EU / Medical Devices — MDR Transition
MDD to MDR transition timeline: every deadline from 2021 to 2028
The transition from the old Medical Device Directives to the MDR is a sequence of seven dates, not one cut-off. Two of them — 26th May 2024 and 26th September 2024 — were conditions a manufacturer had to meet to reach the others. The remaining end dates are 26th May 2026, 31st December 2027 and 31st December 2028, and which one applies depends on the device's class.
Last updated 12th September 2026 · By Vas Parshin and Anabel Amar
The MDD to MDR transition timeline
- 25th May 2017 — the MDR enters into force. The transitional provisions cover certificates issued by notified bodies under Directives 90/385/EEC and 93/42/EEC from this date that were still valid on 26th May 2021 and have not been withdrawn since.
- 26th May 2021 — the MDR applies. The date of application was postponed by one year from 26th May 2020 by Regulation (EU) 2020/561. The two Directives are repealed with effect from this date, and continue to apply only to the extent needed for the transitional provisions themselves.
- 26th May 2024 — condition, not an end date. Originally the end of the transitional period. It is now the date by which the manufacturer had to have a quality management system in place under Article 10(9) and have lodged a formal application with a notified body under Annex VII, Section 4.3.
- 26th September 2024 — second condition. The notified body and the manufacturer had to have signed the written agreement under Annex VII, Section 4.3, second subparagraph.
- 26th May 2026 — class III custom-made implantable devices. These could be placed on the market without a notified body certificate only until this date, and only if both 2024 milestones were met. Already passed.
- 31st December 2027 — all class III devices, and class IIb implantables. The class IIb implantable group excludes sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors, which fall in the 2028 group instead.
- 31st December 2028 — everything else. The remaining class IIb devices, class IIa devices, and class I devices placed on the market in sterile condition or having a measuring function. The same date applies to class I devices whose conformity assessment needed no notified body under the MDD, whose declaration of conformity was drawn up before 26th May 2021, and which now require notified body involvement under the MDR.
Class IIb implantable is split across both dates
This is the part most timelines get wrong. "Implantable class IIb goes in 2027" is not quite the rule. Article 120(3a)(a) names an explicit list of class IIb implantables that are carved out of the 2027 group — sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors — and those sit with the 2028 cohort under point (b). A portfolio of orthopaedic fixation hardware and a portfolio of active implants are on different clocks even though both are class IIb implantable.
The extension was never automatic
Article 120(3c) sets five conditions, and all of them have to hold. The device must continue to comply with the Directive it was certified under. There must be no significant change in its design or intended purpose. It must not present an unacceptable risk to health or safety. The quality management system had to be in place by 26th May 2024, with the formal notified body application lodged by the same date. And the written agreement with the notified body had to be signed by 26th September 2024. A manufacturer that missed either 2024 milestone cannot rely on the extended dates at all, whatever the device class.
These dates stop placing on the market, not selling through
Article 120(4) is a separate provision and it is easy to miss. Devices lawfully placed on the market before the applicable date may continue to be made available on the market or put into service afterwards. So 31st December 2027 is the last date a covered device can be placed on the market; units already in the distribution chain on that date are not withdrawn by the deadline itself.
Not the same deadline as EUDAMED
The MDR transition timeline is separate from EUDAMED registration (27th November 2026), which covers database entry, not certificate validity. A device can be correctly registered in EUDAMED and still lose its basis to be placed on the EU market on 31st December 2027 if the underlying certificate has lapsed. Both deadlines apply independently to the same legacy-device population.
Questions
What is the MDD to MDR transition timeline?
Seven dates, set by Article 120 of Regulation (EU) 2017/745 as amended by Regulation (EU) 2023/607. 25th May 2017: the MDR enters into force. 26th May 2021: the MDR applies and the two Directives are repealed, except as needed for the transitional provisions. 26th May 2024: quality management system in place under Article 10(9) and formal application lodged with a notified body. 26th September 2024: written agreement signed with the notified body. 26th May 2026: last date for class III custom-made implantable devices without a notified body certificate. 31st December 2027: all class III devices and class IIb implantables other than the carved-out list. 31st December 2028: remaining class IIb, class IIa, class I sterile or measuring, and up-classified class I.
What are the EU MDR legacy device transition deadlines?
Two end dates for certificated legacy devices. All class III devices, and class IIb implantable devices other than sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors, may be placed on the market until 31st December 2027. The remaining class IIb devices, class IIa devices, and class I devices placed on the market in sterile condition or having a measuring function follow on 31st December 2028, as do class I devices whose MDD conformity assessment needed no notified body but whose MDR assessment does. A separate date of 26th May 2026, now passed, applied to class III custom-made implantable devices.
How is this different from the EUDAMED registration deadline?
EUDAMED (27th November 2026) is a database registration requirement — actor, device, UDI and certificate data must be entered into the EU's database. This deadline is about certificate validity itself: whether the underlying MDD/AIMDD certificate a legacy device relies on still legally permits it on the market at all. A device can in principle be EUDAMED-registered and still fall off the market on 31st December 2027 if its certificate lapses.
Does every legacy device automatically get the extended timeline?
No. Article 120(3c) sets five conditions: the device must still comply with Directive 90/385/EEC or 93/42/EEC; there must be no significant change in its design or intended purpose; it must not present an unacceptable risk to health or safety; the manufacturer must have put a quality management system in place under Article 10(9) no later than 26th May 2024 and lodged a formal application with a notified body by the same date; and the notified body and manufacturer must have signed a written agreement no later than 26th September 2024. A manufacturer that missed either 2024 milestone cannot rely on the extended dates.
What happens on 31st December 2027 to a device that misses it?
The old MDD/AIMDD certificate stops supporting placing the device on the market. Without a transitioned MDR certificate by that date, a class III or implantable class IIb device loses its legal basis to be placed on the EU market. Article 120(4) is separate: devices already lawfully placed on the market before the date may continue to be made available or put into service, so existing stock in the distribution chain is not what the deadline stops.
Where we fit
Placing each legacy SKU on the right line of this timeline is a portfolio-wide audit, not a single form — which devices met both 2024 milestones, which class IIb implantables fall in the 2027 group rather than 2028, and which up-classified class I devices now need a notified body at all. We scope the legacy-device gap across your product range, coordinate with your notified body on transition timing, and manage the certification programme end to end.
Contact usSources
- Article 120 of Regulation (EU) 2017/745 as amended by Regulation (EU) 2023/607 — paragraphs 3a(a) and 3a(b) for the 2027 and 2028 dates, 3b for up-classified class I, 3c for the conditions, 3f for class III custom-made implantables. Official Journal text read directly, 12th September 2026