The Article 120 extension runs on three clocks

A legacy device still certified under the old Medical Device Directive doesn't run out on one date — a transition tracker built around a single “MDR deadline” field is already simplifying something MDR Article 120 deliberately didn't leave simple. Regulation (EU) 2023/607, which entered into force in March 2023, rewrote Article 120's transitional scheme into three separate deadlines keyed to device risk class, and attached each one to conditions most manufacturers had to satisfy on their own, now-passed 2024 clocks. A file that tracks the extension without tracking which class it's reading, and whether those upstream conditions were actually met, is trusting an extension it hasn't confirmed the device still qualifies for.

Three dates, sorted by class

Article 120, as amended, splits legacy devices into three deadline groups rather than one. Custom-made implantable Class III devices carried the shortest runway: their transitional window closed on 26 May 2026, a date that has already passed. Other Class III devices and implantable Class IIb devices — with a named list of exceptions covering sutures, staples, dental fillings, braces, crowns, and similar well-established fixation and dental hardware, which get the longer date instead — run to 31 December 2027. Everything else the extension reaches — the excepted implantable Class IIb devices, other Class IIb devices, Class IIa devices, Class I devices placed on the market sterile, and Class I devices with a measuring function — runs to 31 December 2028. A device's risk classification isn't just an upstream determination that stops mattering once it's made; under Article 120, it's the input that decides which of three transition clocks the device is actually running against.

The extension isn't automatic — it was earned in 2024

None of the three dates apply to a device by default. Article 120 conditions the extension on the device holding a valid certificate issued under the old directives, on the device undergoing no significant change in its design or intended purpose since that certificate issued, and on the device continuing to present no unacceptable risk to health or safety. Layered on top of those substantive conditions is a procedural one with its own deadline that has already closed: the manufacturer had to lodge a formal application with a notified body for MDR conformity assessment by 26 May 2024, and follow it with a signed written agreement with that notified body by 26 September 2024. A manufacturer that missed either 2024 date lost the extension for that device regardless of what class it falls into — the three class-based dates only apply to a device that already cleared this earlier gate.

“No significant change” is the condition most likely to erode quietly

Of the substantive conditions, the no-significant-change requirement is the one a transition file can lose track of without anyone deciding to change anything. A labeling update, a supplier substitution, or a manufacturing process change made for reasons that have nothing to do with MDR compliance can still cross into “significant” territory under the interpretive guidance MDCG has issued on the question, and a change log that tracks these updates against internal design-control triggers without also asking the Article 120 question has left a live compliance risk unmonitored. A design change record built for ISO 13485's own change-control clause doesn't automatically ask MDR's transitional-eligibility question on its own; a legacy-device file needs that check added deliberately, not assumed.

Extension doesn't mean the MDR obligations already in force pause

A device running out the transitional clock under Article 120 doesn't stop owing the MDR obligations that took effect independent of full certification — post-market surveillance, vigilance reporting, and the registration and UDI duties that apply regardless of which certificate underlies the device. A post-market surveillance plan built for a fully MDR-certified device doesn't get to run a lighter version for a device still on legacy paperwork; the extension buys time on certification, not on the surveillance duties that already apply to any device on the EU market.

Where this meets the rest of the file

A legacy-device transition tracker built around all three class-based deadlines, the substantive and procedural conditions Article 120 actually attaches to each, and the standing MDR obligations that keep running regardless of certificate status, is previewed in the launch catalog. If your program tracks the Article 120 extension differently, the shelf takes that correction directly.