INTRODUCTION
The EU Medical Device Regulation (EU MDR 2017/745) has completely changed how medical devices are regulated in Europe. It raises the bar on safety, clinical evidence, and post-market surveillance, and it has also introduced a complex, multi-year transition timeline. Initially, manufacturers expected to be done with the MDR transition much earlier. But delays in EUDAMED, limited Notified Body capacity, and concerns about device shortages pushed the European Commission to extend certain deadlines through Regulation (EU) 2023/607 and, later, Regulation (EU) 2024/1860.
KEY EU MDR DEADLINES: WHAT’S ALREADY IN EFFECT
Full application of MDR – from May 26, 2021
- From 26 May 2021, all new devices placed on the EU market must comply with MDR.
- “Legacy devices” with valid CE certificates under the old directives (MDD/AIMDD) can still use the transitional provisions in Article 120 MDR, provided certain conditions are met (QMS upgrade, Notified Body application, and a signed agreement).
Extended transitional periods – Regulation (EU) 2023/607
Full application of MDR – from May 26, 2021
- From 26 May 2021, all new devices placed on the EU market must comply with MDR.
- “Legacy devices” with valid CE certificates under the old directives (MDD/AIMDD) can still use the transitional provisions in Article 120 MDR, provided certain conditions are met (QMS upgrade, Notified Body application, and a signed agreement).
Extended transitional periods – Regulation (EU) 2023/607
To avoid product shortages, the EU adopted Regulation (EU) 2023/607 in March 2023. This amendment extended the MDR transition timelines and removed the earlier “sell-off” deadlines:
- Class III and most implantable Class IIb legacy devices can remain on the market until 31 December 2027, if conditions are met.
- Other Class IIb, Class IIa, Class Is/Im and certain up-classified Class I devices can remain until 31 December 2028, again subject to strict conditions.
- The previous requirement to “sell off” MDD/AIMDD stock by a fixed deadline has been removed.
WHAT’S COMING NEXT : MDR DATES AND MAJOR DEADLINES (2024–2028)
The timeline below outlines key MDR obligations, distinguishing between those already in effect and those that are upcoming.
Already passed but still important
26 May 2024 – QMS and Notified Body application (legacy devices)
To benefit from the extended transition:
- Manufacturers had to implement a QMS in line with MDR Article 10(9) by 26 May 2024.
- For legacy devices, a formal application for MDR certification had to be lodged with a Notified Body by the same date.
26 September 2024 – Written agreement with the Notified Body
- By 26 September 2024, the MDR requires a signed written agreement between manufacturer and Notified Body for legacy devices to continue benefiting from the transitional timelines.
Manufacturers who missed these two milestones generally cannot rely on the extended MDR transition and may need to seek derogations at national level or withdraw affected devices.
2025 – New duty to inform on supply interruptions
10 January 2025 – New supply-disruption notification obligation
Regulation (EU) 2024/1860 introduces a new “duty to inform” if a manufacturer plans to interrupt or discontinue the supply of certain medical devices or IVDs. From 10 January 2025, manufacturers must:
- Notify authorities and, in many cases, customers in advance if a disruption or discontinuation may lead to patient-care issues.
- Have internal processes in place to detect and escalate potential supply risks early.
2025–2027 – EUDAMED becomes progressively mandatory
Regulation (EU) 2024/1860 also changes how EUDAMED goes live. Instead of waiting until all modules are ready, the database will become mandatory module by module.
In practice, this means:
- From 2025–2026:
Mandatory use begins in phases for Actor registration, UDI/device registration, and Certificates/Notified Body data modules after each is formally declared fully functional in the Official Journal. - By around early 2027:
All core EUDAMED modules, including vigilance, are expected to be in mandatory use, with the transition period for device registration ending by roughly Q3 2026.
Exact trigger dates will depend on EU notices, so manufacturers must actively monitor Commission communications.
2026 – Custom-made Class III devices
- 26 May 2026 is the final deadline for custom-made Class III devices to fully comply with MDR. They cannot rely on the longer 2027/2028 transitional dates.
2027 – End of transition for high-risk legacy devices
- 31 December 2027:
All legacy Class III and most implantable Class IIb devices must be MDR-certified to remain on the EU market. After this date, MDD/AIMDD certificates for these categories are no longer valid.
2028 – Final MDR transition deadline
- 31 December 2028:
Remaining legacy Class IIb (non-implantable), Class IIa, Class Is, Class Im, and some up-classified Class I devices must hold MDR certification.
After this date, all legacy certificates expire and all devices on the market must be MDR-compliant.
WHAT REGULATION (EU) 2024/1860 CHANGED
Regulation (EU) 2024/1860, in force since 9 July 2024, amended both the MDR and IVDR. For medical devices, the key impacts are:
- Gradual EUDAMED roll-out
Mandatory use of EUDAMED is now linked to each module’s readiness, instead of “all modules at once.” - Obligation to inform about supply interruptions
A new Article 10a introduces a duty for manufacturers to inform authorities and, where relevant, other actors in the supply chain about interruptions or discontinuations that could harm continuity of care. - Extended transitional provisions for some IVDs
For IVD manufacturers, 2024/1860 extends certain IVDR transition periods. While that is outside the MDR focus here, it is important for companies that have both devices and IVDs.
CONCLUSION
The MDR transition has moved from “something in the future” to an active compliance and business-continuity challenge. With the 2027 and 2028 deadlines now clearly framed and new obligations such as supply-interruption notifications and EUDAMED data requirements manufacturers cannot afford to treat MDR as a one-time project. Instead, it needs to be integrated into everyday operations, from design and clinical strategy to supply chain and data management.
How Morulaa Can Help
Morulaa supports medical device manufacturers in navigating EU MDR compliance with tailored regulatory strategies, technical documentation support, and Notified Body coordination. We also help prepare for EUDAMED requirements and manage end-to-end compliance to ensure timely market access without disruptions.