If you want to be one step ahead of the MDR due dates for the coming year, check out these important MDR dates and deadlines for 2026.
Please note: The MDR is no stranger to adjusted schedules. So keep in mind the dates and deadlines presented in this post may change.
2026 MDR dates and deadlines you need to know
1 May 2026
Mandatory use of MIR form v 7.3.1 begins
What’s happening? From 1st of May 2026 onwards, it will be required to use version 7.3.1 of the Manufacturer Incident Report (MIR) form for reporting serious incidents to competent authorities (source).
Who’s impacted? It is the manufacturers’ responsibility to inform competent authorities of serious incidents.
Probability it’ll happen? Looks certain. The final version has been published on the European Commission’s website (see the link above).
26 May 2026
End of MDR transition period for class III custom-made implantable devices
What’s happening? 26th of May 2026 marks the end of the extended transition period for class III custom-made implantable devices to comply with the MDR. From that date onwards, those devices must have an MDR certificate issued by a notified body to be placed on the market (source).
Who’s impacted? Manufacturers of class III custom-made implantable devices.
Probability it’ll happen? No legislative changes are in sight to postpone this deadline.
28 May 2026
Mandatory use of EUDAMED four first modules begins
What’s happening? The Commission Decision (EU) 2025/2371 in 26 November 2025 confirmed that the first four modules of EUDAMED have achieved functionality and meet the functional specifications (source). This was published in the OJEU in 27 November 2025. It started a six-month transition period. So as of 28th of May 2026, the use of Actor registration, UDI/Devices registration, Notified Bodies & Certificates, and Market Surveillance modules will be required.
Who’s impacted? The Actor registration affects manufacturers, system and procedure pack producers, authorised representatives and importers. UDI/Devices registration concerns manufacturers and system and procedure pack producers. Notified Bodies & Certificates module requires action from the notified bodies. Market Surveillance module is mainly for competent authorities. All these stakeholders need to make sure their data and processes are ready to comply by 28th of May 2026.
It’s also worth mentioning that the mandatory use of the four modules will bring value to a lot of people. I’m talking about the general public, patients, healthcare professionals, authorities, manufacturers, distributors, importers and many others. For example, they can track devices better, respond to safety issues faster and check the status of a device before making it available.
Probability it’ll happen? EUDAMED has struggled with many delays over the years. However, the publication in the OJEU has anchored the binding use of the first four modules.
Q2 2026
Testing the implementation of the Breakthrough Devices (BtX) guidance
What’s happening? In December 2025, Medical Device Coordination Group (MDCG) published MDCG 2025-9 Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746. It is intended to provide guidance for manufacturers, expert panels and notified bodies on the process and regulatory considerations relevant for qualifying, assessing and certifying breakthrough medical devices and breakthrough IVDs. With the guidance, MDCG included a note saying a pilot to roll-out the guidance is expected to be launched in Q2 2026 (source).
Who’s impacted? Manufacturers of devices meeting the breakthrough devices’ criteria provided in the MDCG 2025-9. The MDCG 2025-9 mentions pilot in connection with scientific advice to non-Art.61(2) BtMD and BtIVD. Therefore, especially those manufacturers requesting scientific advice from the expert panels should pay attention to the pilot schedule.
Probability it’ll happen? Likely to happen, but the schedule looks quite tentative. No specific target dates have been set. I believe we can expect reschedulings, possibly due to the legislative procedure of the medical devices regulations’ targeted revision in 2026, which includes debating the addition of BtX rules to the MDR.
9 November 2026
Assignment of Master UDI-DI to contact lenses becomes mandatory
What’s happening? The transition period of assigning Master UDI-DI to contact lenses was extended with Commission Delegated Regulation (EU) 2025/788 by one year (source). This means that the deadline was postponed from 9 November 2025 to 9 November 2026.
Who’s impacted? Manufacturers of contact lenses have the responsibility to comply with all the UDI requirements. This includes assigning the Master UDI-DI to contact lenses.
Probability it’ll happen? An extra year will likely be sufficient for manufacturers to adapt to the Master UDI-DI implementation. The new guidance MDCG 2024-14 Rev. 1 Guidance on the implementation of the Master UDI-DI solution for contact lenses and MDCG 2025-7 Rev. 1 MDCG Position Paper: Timelines of the implementation of ‘Master UDI-DI’ to contact lenses and spectacle frames, spectacle lenses and ready-to-wear reading spectacles published in 2025 support the Master UDI-DI application according to the deadline.
Hopefully, this checklist of MDR dates and deadlines for 2026 makes it easier for you to remember these due dates.
If you have any questions about them – whether they apply to you, or what you need to do by a certain deadline – feel free to send me a message.
I’m always happy to listen to what’s on your mind and help you take the next step.
Happy New Year 2026 to you!
