Between 2024 and 2029, four major European regulatory frameworks reach maturity simultaneously for medical device manufacturers: MDR 2017/745, IVDR 2017/746, the AI Regulation 2024/1689 and EUDAMED. None of these deadlines can be treated in isolation. They overlap, they influence one another, and a delay on one compromises the others.
This consolidated timeline gathers the enforceable dates, the conditions to be met and the real notified body review times. It is built from the consolidated EUR-Lex texts and the MDCG guidances in force as of 1 July 2026.
MDR deadlines: Article 120 as amended by Regulation 2023/607
The transitional regime of Regulation (EU) 2023/607 of 15 March 2023 overhauled Article 120 of the MDR. Two paragraphs now structure the deadlines.
Article 120(3bis)(a): 31 December 2027. This deadline covers all class III devices and class IIb implantable devices. The text explicitly excludes certain categories of implantables: sutures, staples, dental fillings, orthodontic appliances, dental crowns, screws, wedges, plates, guide wires, pins, clips and connectors.
Article 120(3bis)(b): 31 December 2028. This deadline covers non-implantable class IIb devices (and the implantables excluded from point a), class IIa devices, and class I devices placed on the market in sterile condition or with a measuring function.
Article 120(3ter): also 31 December 2028. It concerns devices for which Directive 93/42/EEC did not require the involvement of a notified body, but for which the MDR conformity assessment procedure now does. These are typically former class I devices that move up in class under the MDR classification rules.
The distinction between implantable IIb and non-implantable IIb is critical. A manufacturer of a non-implantable class IIb device that plans on the basis of 31 December 2027 instead of 31 December 2028 wastes resources. The reverse is more dangerous: a manufacturer of a IIb implantable that plans around 2028 loses a year it does not have.
The four cumulative conditions (Article 120, 3quater)
None of these extensions applies automatically. Article 120(3quater) imposes four cumulative conditions that the manufacturer must continuously satisfy:
The device must remain compliant with the directive under which it falls (90/385/EEC or 93/42/EEC). No significant change may be made to its design or intended purpose. The device must not present an unacceptable risk to the health or safety of patients, users or other persons. And the manufacturer must have taken active steps with an MDR notified body, evidenced by a written agreement with a notified body designated under the MDR.
If any one of these four conditions ceases to be met, the device loses the benefit of the transitional regime. It can no longer be placed on the market.
What the real notified body timelines imply
Published timelines are not operational timelines. For class IIa, notified bodies report review times of 9 to 18 months between file submission and certificate issuance. For classes IIb and III, these times extend from 12 to 24 months, with strong variability depending on the notified body’s workload, the quality of the file and the complexity of the device.
A class III device manufacturer submitting its file in early 2026 is cutting its timeline fine for certification before the end of 2027. A class IIb implantable manufacturer in the same situation has no margin at all. The useful submission window for classes III and IIb implantable is already open, and it is closing progressively.
For classes IIa and IIb non-implantable (2028 deadline), the window is wider but notified body congestion keeps growing. Manufacturers waiting until 2027 to submit expose themselves to the same saturation problem.
The MDR obligations already in force, even under the transitional regime
Article 120(3) of the MDR recalls that the transitional regime does not suspend the entire regulation. Since 26 May 2021, the following obligations apply to all devices, including those benefiting from the transitional provisions: post-market surveillance (PMS), market surveillance, vigilance, and registration of economic operators and devices.
A manufacturer benefiting from the transitional period but which has not implemented a PMS system compliant with the MDR requirements has been in breach for more than five years.
IVDR deadlines: Article 110 as amended by Regulation 2024/1860
Regulation (EU) 2024/1860 of 13 June 2024 significantly extended the IVDR transitional periods for legacy devices. The timeline is staggered by IVDR risk class, with three milestones per class: deadline to lodge the application with a notified body, deadline to sign a written agreement, and end date for placing on the market under the transitional regime.
Class D (highest risk: blood grouping tests, HIV, hepatitis, transmissible agents). Application to a notified body before 26 May 2025. Written agreement signed before 26 September 2025. Placing on the market allowed until 31 December 2027.
Class C (influenza tests, certain tumour markers, self-testing devices). Application to a notified body before 26 May 2026. Written agreement before 26 September 2026. Placing on the market until 31 December 2028.
Classes B and sterile A. Application to a notified body before 26 May 2027. Written agreement before 26 September 2027. Placing on the market until 31 December 2029.
For class D IVD manufacturers, the application deadline (May 2025) has already passed. Manufacturers that did not lodge their application in time have lost the benefit of the transitional regime and can no longer place devices on the market under the IVDD regime.
For class C IVD manufacturers, the application deadline was 26 May 2026. It has just passed. Manufacturers that did not submit their application are in the same situation as class D: they lose the benefit of the transition.
Cross-cutting prerequisite: an IVDR-compliant QMS
Regulation 2024/1860 imposes a cross-cutting condition on all classes: a quality management system compliant with the requirements of Article 10(8) of the IVDR had to be in place no later than 26 May 2025. This condition is a prerequisite for any eligibility for the transitional regime. Manufacturers that did not document the compliance of their QMS by that date no longer benefit from the transition periods, whatever the class of their device.
The reality of the IVDR notified body market
The number of notified bodies designated under the IVDR remains structurally insufficient. Under the former IVDD, around 10% of in vitro diagnostic devices required the involvement of a notified body. Under the IVDR, this proportion rises to around 80%. The pressure on notified bodies is of an entirely different nature.
For class D manufacturers, the difficulty is greatest: very few notified bodies cover the class D scope, assessments require the consultation of EU reference laboratories, and review times regularly exceed 18 months. For class C, the situation is less tense but the contract window (September 2026) is fast approaching.
EUDAMED: the first four modules have been mandatory since 28 May 2026
This is the most recent operational change. Commission Decision (EU) 2025/2371, published in the Official Journal on 27 November 2025, confirmed the functional compliance of four EUDAMED modules. In line with Regulation 2024/1860, a six-month period elapsed, making these modules mandatory as of 28 May 2026.
The four modules concerned: actor registration (obtaining the SRN), device registration and the UDI database, notified bodies and certificates, and market surveillance.
Concretely, since 28 May 2026, any economic operator subject to Article 31 MDR or Article 28 IVDR must be registered in EUDAMED and hold an SRN (Single Registration Number) before placing a device on the market. No SRN, no placing on the market. This is no longer a recommendation.
What remains to come on EUDAMED
Two modules are not yet operational: the vigilance and post-market surveillance module, and the clinical investigations and performance studies module. These two modules will be the subject of a separate declaration of functional compliance, with their own six-month period before becoming mandatory.
In the meantime, manufacturers continue to use the existing national channels for vigilance (ANSM in France) and clinical investigation notifications.
For legacy devices already on the market before 28 May 2026, the deadline for registration in the UDI/device module is set at 27 November 2026.
AI Act: Regulation (EU) 2024/1689 and medical devices
The Regulation on artificial intelligence entered into force on 1 August 2024. Its application is progressive, and the date that concerns medical device manufacturers is not the one that most general-purpose summaries highlight.
The obligations for high-risk AI systems listed in Annex III of the AI Act (standalone systems classified by use case) have applied since 2 August 2026.
But medical devices incorporating AI fall under a different provision. They are classified as high-risk by Article 6(1) of the AI Act, in combination with Annex I, because they are already subject to a third-party conformity assessment (the notified body) under the MDR or the IVDR. For these systems, the date of application is 2 August 2027.
This distinction is fundamental. A manufacturer of a class IIb software medical device (SaMD) incorporating an AI component has until 2 August 2027 to comply with the AI Act requirements. This additional year is consistent with the fact that these devices are already subject to a demanding regulatory framework.
What is expected of manufacturers right now
The harmonised standards and delegated acts that will specify how the AI Act applies to medical devices are being drafted. Several elements are already usable: the AI Act requirements on data governance, technical documentation, human oversight and risk management largely overlap with what the MDR already requires via Annex I (GSPR), ISO 14971 and IEC 62304.
Manufacturers of medical devices incorporating AI have every interest in anticipating the integration of the AI Act requirements into their technical documentation and risk management system. Waiting for the publication of each delegated act to begin means reproducing the delay scenario the industry experienced with the MDR.
What must be done, by manufacturer profile
MDR manufacturer under the transitional regime, classes III and IIb implantable. The useful submission window is closing. If the file is not already under review by a notified body, every month lost compresses the margin before the 31 December 2027 deadline. The conditions of Article 120(3quater) must be documented and traceable at all times.
MDR manufacturer under the transitional regime, classes IIa and IIb non-implantable. The 31 December 2028 deadline offers more calendar margin, but notified bodies are increasingly loaded. Submitting before the end of 2026 remains the realistic recommendation to avoid the 2027 bottleneck.
IVDR class D manufacturer. The application date has passed (May 2025). If the application was lodged in time and the agreement signed before September 2025, the manufacturer benefits from the transitional regime until 31 December 2027. The others must obtain full IVDR certification to keep their devices on the market.
IVDR class C manufacturer. The application date has just passed (26 May 2026). Manufacturers that submitted in time must imperatively sign an agreement with their notified body before 26 September 2026. That is in less than three months.
Manufacturer of a medical device incorporating AI. The AI Act deadline is 2 August 2027. The gap assessment between existing documentation (risk management, performance evaluation, technical documentation) and the AI Act requirements must begin now, without waiting for the final delegated acts.
Any economic operator. EUDAMED is no longer optional. Check actor registration, obtain the SRN, and plan the UDI registration of devices already on the market before 27 November 2026.
Regulatory sources
- Regulation (EU) 2017/745 (MDR), consolidated version: EUR-Lex
- Regulation (EU) 2023/607 amending the MDR and IVDR transitional provisions: EUR-Lex
- Regulation (EU) 2024/1860 amending the IVDR transitional provisions: EUR-Lex
- Regulation (EU) 2024/1689 (AI Act): EUR-Lex
- Decision (EU) 2025/2371 on EUDAMED functional compliance: EUR-Lex
- European Commission, EUDAMED: health.ec.europa.eu
- European Commission, IVDR transitional provisions: health.ec.europa.eu