII, Rule 11) |
31 December 2028 |
Conditions
Although the extended timelines do provide extra breathing room to manufacturers and notified bodies, effective transitioning to the MDR remains the objective. Accordingly, extra time is only available to manufacturers who satisfy various specific conditions. Manufacturers availing of the extended timelines must:
- Lodge an MDR conformity assessment application and sign a formal agreement for conformity assessment services with a notified body by 26 May 2024 and 26 September 2024 respectively
- Have an MDR-compliant quality management system in place on or before 26 May 2024
- Ensure that the relevant device(s) continue to comply with the requirements of the Medical Device Directive (MDD) or the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD)
- Ensure that no significant changes are made to the design or intended purpose of the relevant device(s)
- Ensure that the relevant device(s) do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health
MDR post-market surveillance, market surveillance, vigilance and registration requirements also continue to apply to devices subject to transitional provisions.
Sell off provisions
As an added step to ensure a continued supply of essential medical devices on the EU market, ‘sell-off’ provisions in both the MDR (and In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR)) have also now been removed. These provisions previously prevented devices already placed on the market from remaining on the market beyond a certain point. With the recent amendments, these devices can now continue to be made available until the revised expiry of the device certificate or the shelf life of the device.
Notified bodies
Enhancing the capacity of a limited number of designated notified bodies processing a surge in demand for conformity assessment services has been identified as a key part of completing the transition to the MDR. The EU Medical Device Coordination Group (MDCG) has proposed various solutions and actions in a position paper published in August 2022 (MDCG 2022-14). The European Commission has recently acted on one of these proposals by publishing a Delegated Regulation that resets the frequency that notified bodies themselves are reassessed under the MDR to five years.
UK, Northern Ireland and Switzerland
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued a statement regarding the extension of EU certification timelines and CE-marking, which confirms that:
- The changes to the MDR will apply automatically in Northern Ireland under the terms of the Northern Ireland Protocol
- MDD and AIMD certificates that have been extended will also be recognised as valid for placing CE marked devices on the GB market and MHRA registration guidance will be updated to reflect this change
The Swiss Federal Council also intends to update relevant Swiss legislation in order to maintain alignment with the updated MDR provisions. These amendments to the Medical Devices Ordinance (MedDO) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO) are currently planned for Autumn 2023.
Conclusion
Although extended timelines are a welcome development, manufacturers should maintain their efforts to certify their devices under the MDR as soon as possible. It is important to remember that extra time has only been provided to accommodate an existing backlog, and many notified bodies already have heavily oversubscribed application processes for both existing and new clients, as well as growing lead times for allocation of suitably qualified reviewers carrying out assessment projects to tight deadlines.
Manufacturers therefore need to proactively engage with their planned or existing notified body regarding quality management systems (QMS) certification and the lodging of an application for conformity assessment services before May 2024, and ready their MDR technical documentation for assessment while maintaining compliance with transitional requirements in the meantime.
For more information on the application of the MDR and how it impacts your organisation, contact a member of our Life Sciences Regulatory team.
The content of this article is provided for information purposes only and does not constitute legal or other advice.
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