Regulation, not directive
The MDD had to be transposed into each member state's national law, which produced variation. MDR applies directly and identically everywhere, so there is no national interpretation to work with or around.
EU MDR (Regulation (EU) 2017/745)
The EU MDR (Regulation (EU) 2017/745) transition, in dates.
EU MDR (Regulation (EU) 2017/745) replaces the Medical Device Directive 93/42/EEC and the Active Implantable Medical Device Directive 90/385/EEC. Applied from 26 May 2021. Legacy devices may remain on the market until 31 December 2027 or 2028 depending on class, but only where the conditions of Regulation (EU) 2023/607 were met — including an application lodged with a Notified Body by 26 May 2024, a date that has passed.
Key timescale
The dates that govern your certificate.
From the Global ACI transition requirements, mandatory for its accreditation body signatories and the certification bodies they accredit. Dates marked as passed are given because they explain where the transition already stands, not because anything remains to be done about them.
- 26 May 2021 passed
EU MDR applied
Regulation (EU) 2017/745 replaced the MDD and AIMDD. Unlike a directive, a regulation applies directly and identically in every member state.
- 26 May 2024 passed
Application cut-off for the extension
To use the extended deadlines, a manufacturer had to have lodged a formal MDR conformity assessment application with a Notified Body by this date. It has passed, so the extension is not something anyone can newly qualify for.
- 26 May 2026 passed
Class III custom-made implantables
The transition deadline for this category, now passed.
- 27 November 2026
EUDAMED registration of legacy devices
A near-term administrative deadline that applies regardless of device class and independently of the transition dates below. Easy to miss because it is not tied to a certificate expiry.
- 31 December 2027
Class III and Class IIb implantable devices
Legacy devices in these classes may not be placed on the market after this date.
- 31 December 2028 deadline
Other Class IIb, Class IIa, Class I sterile or measuring
The final transition date. After it, every device on the EU market must be MDR certified.
What changed
What moved between editions.
The transition document describes the overall impact as minimal. The descriptions below say what moved; the standard’s own text is copyrighted and is not reproduced here.
Reclassification
Many devices moved up a class, and class determines the conformity assessment route, the evidence burden and the timeline. A product that was comfortably Class I under the MDD may be Class IIa now — which changes everything downstream.
Clinical evidence
Equivalence is considerably harder to rely on, particularly where the equivalent device belongs to a competitor and the data is not accessible. Clinical investigation is required for more device types. This is the most common underestimate in an MDR programme.
Post-market as a continuous obligation
Articles 83 to 86 require a PMS plan, a PMS report or Periodic Safety Update Report by class, and post-market clinical follow-up. Under the MDD this was an afterthought; under MDR it is audited.
Scope beyond manufacturers
Authorised Representatives, importers and distributors all carry defined obligations, and an AR can be held liable alongside the manufacturer. Relabellers, repackagers and those assembling procedure packs may become the manufacturer in the eyes of the regulation.
New roles and registrations
A Person Responsible for Regulatory Compliance under Article 15 with defined qualifications, UDI assignment and carriers, and EUDAMED registration of actors, devices and certificates. None of these existed under the MDD.
What to do
A transition is a gap assessment, not a rebuild.
Book the audit early
Certification bodies have to move tens of thousands of certificates inside the same window, and audit capacity is finite. Organizations that wait until the deadline compete for slots with everyone else who waited. Folding the transition into a surveillance or recertification audit you were already having is the cheapest route.
Assess against the changes, not the whole standard
A system that conforms to the previous edition already meets most of EU MDR (Regulation (EU) 2017/745). The work is in the deltas listed above, not in re-reading the standard from clause 4.
Evidence culture, do not assert it
Both quality culture and the newer behavioural requirements are evidenced in what people actually do. An auditor will look for it in practice, not for a policy statement saying the organization has it.
Check what else you hold
Three transitions are running at once, on different clocks. If you hold more than one certificate, the cheapest plan is usually a single combined transition planned against the earliest deadline — which is rarely the one you are thinking of.
Questions
Questions to resolve early.
What is the EU MDR transition deadline?
There are two, by device class. Legacy devices in Class III and Class IIb implantable may remain on the market until 31 December 2027; other Class IIb, Class IIa and Class I sterile or measuring devices until 31 December 2028. Both depend on the conditions of Regulation (EU) 2023/607 having been met.
Can we still qualify for the extended deadlines?
No. The extension required a formal MDR conformity assessment application lodged with a Notified Body by 26 May 2024, alongside continued MDD or AIMDD compliance, no significant change in design or intended purpose, and no unacceptable risk. That application date has passed, so a manufacturer who did not apply in time does not have the extension regardless of what the 2027 and 2028 dates suggest.
What is the 27 November 2026 EUDAMED deadline?
Legacy devices must be registered in EUDAMED by that date. It applies regardless of device class and independently of the transition deadlines, which makes it easy to miss — a manufacturer whose class is not due until 2028 can still be non-compliant in November 2026.
Do MDR obligations apply to our legacy devices before transition?
In part, yes. The extension covers the certificate, not the obligations around it. MDR's post-market surveillance, vigilance and registration requirements already apply to legacy devices placed on the market under the transitional provisions.
How does ISO 13485 fit into the transition?
It is the foundation rather than a substitute. MDR Article 10(9) requires a quality management system without naming a standard; ISO 13485 is harmonised to the regulation, so conformity with it carries a presumption of conformity with those QMS requirements. It covers none of classification, technical documentation, clinical evaluation, post-market surveillance, UDI, EUDAMED, the PRRC or the Authorised Representative.
Other transitions running now
ISO 9001:2026Deadline 30 September 2029ISO 14001:2026Deadline 30 April 2029ISO 37001:2025Deadline 28 February 2027Source: Global Accreditation Cooperation Incorporated, Transition Requirements for EU MDR (Regulation (EU) 2017/745), Regulation (EU) 2017/745 and Regulation (EU) 2023/607. Dates are as that document states them. Other accreditation forums publish equivalent requirements — confirm the position with your own certification body, which is the only party that can commit to your audit dates.
Begin with context
Plan the transition against your audit calendar.
Tell us which certificates you hold, who certifies you and when your next surveillance or recertification audit falls, and we will tell you what the transition actually costs you.