EU MDR Transition Deadlines and the Conditions That Closed

Almost everyone selling medical devices in Europe knows the EU MDR transition deadlines: 31 December 2027 and 31 December 2028. Far fewer know that the extension granting those dates was conditional, and that two of the conditions had deadlines in 2024 which have already passed.

If one of those was missed for a device, the extension never applied to it. That is not a documentation gap to close later — it means the device has been placed on the market without a lawful basis, and it is checkable from your own records.

How the extension came about

The original Article 120 of the EU MDR gave legacy devices until 26 May 2024, with a sell-off deadline a year later. By 2022 it was clear that notified body capacity could not absorb the portfolio in time.

Regulation (EU) 2023/607 of 15 March 2023 rewrote the provision. It extended the dates by class, removed the sell-off deadline entirely, and — the part that gets less attention — attached five conditions.

The deadlines

Note what the deadline governs: placing on the market or putting into service. Devices lawfully placed before the deadline are not made unlawful by it. Overstating this is a real commercial cost — it has led manufacturers to write off saleable stock they were entitled to keep supplying.

One derogation has already expired: Article 120(3f) permitted class III custom-made implantable devices without a notified body certificate only until 26 May 2026.

The five conditions

Article 120(3c) makes the extension conditional. All five must hold.

Conditions (d) and (e) are historical facts now. They either happened or they did not, and there is no mechanism to remedy them retrospectively.

So the first thing to establish for each legacy device is not a plan but an evidence position: which document proves the quality management system was in place by 26 May 2024, which record proves the application was lodged by 26 May 2024, and which signed agreement carries a date on or before 26 September 2024. “Yes” without a document reference is the answer that fails.

Where a condition cannot be evidenced, escalate the same day. The options are to complete MDR conformity assessment before placing further devices on the market, or to stop. Continuing to supply while the file is reconstructed is not one of them.

Condition (b) is the one that bites during the transition

“No significant changes in design and intended purpose” applies continuously, and it produces an asymmetry that catches engineering teams by surprise: for a legacy device, an improvement can end its right to be on the market.

A design change that would be routine on an MDR-certified device may, on a legacy one, mean the device must complete MDR conformity assessment before the next unit ships. That is a programme, not a change note.

Where the change is necessary for safety, it is not optional. If it is also significant, the honest options are to certify or to withdraw. Characterising a safety-necessary change as insignificant in order to preserve a transition is the sort of decision that reads badly in hindsight, and the change record is where it will be read.

Assess it deliberately, and record the commercial consequence alongside the technical one — the volume and revenue exposed, the certification status, and the decision taken with its approval.

Article 120(3d): the obligations that already apply

The single most-missed provision in the transition. Article 120(3d) applies the Regulation’s requirements on post-market surveillance, market surveillance, vigilance, and registration of economic operators and devices to legacy devices now, in place of the corresponding Directive requirements.

In practice that means a manufacturer still supplying under a Directive certificate must already be running, for those devices:

• an Article 83 post-market surveillance system and an Article 84 plan;
• an Article 85 PMS report or an Article 86 PSUR, on the cycle its class requires;
• Article 87 vigilance with the 2-day, 10-day and 15-day reporting clocks;
• Article 88 trend reporting with a defined methodology and observation period;
• Article 89 field safety corrective action handling;
• Article 29 device registration and Article 31 economic operator registration in EUDAMED.

A manufacturer running MDR post-market processes only for MDR-certified devices therefore has a gap across its whole legacy portfolio. It is common, it is material, and it is one of the easiest things for a competent authority to check.

Planning the certification, honestly

Two numbers decide whether a device makes its deadline, and only one of them is under your control.

The first is the size of your evidence gap — typically the clinical evaluation, which under MDR is a materially higher bar than it was under the Directives, and the technical documentation restructured to Annex II.

The second is notified body lead time, which has been the binding constraint throughout this transition. Record the lead time your body has actually quoted and the date it quoted it. A figure given eighteen months ago is not a planning input, and treating it as one is how a programme discovers in Q3 2028 that it needed to start in Q1 2027.

Every device on the plan should carry a contingency: what happens if certification slips past the deadline. Usually the answer is to stop placing on the market and supply from certified stock — which is legitimate precisely because the sell-off deadline was removed.

Not every legacy device should be certified

Certification costs are real and some devices will not repay them. Deciding to discontinue is a legitimate outcome, and it is better made deliberately in 2026 than by default in 2028.

One thing to build into that decision rather than discover after it: Article 10a, inserted by Regulation (EU) 2024/1860. Where a manufacturer anticipates an interruption or discontinuation of supply and it is reasonably foreseeable that this could result in serious harm or a risk of serious harm to patients or public health, it must inform the competent authority and the operators, health institutions and healthcare professionals it directly supplies — normally at least six months in advance.

The trigger is anticipation, not the event. A decision not to certify a device is a decision to discontinue supply on a known date, so the Article 10a assessment belongs inside that decision.

A revision is proposed, but do not plan on it

On 16 December 2025 the Commission adopted COM(2025) 1023, proposing amendments to Regulations (EU) 2017/745 and 2017/746 to simplify and reduce burden. It is a proposal in the ordinary legislative procedure — not law.

Record its status and re-check it on a schedule. But a transition plan that assumes a further extension is a plan with no contingency, and this transition has already taught the industry what that costs.

What to do this quarter

1. List every device still supplied under a Directive certificate.
2. For each, produce the document references proving conditions (d) and (e) — not a Yes.
3. Escalate any device where you cannot.
4. Confirm the Article 120(3d) obligations are actually running for those devices, including EUDAMED registration.
5. Refresh the notified body lead time and date it.
6. Decide, per device, whether to certify, discontinue or transfer — and run the Article 10a assessment on anything you will discontinue.

Our EU MDR Toolkit includes a legacy device transition plan, a significant change assessment procedure, a supply interruption notification procedure and a transition deadline and condition tracker that takes evidence references rather than Yes/No against each of the five conditions — alongside 64 further templates covering Regulation (EU) 2017/745 as consolidated on 19 July 2026.

Frequently asked questions

What are the EU MDR transition deadlines?

31 December 2027 for class III devices and class IIb implantables other than a listed set of well-established technologies, and 31 December 2028 for other class IIb, class IIa and class I devices placed on the market sterile or with a measuring function. Up-classified class I devices also run to 31 December 2028.

Was there a sell-off deadline?

There was, and Regulation (EU) 2023/607 removed it. Devices lawfully placed on the market before the applicable deadline may continue to be made available and put into service afterwards.

What happens if we missed the 26 May 2024 application deadline?

The Article 120(3c) conditions are cumulative, so the extension does not apply to that device. It cannot lawfully be placed on the market under Article 120, and the position should be escalated immediately rather than managed quietly.

Does a design change end the transition?

A significant change in design or intended purpose does. Condition (b) of Article 120(3c) applies continuously, so any proposed change to a legacy device should be assessed against it before implementation.

Do MDR post-market rules apply to legacy devices?

Yes. Article 120(3d) applies the Regulation’s post-market surveillance, market surveillance, vigilance and registration requirements to legacy devices now, in place of the Directive equivalents.

Will the deadlines be extended again?

There is a Commission proposal, COM(2025) 1023 of 16 December 2025, to simplify the framework, but it is a proposal and not law. Planning on the basis of an extension that has not been adopted leaves a programme with no contingency.