Medical devices: where MDR, IVDR and Eudamed stand

Where things stand, in one line

Regulation (EU) 2017/745 on medical devices (MDR) has applied since 26 May 2021, replacing Directives 93/42/EEC and 90/385/EEC. The changeover is not over, though: Regulation (EU) 2023/607 extended the transitional periods, the last of which runs to 31 December 2028, while since 28 May 2026 the first four modules of the European database Eudamed have been mandatory. Anyone with a device on the European market today is living under two regimes at once.

MDR deadlines, by class

Regulation (EU) 2023/607 rewrote Article 120 of the MDR. For devices covered by a certificate issued under the old directives and valid on 20 March 2023, the deadlines for placing on the market are staggered by risk class:

• Class III custom-made implantable devices — 26 May 2026, a deadline that has already passed.
• Class III and class IIb implantable devices — 31 December 2027.
• Class IIb non-implantable, class IIa, class I sterile or with a measuring function — 31 December 2028.
• Class I devices that needed no notified body under the directives, with a declaration of conformity issued before 26 May 2021, and that now require one under the MDR — 31 December 2028.

The extension was never automatic

This is where most of the wishful thinking happened. Those dates only apply if the manufacturer met two formal steps, both now in the past: an application for MDR certification lodged with a notified body by 26 May 2024 and a written agreement signed with that body by 26 September 2024. Substantive conditions apply as well: the device must still comply with the original directive, must not have undergone significant changes in design or intended purpose, must pose no unacceptable risk, and the manufacturer must have a quality management system in place. A manufacturer who missed one of those steps is not in transition — it is out.

Eudamed is no longer optional

By Decision (EU) 2025/2371, published on 27 November 2025, the Commission declared the first four Eudamed modules — actors, UDI and devices, notified bodies and certificates, market surveillance — fully functional, starting the six-month clock set by Article 123 of the MDR. Since 28 May 2026 their use has been mandatory. The first practical step is registering as an economic operator and obtaining the SRN, without which devices cannot be registered. The remaining modules, among them clinical investigations and vigilance, will follow on their own timetable.

In vitro diagnostics follow a different calendar

Regulation (EU) 2017/746 (IVDR) received a later and wider extension under Regulation (EU) 2024/1860. For devices that needed no notified body under the old directive, with a declaration of conformity before 26 May 2022, the dates for placing on the market are 31 December 2027 for class D, 31 December 2028 for class C and 31 December 2029 for class B and sterile class A. Intermediate deadlines apply here too for the application and the agreement with the notified body, and the same regulation introduced a duty to give at least six months' notice where interrupting the supply of a device could cause serious harm to patients.

What this means for a manufacturer

The work concentrates on three fronts. First, classification: the risk class determines the assessment procedure and therefore whether a notified body is needed at all. Second, the technical documentation of Annexes II and III, which the MDR made more demanding than the old directive, above all on clinical evaluation and the benefit-risk ratio. Third, post-market surveillance: the plan, the periodic safety update report, the clinical follow-up. This is where manufacturers used to the directives find the sharpest discontinuity, because it calls for a process many of them did not, in practice, have.

Who does what

Certifying medical devices is for notified bodies designated under the MDR: no consultant can issue that certificate or pre-empt its outcome. The work that can be done upstream is different and just as decisive: checking the classification, building the technical documentation, aligning the quality management system, preparing the company for assessment. At LDL the same separation applies as on management systems: whoever helps a manufacturer prepare is not whoever then assesses its conformity.

Official sources

• Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices — EUR-Lex
• Regulation (EU) 2017/746 on in vitro diagnostic medical devices — EUR-Lex
• Regulation (EU) 2023/607, amending the transitional provisions of the MDR and the IVDR
• Regulation (EU) 2024/1860, on the gradual roll-out of Eudamed and IVD transitional periods
• Commission Decision (EU) 2025/2371 of 27 November 2025 on the full functionality of the first Eudamed modules
• European Commission, medical devices and Eudamed — health.ec.europa.eu
• Italian Ministry of Health, medical devices section — salute.gov.it

The dates above were verified on the publication date of this piece. The subject has been amended several times in a few years and a targeted revision of the regulations is under discussion at European level: before making decisions, always check the consolidated text on EUR-Lex and the Commission's notices. For an assessment of your own case, get in touch.