Regulation 2023/607 formally extends the Article 120 transitional provisions in the MDR. It also removes the sell-off period from the MDR and IVDR.
The extension allows, under certain criteria:
Certain conditions apply.
If you have not already done so, it is strongly recommended that MDD/AIMDD legacy device manufacturers reach out to Notified Bodies ASAP to request quotes. Notified Bodies are in high demand, and response times for service quotes may be long.
By today, manufacturers of MDD/AIMDD legacy devices must have:
NOTE: Class III implantable custom-made legacy devices are not required to implement an MDR to the QMS by this deadline. However, they are required to have formally lodged an application with a Notified Body by this date.
By today, all MDD/AIMDD legacy device manufacturers must have a signed written agreement with a Notified Body, as per Section 4.3, second subparagraph, of Annex VII.
By today, Class III implantable custom-made devices (CMDs) must comply with the MDR in order to continue being placed on the EU and Swiss markets, i.e., the device must possess a conformity assessment certificate issued by a Notified Body.
The extension period is over for all Class III devices and all Class IIb implantable devices, except for sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, and connectors.
In order to continue placing these devices on the market, they must be CE Marked to the MDR.
MDD legacy devices are no longer recognized. To continue placing these devices on the market, they must be CE Marked to the MDR.
26 May 2026: Class III custom-made implantable devices (CMDs)
31 December 2027: Class III, Class IIb implantable devices, except for sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges
31 December 2028: Class IIb (all other), Class IIa, Class I devices
The following are legacy devices:
If you are in doubt, please consult the MDCG Legacy Device Flowcharts. They help confirm if a device is covered by the extended transition period or not.
NOTE: for custom-made Class III implantable devices, the MDR transition extension (Regulation 2023/607) does not specify any prerequisites, i.e., the extension is available for Custom-made Class III implantable devices, even if the device was not MDD/AIMDD compliant before 26 May 2021 and if the device is newly being placed on the market after the MDR’s date of application.
In order to remain a legacy device, the following criteria must be met:
The device is still eligible for the full legacy device extension, if the following criteria have been met:
All other ongoing requirements for legacy devices apply, e.g., no significant changes allowed to the intended purpose or design.
The EU Commission published a Q&A document, which provides options on how to demonstrate a legacy device is covered by the extension under Regulation 2023/607.
The Q&A document includes links to a template for the Manufacturer’s self-declaration statement and the Notified body’s confirmation letter.
Per MDCG 2020-3 manufacturers may make the following changes without impacting its legacy device status:
Other changes that may impact the design and/or intended purpose, should be assessed on a case-by-case basis.
Examples of changes to the intended purpose/design that do not constitute a significant change include:
Examples of changes to the intended purpose/design that do constitute a significant change include:
MDCG 2020-3 has helpful flowcharts on what may or may not constitute a significant change under the transition provision of the MDR (Article 120(3)). As well, manufacturers can discuss the proposed change with their Notified Body to clarify if it is non-significant under MDR Article 120(3) or if it will push the device into MDR compliance.
The following aspects of the MDR apply to MDD/AIMDD CE Marked legacy devices:
If manufacturers meet the requirements under the first FAQ titled “Which devices qualify as a legacy device under the transition extension”, then the MDD/AIMDD device is considered a legacy device and may continue to be marketed. However, if a manufacturer is not intending to CE Mark to the MDR, then starting 26 May 2024, they will fail to continue to meet the requirements and no longer qualify as a legacy device.
Yes, both Swissmedic and the UK MHRA released announcements that they will recognize the MDR transition period extension granted under EU Regulation 2023/607.
Swissmedic has amended its regulation (MedDo and IvDO) to implement the MDR transition period and removal of the sell-off provision: HERE
The MHRA’s announcement that it will recognize the MDR extension in the UK is available: HERE
The UK is made up of two territories.
For more information on the CE Marking acceptance dates in the UK, please read: UK MHRA Announcement: New Dates for UK Regulation & CE Marking and UKCA Marking: Fact Sheet for Medical Devices & IVDs
MDR/IVDR Legacy Device Change Assessment Tool
Interactive. Free. Easy to Use.
|Legacy devices are subject to the MDR’s market surveillance, post-market surveillance, vigilance, and registration requirements||No change; these same requirements apply under the extension|
|Legacy devices may not undergo significant change to the intended purpose or design; otherwise, the device may be subject to MDR CE Marking||No change; these same requirements apply under the extension|
|If the MDD/AIMDD CE Marking certificate expired before 26 May 2024, that device is off the market unless the manufacturer was granted a derogation by the EU Competent Authorities or obtained MDR CE Marking|
If the following conditions are met, MDD/AIMDD certificates that expired before 20 March 2023 will be considered active and the device may continue to be placed on the market:
1) The CE Certificate was valid on 26 May 2021, and
2) The Certificate was not withdrawn afterwards, and
3a) Before the CE Certificate expired, the manufacturer had a signed written agreement in place with the Notified Body (per MDR Section 4.3, second subparagraph, of Annex VII) and/or
3b) A Competent Authority had granted a derogation in accordance with MDR Article 59(1) or authorization under Article 97(1)
|All MDD/AIMDD legacy devices must be MDR CE Marked by 26 May 2024||The new MDR transition timeline for MDD/AIMDD legacy devices is now:|
– Class III and Class IIb implantable devices require MDR CE Marking by 31 December 2027*
– Class I, IIa and IIb (all other) devices require MDR CE Marking by 31 December 2028**
*Except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors. The timeline for these devices is 31 December 2028
**Class I-self certified devices (non-Notified Body CE Marked) require a Declaration of Conformity that was legally drawn up prior to 26 May 2021
|Legacy device manufacturers were not required to lodge an application with a Notified Body in order to remain qualified as a legacy device||Manufacturers must, no later than 26 May 2024, have lodged an application with a Notified Body for that device, in order to retain its status as a legacy device|
|Legacy device manufacturers were not required to sign an agreement with a Notified Body in order to remain qualified as a legacy device||Manufacturers must, no later than 26 September 2024, have a written agreement in place with a Notified Body for that device, in order to retain its status as a legacy device|
|Legacy devices were not subject to MDR quality system requirements|
Legacy devices are now required, no later than 26 May 2024, to comply with the MDR’s quality system requirements (Article 10(9))
NOTE: Class III implantable custom-made devices are exempt from this requirement
|All custom-made devices must comply with the MDR as of its date of application (26 May 2021) in order to continue being placed on the market|
Class III implantable custom-made devices are now eligible for an extended transition period until: 26 May 2026
NOTE: all other custom-made devices must still comply with the MDR by its date of application to be placed onto the market
MDD/AIMDD legacy devices could no longer be made available or put into service after 26 May 2025
This deadline applied both to devices lawfully placed on the market before or after 26 May 2021
|MDD/AIMDD legacy devices may be made available or put into service indefinitely through the safe use of the device, i.e., the “sell-off” provision originally stipulated in MDR Article 120(4) has been removed|
IVDD legacy devices lawfully placed on the market before 26 May 2022, could no longer be made available or put into service after 26 May 2025
IVDD legacy devices lawfully placed on the market after 26 May 2022, could no longer be made available or put into service after:
– 26 May 2026: Class D
– 26 May 2027: Class C
– 26 May 2028: Class B and Class A sterile
|IVDD legacy devices may be made available or put into service indefinitely through the safe use of the device, i.e., the “sell-off” provision originally stipulated in IVDR Article 110(4) has been removed|