MDCG on appropriate surveillance for legacy devices

On 27 May 2024, the MDCG (Medical Device Coordination Group) published an updated version of MDCG 2022-4. This document is a guidance on appropriate surveillance regarding the transitional provisions for legacy devices in conformity to Article 120 (3e) of the Medical Devices Regulation. In this sense, the surveillance provisions apply to legacy devices covered by a certificate issued in accordance with the MDD or AIMDD. This excludes legacy devices for which the involvement of a notified body was not necessary under the Directives but required under the Regulation.

The surveillance assessment described in MDCG 2022-4 applies to Directives’ notified bodies as long as they have the right to perform surveillance activities – at the latest by 26 September 2024 – and to MDR notified bodies that signed an agreement with a legacy manufacturer.

Notified body surveillance according to the new legacy provisions

From the MDR application date (26 May 2021), legacy devices have to comply with the applicable Directive and with MDR requirements on post-market surveillance, market surveillance, vigilance, and registration of economic operators and devices. Compliance with the applicable MDR requirements is subject to the notified body’s surveillance activities. Notwithstanding, surveillance activities can also cover MDD/AIMDD requirements (see scenarios described below).

Surveillance activities under Article 120 (3e)

No later than 26 September 2024, the MDR notified body is responsible for the appropriate surveillance. Until that date, the Directive’s notified body is responsible for the surveillance activities. This can result in different scenarios:

• The Directive’s notified body is the same as the MDR notified body, the same notified body keeps being responsible for the relevant surveillance activities. In this case, there has to be a contractual agreement addressing all necessary rights and obligations for the appropriate surveillance of legacy devices as well as for all devices, including substitute devices.
• The Directive’s notified body is different from the MDR notified body, there are two options:
  1. The Directive’s notified body, the new MDR notified body, and the manufacturer can sign a contractual agreement specifying that the surveillance activities are transferred to the new MDR notified body even before 26 September 2024. This responsibility is limited to the activities carried out under the appropriate surveillance under Article 120(3e).
  2. The Directive’s notified body is responsible for the surveillance activities until 25 September 2024. This notified body will not be responsible for the surveillance activities performed by the MDR notified body as of 26 September 2024.

Possible scenarios for the appropriate surveillance

The guidance document provides different scenarios of MDR transitions and specifies the applicable provisions and responsibilities regarding surveillance assessment. Depicted scenarios include:

1. Manufacturers of legacy devices that do not benefit from the new extended transitional provisions: notified bodies perform surveillance activities under the Directives and verify implementation of applicable MDR requirements (chapter VII). Notified bodies should also verify that the manufacturer has taken into account the guidelines defined MDCG 2020-3 on significant changes regarding the transitional provision for legacy devices.
2. Manufacturers of legacy devices and MDR devices that have already implemented the MDR requirements in their systems and whose MDR application is already under review: surveillance activities can be performed only according to MDR.
3. Manufacturers of legacy devices and MDR devices already certified by the same notified body for the same and/or partially different devices’ types: the same requirements as under scenario 2 apply.
4. Manufacturers of legacy devices and MDR devices already certified by another MDR notified body: the same requirements as under scenario 2 apply.

All relevant MDR documents are available in our Library of Documents.

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