Legacy Device Transition Under EU MDR: What Changed and Where Things Stand

What the transition was supposed to look like

When EU MDR (Regulation 2017/745) became applicable in May 2021, it came with a built-in grace period for devices that already held a valid MDD or AIMDD certificate. Article 120 allowed those devices to continue being placed on the market until their existing certificates expired — with a hard outer limit that was originally set at May 2024. The assumption was that manufacturers would use the intervening years to transition their technical documentation, update their clinical evaluations, and get their Notified Body audits done.

That did not happen at the scale the Commission expected. The Notified Body system was severely bottlenecked. Many manufacturers, particularly smaller ones, found themselves months into transition work with no realistic path to a completed MDR certification before the 2024 deadline. The risk of a large number of devices disappearing from the European market — including devices with no clear substitute — became a serious policy concern.

What changed: the Article 120 amendments

Regulation 2023/607, which amended Article 120 of MDR, was the legislative response. It extended the transition period significantly for most device classes and introduced a set of conditions that manufacturers have to meet to benefit from the extension. The key change is that the deadline is no longer a single date — it now depends on the class of your device and, crucially, on whether you had a written agreement with a Notified Body in place before a specific cutoff date.

This is the part that catches a lot of teams off guard: the extended deadlines are not automatic. They apply only if you had an active MDD/AIMDD certificate on 5 May 2017 (or a certificate issued after that date under MDD/AIMDD transition rules) and if you had a formal written agreement with a Notified Body — or a submitted application — by 26 May 2024. If your device falls outside those conditions, the old deadlines may still apply to you.

Two dates you need to keep separate: placing on the market vs. sell-off

This is where a lot of manufacturers get confused, and getting it wrong is costly in both directions.

Placing on the market means the first time a device is made available in the EU supply chain — typically when you ship from your warehouse to a distributor or directly to a customer. There is a hard deadline for when you can no longer do this for a legacy device. Once your transition deadline passes (and you do not yet have MDR certification), you cannot place new stock on the market. It does not matter that the device is safe, that it has an MDD certificate, or that it is mid-certification with your Notified Body. New shipments into the supply chain stop.

Making available / sell-off is a separate action that happens further down the chain — a distributor selling from existing stock, or a hospital drawing from inventory already in the building. Regulation 2023/607 introduced an explicit sell-off window that runs beyond the placing-on-the-market deadline. For Class IIb and Class III devices, that sell-off window runs to 31 December 2028. For Class IIa and lower-risk devices, it runs to 31 December 2027. During this window, existing inventory in the supply chain can still be sold and put into service — but no new stock can be added to that chain.

In plain terms: the transition deadline is the last date you can ship. The sell-off date is the last date your distributors and customers can sell or use what you already shipped. These are different actions, governed by different deadlines, and your supply chain and regulatory teams need to track them separately. If your company is managing wind-down inventory for a device that will not reach MDR certification, the sell-off date is the number to plan against for customer commitments and distributor contracts.

Why this matters in practice

The transition timeline is now a multi-variable problem. Where your device sits depends on its class, your certificate status, your Notified Body agreement date, and whether you are still placing the device on the market or only managing existing stock. Many manufacturers are running more than one scenario in parallel — some products are fully MDR-certified, others are in active Notified Body review, and a few may be managed as wind-down inventory. Getting the timeline wrong in any of these lanes has real consequences: either premature market withdrawal, or continuing to place devices you are no longer entitled to.

The sections in this category cover each of these variables in detail — the class-by-class deadlines, what the Notified Body agreement requirement actually means, clinical evaluation gaps, and how to structure transition work across a portfolio.