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.

The following are legacy devices:

• Devices that had a valid MDD/AIMDD CE Marking certificate on 26 May 2021, that did not expire before 20 March 2023, and were not withdrawn by the Notified Body.

• Devices that had a valid MDD/AIMDD CE Marking certificate on 26 May 2021 but expired prior to 20 March 2023, if the following conditions are met: 1) it was not withdrawn by the Notified Body; and 2) before the CE certificate expired the manufacturer either had a signed written agreement in place with the Notified Body or had been granted an Article 59(1) derogation or Article 97(1) authorization by an EU Competent Authority.

• Devices that were Class I self-certified under the MDD, but were up-classed under the MDR, and held a Declaration of Conformity lawfully drawn up prior to 26 May 2021.

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 must continue to comply with the MDD/AIMDD

• No significant changes to the design or intended purpose of the device after 26 May 2021

• The device must 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

• Manufacturer must comply with the MDR’s market surveillance, post-market surveillance, vigilance, and registration requirements

• No later than 26 May 2024, implement an MDR-compliant quality management system (in accordance with MDR Article 10(9))

• No later than 26 May 2024, have lodged an application with a Notified Body for conformity assessment for that device (in accordance with Section 4.3, first subparagraph, of Annex VII)

• Manufacturer must have a written agreement in place with a Notified Body no later than 26 September 2024

The device is still eligible for the full legacy device extension, if the following criteria have been met:

• The CE Certificate was valid on 26 May 2021, and

• The CE Certificate was not withdrawn afterward, and

• Before the CE Certificate expired, the manufacturer had a signed written agreement in place with a Notified Body (per Section 4.3, second subparagraph, of Annex VII), and/or

• A Competent Authority had granted a derogation in accordance with Article 59(1) or authorization under Article 97(1)

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.

• Manufacturers can generate a self-declaration statement, confirming that the extension requirements per Regulation 2023/607 have been fulfilled. The statement should clearly identify the devices covered by the extension and the CE Certificate(s) to which it applies.

• The Notified Body could issue a confirmation letter stating the “receipt of the manufacturer’s application for conformity assessment and the conclusion of a written agreement”. Like the above self-declaration, the Notified Body’s confirmation should clearly identify the devices covered by the extension and applicable CE Certificates.

• Manufacturers (or their authorized representatives) could request Certificates of Free Sale and the Competent Authority could issue them noting the extended CE marking validity period.

Per MDCG 2020-3 manufacturers may make the following changes without impacting its legacy device status:

• Administrative changes, such as to the manufacturer’s name or address or to the authorized representative, are considered administrative changes.

• Changes that do not have an impact on the device’s design or intended purpose. For example, change in manufacturing site, including changes that affect subcontractors and suppliers.

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:

• Changed ingredient or material from an existing supplier, that meets the existing specifications

• Shelf-life change validated by protocols approved by the Notified Body

Examples of changes to the intended purpose/design that do constitute a significant change include:

• New user or patient population

• New or modified architecture or database structure, change of an algorithm for software devices

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:

• Market surveillance

• Post-market surveillance, including obligations to generate Periodic Safety Update Reports (PSURs)

• Vigilance reporting requirements

• Economic Operator & Device registration requirements

• No later than 26 May 2024, the quality system requirements in accordance with MDR Article 10(9)

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.

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.