EU MDR Compliance Timeline (2024 to 2028): What Manufacturers Must Know Now

The EU Medical Device Regulation (EU MDR 2017/745) has revolutionized the way medical devices are regulated in the EU. This regulation has set high standards for safety, clinical data, and post market supervision but has also brought about a highly intricate timeline spanning several years. In the beginning, the industry expected to complete the transition process much sooner. However, due to delays with the EUDAMED system, scarcity of Notified Bodies, and fears of device shortages, the European Commission decided to extend some deadlines via Regulation (EU) 2023/607 and later on via Regulation (EU) 2024/1860.

Key EU MDR Deadlines: What’s Already In Effect

Full implementation of MDR - from May 26, 2021

• As of 26 May 2021, all new medical devices being introduced to the European market should conform to the MDR.

• Devices labeled as "legacy" and possessing valid CE certificates under previous legislation (MDD/AIMDD) will still be able to enjoy the transition period provided by Article 120 MDR.

Extended transitional periods – Regulation (EU) 2023/607

In order to prevent any shortages of products, the EU has implemented Regulation (EU) 2023/607 in March 2023. This regulation revised the transition timelines for MDR and eliminated the previous sell off requirements:

• Class III and most of Class IIb implantable legacy devices are allowed to stay in the market till 31 December 2027, under specified conditions.

• Class IIb, Class IIa, Class Is/Im, and some up classified Class I products are allowed to stay in the market till 31 December 2028, provided strict conditions are fulfilled.

• The previous deadline to sell off the MDD/AIMDD stock is no longer required.

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 relevant

26 May 2024 - QMS and Notified Body application (legacy devices)

• To make use of the extended transition period:

• Manufacturers were required to establish an MDR compliant QMS in accordance with Article 10(9) of the MDR by 26 May 2024.

• As regards legacy devices, manufacturers were required to lodge an application for MDR certification with a Notified Body on the same date.

26 September 2024 - Written Agreement with Notified Body

By 26 September 2024, the MDR stipulated a written agreement between the manufacturer and the Notified Body for legacy medical devices in order to benefit from the transitional periods provided by the MDR.

If manufacturers fail to meet both deadlines, they will most likely be unable to benefit from the MDR transition period and have to apply for derogations at the national level.

New duty to inform on supply disruptions (2025)

10 January 2025 – New duty to inform on supply disruptions

• The Regulation (EU) 2024/1860 establishes a new duty to inform where a manufacturer intends to disrupt or discontinue the supply of a particular type of medical device or IVD. As from 10 January 2025, the manufacturer should:

• Inform authorities and in many instances patients when there is an anticipated disruption that could impact patient care.

• Be able to identify any possible disruption to their supply internally.

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:

Between 2025-2026:

• The use of Actor registration, UDI/device registration, and certificates/notified body modules becomes mandatory in stages once they are officially deemed to be fully operational in the Official Journal.

Early in 2027:

• It is expected that all key EUDAMED modules, including vigilance, will be in use on a mandatory basis with the transition period for device registration ending by around Q3 2026.

Trigger dates will be determined by official EU notifications, so manufacturers should stay informed of Commission communications.

2026    Custom made Class III devices

• The latest deadline in which all custom made Class III devices will fully conform to the MDR is 26 May 2026, as they can’t be dependent on the later dates 2027/2028.

• 2027     Transition period ends for high risk legacy devices

December 31, 2027:

• All legacy Class III and most implantable Class IIb devices have to obtain MDR certificates in order to stay on the EU market after that date. The MDD/AIMDD certificates will not be accepted.

2028  Final MDR Transition Deadline

31 December 2028:

• Class IIb (non implantable), Class IIa, Class Is, Class Im, and some reclassified Class I devices will need to be MDR certified.

• After this date, all legacy certifications become obsolete, and all the devices on the market have to meet the MDR requirements.

What Regulation (EU) 2024/1860 Changed

Regulation (EU) 2024/1860, effective from 9 July 2024, has also revised the MDR and IVDR. The important consequences in regard to medical devices are as follows:

Introduction Of Eudamed In Steps

Use of EUDAMED becomes mandatory, depending on the availability of each module separately, not “all modules altogether.”

Notification Of Disruption To The Supply Of Goods

Article 10a establishes a new requirement that manufacturers shall inform the competent authority about disruptions to the supply of goods which may impact continuity of treatment.

IVDS Further Transition Periods Until 2024

As far as IVDs are concerned, 2024/1860 provides more time for transition periods in accordance with the IVDR. This is outside the scope of the MDR but is pertinent for those companies producing both sets of products.

Conclusion

MDR migration has shifted from “something in the future” to an ongoing problem of compliance and continuity of business. Considering that the 2027 and 2028 deadlines have been well established and that there are also additional responsibilities like notification of supply disruption and EUDAMED data, MDR cannot be treated just as a project but should become a part of routine business.

How Morulaa Can Help

At Morulaa, we assist medical device manufacturers in complying with EU MDR through customized regulatory strategies, documentation assistance, and coordination with Notified Bodies. We also facilitate our clients’ preparation for EUDAMED and compliance management throughout the process to guarantee uninterrupted market access.