Newsletter No 32 March 2023
Subject: MDR transitional period extension approved for legacy devices
On 20 March 2023, Regulation (EU) 2023/607 amending Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) has entered in force. This Regulation aims at giving more time to certify medical devices according to MDR to mitigate the risk of shortages.
This amendment only affects legacy devices and keeps unchanged the status of devices class I non-sterile not having measuring function because they are already fully MDR compliant after MDR date of application of 26 May 2021.
Let’s recall the definition of legacy devices:
Legacy devices are devices, which, in accordance with Article 120(3) of the MDR, are placed on the market after the MDR’s date of application (DoA) and until 26 May 2024 if certain conditions are fulfilled. Those devices can be:
- devices which are class I devices under Directive 93/42/EEC (MDD), for which an EC declaration of conformity was drawn up prior to 26 May 2021 and for which the conformity assessment procedure under the MDR requires the involvement of a notified body;
- devices covered by a valid EC certificate issued in accordance with Directive 90/385/EEC (AIMDD) or the MDD prior to 26 May 2021.
Which are the changes?
The changes introduce a gradual extension of the transition period subject to certain conditions and deleting the ‘sell-off’ deadline. Let’s take a closer look:
- Extension of the validity of CE certificates according to Directive 93/42/EEC (MDD)
This extension is directly applicable, and the Notified Bodies (NBs) are not required to change the date on the individual certificates.
The extension periods are:
- 31 December 2027 for high-risk class MDs: class III and class IIb implantable except certain devices for which the MDR provides exemptions for being based on well-established technologies.
- 31 December 2028 for medium and low risk class MDs: class IIb other than devices above, class IIa and class I sterile or having a measuring function.
- Extension of the transitional period under the following conditions:
- Devices must continue to comply with MDD.
- No significant changes are permitted in the design and intended purpose. Reference guidance is MDCG 2020-3.
- MDs must remain safe, so that they do not present an unacceptable risk to health and safety. If decided by the National Competent Authority upon market surveillance activities, transitional period ends for that product.
- MDR-compliant quality management system (QMS) needs to be in place no later than 26 May 2024. No self-declaration or verification by NB is required but by submitting MDR application to a Notified Body (NB) the manufacturer implicitly confirms that its QMS complies with the MDR.
- Formal MDR application for the medical devices or devices intended to substitute that device must be submitted no later than 26 May 2024 and written agreement between the NB and the manufacturer needs to be signed no later than 26 September 2024.
- Clarification on MDD surveillance of legacy devices: it is under responsibility of the NB issuing the MDD certificate. NB for MDR certification will by default become responsible for MDD surveillance when signing the MDR certification contract.
- Deletion of the ‘sell-off’ deadline of 26 May 2025
The ‘sell-off’ date is the end date after which devices that have already been placed on the market before or during the transition periods and remain available for purchase, should be withdrawn.
Which are the changes regarding placing products on the market?
During this extended transitional period, MDD-certified devices that comply with the above conditions can be placed on the market.
Manufacturers that decide not to initiate MDR certification will be excluded from the legacy period extension, therefore they will not be allowed to place MDD-certified devices on the market after 26 May 2024.
In any case, the devices already placed on the market will be allowed to remain in the distribution chain until the end of their shelf life.
A few takeaways for distributors
- All legacy devices already in the distribution chain will be available for sales until the end of the shelf life.
- From 26 May 2024 onwards, ‘legacy’ devices purchased to the manufacturer and therefore placed on the market will require proof of MDR framework agreement signed and MDR application submitted. This proof will need to be provided by the manufacturer.
- Smooth communication between manufacturers and distributors regarding MDR transition are key to ensure product supply during this extended ‘legacy’ period.
Which are the next steps?
Further clarifications may be required given the longer transitional period, for example regarding PRRC role for legacy devices.
Additional guidance will also be needed for the manufacturers and NB to provide proof to the distribution chain, respecting documentary privacy, regarding written signed MDR agreement between the manufacturer and the NB and proof of MDR application submitted.
In STS we will continue our efforts to get updated on the legislative developments and undergo a smooth transition to MDR.
This newsletter is part of our campaign to increase the sensitivity and the awareness of all our business partners, to bring more clarity around the MDR journey and challenges and opportunities around the MDR Art.22 “Systems and Procedure Packs”.
We are already today all dependent on efficient cooperation. For the MDR implementation, we require even closer collaboration to ensure we all can deliver safe supply to hospitals and patients in the future.
We are confident we will continue to supply health care competently on customized surgical procedure sets and small kits.
Do you wish to know more about specific MDR topics? Do you have any questions or comments about STS newsletter? Write us at MDR2020@stsmedicalgroup.com.
The next MDR newsletter will be issued in April. We wish everyone productive and pleasant days.
CEO STS Medical Group
Group Manager Regulatory Affairs
STS Medical Group