Legacy Device PMS Obligations Under MDR

Legacy status changes your certification timeline, not your safety obligations

A common misread of the MDR transition provisions is that devices still certified under MDD — so-called legacy or Article 120 devices — have some kind of reduced regulatory status while they wait for MDR certification. They don't. The sell-off provisions and extended transition dates set out in Article 120 (as amended by Regulation 2023/607) apply to whether a device can remain on the market. They say nothing about reducing a manufacturer's PMS, vigilance, or safety obligations in the meantime.

This distinction matters enormously in practice. A manufacturer running a device under an MDD certificate that has been extended to 2028 under Article 120 must run a full MDR-aligned PMS system for that device from now — not from the date of MDR certification. The competent authorities do not treat legacy device status as a grace period for PMS. Inspections have confirmed this. If you have legacy devices on the market, their PMS obligations are current and MDR-aligned, full stop.

What MDR requires from Article 120 devices — right now

For any device on the market under an MDD certificate, regardless of its Article 120 transition status, MDR requires:

Active PMS. You must have a PMS plan for the device that meets the substance of MDR Article 84 requirements. This means defined data sources, defined thresholds, defined review frequencies, and a documented link between PMS outputs and your technical documentation updates. A PMS plan written for MDD — which was far less prescriptive — is not sufficient.

PSUR or PMSR. The periodic reporting obligation under MDR applies based on device class. Class IIa and IIb devices require a periodic safety update report (PSUR), and Class III devices require annual PSUR. Class I devices produce a post-market surveillance report (PMSR). These obligations apply from the date MDR applies to your device in practice — and since Article 120 devices are still on the market, these reports are due.

Vigilance reporting. The MDR vigilance reporting rules — Article 87 and the implementing regulation — apply to serious incidents involving any device on the EU market, regardless of whether the device is certified under MDD or MDR. If one of your MDD-certified legacy devices is involved in a serious incident today, the MDR reporting timeline and format apply.

PMCF. For most device classes, post-market clinical follow-up is not waived for legacy devices. If you do not have a current PMCF plan for your Article 120 devices, this is a gap that will surface when you seek MDR certification — and increasingly, it surfaces in NCA inspections before that.

Where MDD compliance still applies — and the tension it creates

An MDD-certified device must continue to meet the essential requirements under MDD for as long as it is certified under that directive. If you make a significant design change to a legacy device, it may need to be assessed under MDR rather than MDD — which is one of the factors that can force early transition out of Article 120.

The tension this creates for PMS is real: you are running MDR-aligned PMS obligations on a device that is still formally certified under MDD. If your PMS data reveals a significant safety finding that warrants a design change, you need to think carefully about whether implementing that change triggers a change in certification status. This is exactly the kind of question where the interaction between your PMS system and your design change management procedure matters. Getting it wrong can accelerate your MDR transition timeline unexpectedly — or leave a safety issue unaddressed because of certification concerns.

Common gaps for legacy device portfolios

The most frequent gap seen in legacy device PMS is the absence of a compliant PSUR or PMSR. Manufacturers with large MDD portfolios sometimes assume that as long as the device is still certified under MDD, the MDD periodic review requirements apply — which typically meant less frequent and less structured reporting. Under MDR, the PSUR/PMSR obligation applies regardless.

A second gap is PMCF. Legacy devices often have clinical data from their MDD certification — sometimes from the 1990s or early 2000s — that was sufficient then and is not sufficient now. Building a PMCF plan for a legacy device is not just a preparation step for MDR certification. It is a current obligation. Notified Bodies reviewing MDR dossiers for legacy devices frequently ask for the PMCF plan covering the transition period.

A third gap involves EUDAMED registration. Article 120 devices are expected to be registered in EUDAMED as the system becomes operational. If your legacy devices are not in EUDAMED, this affects your UDI assignment and your ability to submit electronic vigilance reports — which creates a downstream problem for PMS operations.

Planning the transition without creating a PMS gap

The practical risk for many manufacturers with large legacy portfolios is that PMS infrastructure built for MDR certification applies to new or recently certified devices, while legacy devices still run on MDD-era procedures. This creates an unintentional two-tier system where legacy devices receive lower-quality PMS attention.

A straightforward mitigation: for any legacy device you intend to keep on the market past its current MDD certificate expiry, build a transition PMS plan now that brings it to MDR standard on data sources, thresholds, review frequency, and PSUR/PMSR reporting. Treat the transition date as the deadline for having a compliant MDR dossier, and treat today as the date you need to start collecting the PMS data that will feed into that dossier.

If you have legacy devices you do not intend to maintain through MDR transition — devices you plan to withdraw from the market — you still need to maintain vigilance reporting and complaint handling until they are no longer on the EU market. Withdrawal from the market does not immediately terminate your PMS obligations for devices already in use.

Where to go from here

The PSUR versus PMSR classification resource in this category covers the reporting structure and frequency requirements for different device classes under MDR. The PMS plan structure resource covers what a compliant MDR PMS plan must contain. If you are managing the broader MDR transition, the EU MDR overview and conformity assessment routes resources in the MDR fundamentals category provide context on the transition framework.