Legacy devices and MDR - Are you compliant? Analysis of the MDCG 2021-25

Some devices that comply with one of the MD or AIMD directives, and which have not undergone a significant change in design and purpose, may still be marketed after the date of application of the Medical Devices Regulation (MDR), until 26 May 2024 at the latest (end of the transitional period).

These are the following devices:

• "legacy devices", which are devices with a valid CE certification issued under one of the DM or AIMD directives before 26 May 2021 and Class I devices declared by the manufacturer before 26 May 2021, which have been placed on the market after 26 May 2021

• "old devices" placed on the market before 26 May 2021 in accordance with one of the directives

The Medical Device Coordination Group (MDCG) published on 21 October 2021 the MDCG 2021-25 document on the application of MDR requirements to those devices remaining on the market. This is an opportunity to remove further grey areas for economic operators and Notified Bodies (NBs).

Main requirements for legacy devices according to Article 120 (3) of the MDR 

• Application to legacy devices of the new requirements set out in Chapter VII of the MDR relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and devices, and other related requirements of the MDR (including the system for recording and reporting safety incidents and corrective actions, the obligation to cooperate with authorities etc.)

• Implementation of appropriate monitoring of legacy devices by NBs in accordance with the monitoring activities applicable under one of the directives (not the MDR), while taking into account that new requirements apply to manufacturers as a result of the transitional period

• Requirement in particular of post-market surveillance report for class I devices (Art. 85 MDR) and periodic safety update report (PSUR) for all other devices (Art. 86 MDR). Small clarification in this regard on classification: a possible change in the risk class of these devices under the MDR should not be taken into account during the transition period, except for active implantable devices subject to IVDD now considered as class III devices

• NBs' verification that the manufacturer has implemented the necessary adjustments in accordance with the new MDR requirements on the post-marketing surveillance plan(PMS) and vigilance (further guidance to be developed on this by the NBO WB)

• Drawing up and updating PSURs and making this documentation available to (i) competent authorities on request and (ii) NBs as part of surveillance audits (outside EUDAMED)

• The need for existing contracts between the NB and the manufacturer to cover all monitoring activities to be carried out by the NB during the transition period, without the need for amendment or additional costs due to the addition of PSURs to the documentation

• After certification in accordance with the MDR, further updating and communication of PSURs to the NB involved in the conformity assessment procedure defined in Article 52 of the MDR and examination by the NB in accordance with Article 86 of the MDR

As a consequence, compliance of legacy devices with the MDR means compliance with one of the above-mentioned directives and the additional requirements according to Article 120 (3) of the MDR.

The requirements of the MDR outside the scope of PMS, market surveillance, vigilance, and registration of economic operators and devices, such as the implant card (Art. 18), the IUD system (Art. 27) or the summary of safety and clinical performance characteristics (Art. 32), are therefore not applicable to these devices. Somewhat surprisingly, the PRRC requirement (Art. 15) is also excluded.

The MDCG recalls that economic operators will always have the possibility to follow the requirements of the MDR, in particular if they deal with both legacy devices and MDR devices.

In any case, systems and procedure packs combining legacy devices and MDR devices are subject to Article 22 of the MDR, as opposed to those including only legacy devices (Art. 12 MD Directive), which are subject to the transitional provisions of Article 120 (3) of the MDR.

MDR requirements for "old devices"

• Applicability of Articles 93 to 100 of the MDR, which set out the rights and obligations of competent authorities in relation to market surveillance activities

• Clarification of practical details of market surveillance activities for these devices to be undertaken in the framework of the Market Surveillance working group

Registration in EUDAMED

Finally, it should be recalled that all devices placed on the market after 26 May 2021 (legacy device or not) are declared in EUDAMED.

As we have seen, legacy devices are not subject to UDI obligations, but they will be assigned a specific unique identifier in the "MD/UDI" module.

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