Quick Answer: If your device still carries a CE mark issued under the old MDD or AIMDD directives, rather than under the current MDR, the extended transition to 31 December 2027 or 31 December 2028 is not automatic just because those dates exist. Under Regulation (EU) 2023/607, qualifying required two separate deadlines, not one: a formal application lodged with a notified body by 26 May 2024, and a signed written agreement with that notified body by 26 September 2024 [1]. Your quality management system also had to meet MDR Article 10(9) by 26 May 2024 [1]. All three dates have already passed. If you met them, the extension applies automatically by law, but it isn't permanent regardless: withdrawing your application, losing your agreement without transferring to a new notified body, or making a significant change to your device's design or intended purpose during the extension all end it, even now, years later [1]. Which final deadline applies, 2027 or 2028, depends on your device's classification under current MDR rules, which can differ from the class shown on your existing MDD certificate [1].
Two deadlines, not one, and most guides blur them together
This is the single most common imprecision in coverage of this topic, and it matters because the two dates require different things.
26 May 2024 was the deadline to lodge a formal application for conformity assessment with a notified body, and separately, the deadline for your quality management system to meet MDR Article 10(9) [1]. The application had to identify your device and manufacturer clearly enough for the notified body to verify classification and the applicable conformity assessment route, but it did not need to include full technical documentation for every device at that stage [1].
26 September 2024 was the deadline for the written agreement itself to be signed between you and the notified body [1]. The European Commission's own guidance is explicit that these are separate steps: lodging an application is not the same as having a concluded agreement, and only the signed agreement satisfies the legal condition [1].
If your organization completed the application but the agreement wasn't actually signed until after September 2024, that's worth checking directly with your notified body rather than assuming the earlier date carried you through.
The extension isn't a one-time gate. It's an ongoing condition.
This is the part that gets the least attention in general coverage, and it's the part with real, present-tense exposure for a manufacturer today, not just a historical compliance question.
What can undo your qualification, even now
The European Commission's guidance states plainly: if a manufacturer withdraws its application for conformity assessment, or if the written agreement is terminated, the conditions are no longer met and the transitional period ceases to apply [1]. That's true regardless of how long ago the original deadlines were satisfied.
There's a legitimate escape valve built into this. If you need to move to a different notified body, because your original body has capacity constraints or for any other reason, the extension continues to apply as long as you simultaneously sign a new written agreement with the incoming notified body, and the arrangement follows the transfer principles in Article 58 MDR [1]. What doesn't preserve the extension: switching notified bodies specifically because your original body refused your application or declined to issue a certificate over non-compliance [1]. In that case, the transitional period does not continue.
A third, easier way to lose it applies throughout the entire transition period, not just at its start: a significant change to your device's design or intended purpose during the extension invalidates the legacy status, per MDCG 2020-3 guidance on significant changes under Article 120 [1]. The Commission's own Q&A is explicit that this bar sits above routine administrative changes, such as a manufacturer's name, address, or legal form, which generally don't count [1]. But a genuine design change or a shift in intended purpose does, and it's easy to make one over a three- or four-year extension window without connecting it back to this specific consequence.
Which deadline applies to your device: 2027 or 2028
The split between the two final deadlines follows MDR Annex VIII classification rules, applied as they stand today, not the classification shown on your existing MDD or AIMDD certificate [1]. In most cases the two align, but where MDR's own classification rules produce a different risk class than the directive did, the current classification governs which deadline applies, while the MDD-based class continues to determine which MDR requirements apply during the transitional period itself (for example, PSUR obligations) [1].
| Deadline | Applies to | Notable exceptions |
|---|---|---|
| 26 May 2026 | Class III custom-made implantable devices only | No further extension available; this deadline has already passed |
| 31 December 2027 | Class III devices; Class IIb implantable devices | Sutures, staples, dental fillings, dental braces, tooth crowns, and certain screws, wedges, plates, wires, pins, clips, and connectors fall under 2028 instead |
| 31 December 2028 | Class IIa, other Class IIb, Class I sterile or with a measuring function, and Class I devices requiring notified body involvement under MDR | — |
Best for: confirming which deadline your device falls under before assuming your MDD-stated class settles the question.
Custom-made Class III implantable devices: a deadline that already passed
These devices could be placed on the market without an MDR certificate only until 26 May 2026, and only if the application was lodged by 26 May 2024 and the written agreement signed by 26 September 2024 [1]. No further extension exists for this category. If that describes your device and you're reading this after May 2026, that specific pathway has already closed.
Even if you qualify, the notified body bottleneck is still real
Qualifying for the extended deadline buys you time against the calendar. It doesn't buy you a notified body with capacity to actually complete your assessment before that deadline arrives. Notified body review currently runs 13 to 18 months on average once an application is accepted, and busy bodies are separately running intake queues of 6 to 12 months before formal review even starts. A manufacturer with a December 2027 deadline who hasn't already progressed meaningfully through review has less runway than the calendar alone suggests.
If you're also weighing whether to prioritize this MDR work against a first FDA submission, that sequencing decision has its own logic worth working through separately, since the two processes don't share a timeline and rarely benefit from being deprioritized against each other by default.
What to actually check right now
- Confirm both 2024 dates were met, precisely. Application lodged by 26 May 2024, written agreement signed by 26 September 2024. Check your actual paperwork, not your recollection.
- Confirm your application and agreement are still active. No withdrawal, no termination without an active transfer to a new notified body.
- Reconfirm your device's classification under current MDR Annex VIII rules, not your MDD certificate's stated class, to know whether you're on the 2027 or 2028 track.
- Check your notified body's current capacity and realistic timeline for your device, and treat any gap between that timeline and your deadline as an active risk, not a future problem.
- If you're mid-transition to a new notified body, confirm the new written agreement is signed, not just discussed, since an unsigned transfer doesn't preserve the extension.
Common mistakes
Treating "we applied in 2024" as sufficient. The application and the signed agreement were separate deadlines four months apart. Only the signed agreement satisfies the legal condition.
Assuming your MDD certificate's device class determines your MDR deadline. It's current MDR Annex VIII classification that decides between 2027 and 2028, and the two can differ.
Assuming the extension is permanent once granted. Withdrawing an application, losing an agreement without transferring it, or making a significant design or intended-purpose change during the extension all end it, even long after 2024.
Confusing custom-made Class III implantable devices with the general Class III timeline. This category had its own earlier deadline, 26 May 2026, which has already passed with no further extension.
Underestimating notified body capacity as the real constraint. Qualifying for 2027 or 2028 doesn't guarantee a notified body can complete your assessment before then.
Frequently asked questions
Is my CE mark still valid if it was issued under the old MDD? It can be, but only if specific conditions were met by 2024, not automatically because your device is lower-risk or your certificate predates MDR. A CE mark issued under MDD or AIMDD remains valid through the extended transition only if you lodged a formal application with a notified body by 26 May 2024, signed a written agreement by 26 September 2024, and had an MDR-compliant quality system in place by the same May 2024 date. If any of those didn't happen, or if your application was later withdrawn, your CE mark's legacy validity may not extend as far as the 2027 or 2028 dates suggest.
What is the deadline for the MDD to MDR transition? It depends on device classification under current MDR rules: 31 December 2027 for Class III devices and Class IIb implantable devices (with some exceptions moved to 2028), and 31 December 2028 for most other legacy devices requiring notified body involvement. Custom-made Class III implantable devices had a separate, earlier deadline of 26 May 2026, which has already passed.
Do I automatically qualify for the extended MDR transition deadline? No. Qualification required a formal application lodged with a notified body by 26 May 2024, a signed written agreement with that notified body by 26 September 2024, and an MDR-compliant quality management system in place by 26 May 2024. All three conditions had to be met; none of them is automatic based on your device's class alone.
Can I lose my extended transition period after 2024? Yes, in three ways. Withdrawing your application for conformity assessment, having your written agreement terminated without transferring to a new notified body under an active agreement, or making a significant change to your device's design or intended purpose during the extension all end it immediately, regardless of how long ago you originally qualified. Routine administrative changes, such as your company's name or legal form, generally don't count.
Can I make design changes to my device during the extended transition period? Only within limits. Per MDCG 2020-3 guidance, a significant change to the device's design or intended purpose invalidates the extension, while administrative changes to the manufacturer's details generally don't. If you're planning a meaningful design update, checking it against this guidance before implementing it is worth doing deliberately, not assuming your existing legacy status simply carries forward.
Does my MDD certificate's device class determine my MDR deadline? Not necessarily. The 2027-versus-2028 split follows current MDR Annex VIII classification rules, which can produce a different risk class than the MDD did for the same device. Reconfirming classification under current rules, rather than relying on your existing certificate, is worth doing directly.
What happens if my notified body can't complete my assessment before my deadline? The extended transitional period doesn't extend further to accommodate notified body capacity constraints. If you need to change notified bodies, doing so with a simultaneous signed agreement with the incoming body preserves the extension; delaying that switch, or losing your agreement without a replacement in place, does not.
Is the sell-off deadline still a concern? No. Regulation (EU) 2023/607 removed the sell-off deadline entirely. Devices bearing a CE mark placed on the market during the applicable transitional period may continue to be made available afterward without a time limit, subject to the device's own shelf life.
Does IVDR have the same transition deadlines as MDR? No, and the dates are commonly misstated. IVDR transitional periods were extended separately, under Regulation (EU) 2024/1860, to 26 May 2025 for Class D devices, 26 May 2026 for Class C devices, and 26 May 2027 for Class B devices and sterile Class A devices, subject to their own qualifying conditions under Article 110(3c) IVDR. These are earlier and structured differently from the MDR dates covered here, so don't assume your IVD's deadline mirrors a comparable MDR device's.
What's the biggest risk for a manufacturer who met the 2024 deadlines? Assuming the extension is now permanent and unconditional. It remains contingent on an active, unwithdrawn application and agreement, and on your notified body actually having the capacity to complete your assessment before your specific deadline arrives.
Key takeaways
The 2024 qualifying conditions were two dates, not one. Application by 26 May 2024; signed written agreement by 26 September 2024. Confirm both were actually met, on paper.
The extension is conditional on an ongoing basis, not a one-time gate. Withdrawal, an unreplaced terminated agreement, or a significant design or intended-purpose change all end it, even years after 2024.
Your deadline depends on current classification, not your old MDD certificate. The two can differ under MDR's own Annex VIII rules.
Custom-made Class III implantable devices already hit their deadline. 26 May 2026 has passed, with no further extension for that category.
Qualifying for the deadline and actually meeting it are different problems. Notified body capacity remains the real constraint regardless of which calendar date applies to you.
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If your MDR transition status genuinely isn't clear, or if you're weighing that timeline against a US market entry, that's worth mapping out precisely before either deadline gets closer. Complizen's free Gap Assessment reviews your specific device and regulatory history in writing, including a recommended sequencing plan. Request your Gap Assessment →
References
- European Commission — Q&A on Practical Aspects Related to the Implementation of Regulation (EU) 2023/607, Rev. 2 (July 2024). https://health.ec.europa.eu/document/download/592008f6-3456-4afb-a13a-733a87da1b00_en?filename=mdr_proposal_extension-q-n-a.pdf
- EUR-Lex — Regulation (EU) 2023/607 of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices. https://eur-lex.europa.eu/eli/reg/2023/607/oj
- EUR-Lex — Regulation (EU) 2017/745 on medical devices (MDR). https://eur-lex.europa.eu/eli/reg/2017/745/oj
- European Commission — Regulation (EU) 2024/1860 amending transitional provisions for certain in vitro diagnostic medical devices (IVDR extension). https://eur-lex.europa.eu/eli/reg/2024/1860/oj