Transition Timeline
The MDR is postponed by one year.
The EU Commission announces EUDAMED will be delayed.
Released for voluntary use. The EUDAMED Actor Registration Module is not expected to be mandatory until Q4 2024.
The UK is no longer recognized as part of the EU.
Manufacturers in Great Britain (England, Scotland, Wales) require an EU Authorized Representative to continue marketing in the EU, and EU manufacturers must appoint a UK Responsible Person and register their devices with the UK MHRA.
The MHRA provides a one-year transition period to register devices, exact dates depend on the device classification. The EU does not provide a transition period.
AIMD, Class III, Class IIb implantable devices and Annex II, List A IVDs must be registered by this date.
The UK Responsible Person (UKRP) must complete the registration, if the manufacturer is established outside of the UK.
All devices new to the market must be CE Marked to the MDR.
All devices that are Class I self-certified under both MDD and MDR, must be CE Marked to the MDR as of today to continue being placed onto the market.
MDD Class I self-certified devices which were up-classed under the MDR and Class I sterile/measuring, IIa, IIb and III devices with valid MDD/AIMDD Notified Body issued CE Marking may continue marketing through the transition periods outlined in MDR Article 120(3). Certain conditions apply – click here for more information.
On the MDR’s date of application, the Swiss-EU Mutual Recognition Agreement (MRA) for medical devices lapsed. Due to larger political reasons, the MRA does not include a provision for the Medical Device Regulation (MDR). Therefore, Switzerland becomes a ‘third country’ to Europe as it relates to medical devices.
Swiss manufacturers require an EU Authorized Representative (AR) to market in the EU and all non-Swiss manufacturers require a Swiss Authorized Representative to market in Switzerland. Swissmedic provides a transition period to appoint the CH-REP. The EU does not provide a transition period.
Swissmedic has implemented the MDR into its legislation, other than the country-specific, such as the appointment of a Swiss AR instead of an EU AR.
Due to the lapsed Mutual Recognition Agreement (MRA) with Europe, Switzerland is a ‘third country’ related to medical devices. Swissmedic, therefore, instituted its own importer requirements.
A transition period is implemented for importers to identify themselves with MDD/AIMDD legacy devices. However, no such transition period is granted for MDR CE Marked devices and Swiss importers must identify themselves immediately. The importer may be identified on the device, the packaging, or in a document accompanying the device.
UDI carrier required on MDR Class III and implantable device labeling. Not applicable to MDD/AIMDD legacy devices.
Class IIb Non-implantable, Class IIa medical devices and Annex II, List B and Self-test IVDs must be registered by this date.
The UK Responsible Person (UKRP) must complete the registration, if the manufacturer is established outside of the UK.
Released for voluntary use. The EUDAMED Device/UDI & Notified Body (NB)/Certificates Registration Modules are not expected to be mandatory until Q2 2026.
The IVDR is not delayed outright (like the MDR was). Instead, the EU institutes a longer transition period for most IVDD legacy devices; exact dates depend on the device classification.
Class III/AIMD and Class IIb implantable device manufacturers must have a Swiss Authorized Representative (AR) appointed in order to continue marketing in Switzerland.
MDR: the Swiss AR (“CH-REP”) must be identified on the device label or in a document accompanying the device until 31 July 2023. Starting 1 August 2023, the CH-REP must be identified on the label.
MDR devices already on the Swiss market before 26 May 2022 have until 31 December 2021 to appoint and identify the CH-REP. MDR devices newly placed onto the market after 26 May 2022 must immediately identify the CH-REP.
MDD already marketed in Switzerland before 26 May 2021: the Swiss AR (“CH-REP”) must be identified on the device label, the instructions for use, or in a document accompanying the device. The deadline to appoint and identify the CH-REP is by 31 December 2021.
MDD newly marketed in Switzerland after 26 May 2021: the Swiss AR (“CH-REP”) must be identified on the device label or the instructions for use. The deadline is as soon as the manufacturer begins marking the device in Switzerland.
AIMDD already marketed in Switzerland before 26 May 2021: the Swiss AR (“CH-REP”) must be identified on the sales packaging and in the instructions for use, or in a document accompanying the device. The deadline to appoint and identify the CH-REP is by 31 December 2021.
AIMDD newly marketed in Switzerland after 26 May 2021: the Swiss AR (“CH-REP”) must be identified on the sales packaging and in the instructions for use. The deadline is as soon as the manufacturer begins marking the device in Switzerland.
Class I medical devices, General IVDs and Custom-made Devices must be registered by this date.
The UK Responsible Person (UKRP) must complete the registration, if the manufacturer is established outside of the UK.
When is the new MDR compliance deadline for legacy devices?
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
*CMDs are not technically legacy devices under MDR Article 120. However, they have been granted a further extension under EU Regulation 2023/607.
Which devices qualify as a ‘legacy’ device under the transition extension?
The following are legacy devices:
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.
What is the criteria to remain a legacy device, i.e., avoid having to MDR CE Mark early?
In order to remain a legacy device, the following criteria must be met:
What if my MDD/AIMDD CE Certificate expired before May 20, 2023?
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.
How do I prove my device is a valid legacy device under the extension?
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.
What kinds of changes can I make to the device without impacting its legacy device status?
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.
Which parts of the MDR apply to my legacy device(s)?
The following aspects of the MDR apply to MDD/AIMDD CE Marked legacy devices:
What if I don’t plan to CE Mark under the MDR? Am I still eligible for the extension?
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.
The reason is that by 26 May 2024, manufacturers should have 1) implemented an MDR-compliant quality management system and 2) lodged an application with a Notified Body to MDR CE Mark that device. If the manufacturer is not intending to MDR CE Mark, and therefore has not completed these actions, then the device ceases to be recognized as a legacy device.
Will Switzerland and the UK recognize the MDR transition extension?
Yes, both Swissmedic and the UK MHRA released announcements that they will recognize the MDR transition period extension granted under EU Regulation 2023/607.
Switzerland
Swissmedic’s announcement that it will recognize the MDR extension in Switzerland is available: HERE
The EU MDR extension is considered immediately effective in Switzerland, despite not aligning with the text in the Medical Device Ordinance (MedDO). Swissmedic advised it will amend its legislation in autumn of 2023, to properly reflect the amendments outlined in EU Regulation 2023/607.
United Kingdom
The MHRA’s announcement that it will recognize the MDR extension in the UK is available: HERE
The UK is made up of the following countries: England, Scotland, Wales (“Great Britain”), and Northern Ireland.
As Northern Ireland requires European CE Marking, the MDR transition extension went into immediate effect upon publication, as it did in the rest of Europe. No further action or statement was required from the MHRA related to this, as Northern Ireland is considered part of the European Single Market.
Great Britain has a separate regulatory system (UKCA Marking). Due to a transitional provision, the MHRA allows CE Marked devices (legacy and MDR/IVDR CE Marked) onto the Great Britain market. The above-linked MHRA announcement states it will also recognize devices covered under the EU MDR extension, e.g., devices with MDD/AIMDD certificates that expired prior to 20 March 2023, but are now considered valid due to EU Regulation 2023/607.
The MHRA advised that it will shortly update its guidance to reflect this change. Further, the MHRA is expected to publish a more formal update to the UK’s transitional provisions by mid-2023.
Before | After |
---|---|
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 |
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 |