If you want to stay ahead of the MDR due dates for the coming year, check out these important MDR dates and deadlines for 2025.
Please note: The MDR is no stranger to extended deadlines. So please keep in mind that the dates and deadlines provided could be subject to change.
2025 MDR dates and deadlines you need to know
10 January 2025
Obligation to inform about device supply interruption or discontinuation
What’s happening? The MDR and IVDR amendment through Regulation (EU) 2024/1860 requires manufacturers to inform the relevant competent authority and health institutions before the supply of certain medical devices or IVDs is interrupted or discontinued. This notification obligation applies from 10 January 2025.
Who’s impacted? It is the manufacturers’ responsibility to inform the competent authority and health institutions. To implement the task in practice, manufacturers can request help from their appropriate supply chain partners, such as authorised representatives, importers and distributors. They in turn must help manufacturers to deliver the message.
Probability it’ll happen? There doesn’t seem any doubt whether this obligation is going to be applied from the given date onwards. Just recently MDCG published three guidance documents to support the implementation of this requirement (link).
By end of Q1 2025
Proposal for MDR and IVDR revisions
What’s happening? In October 2024 the European Parliament passed a resolution which calls the European Commission to propose by end of Q1 2025 delegated and implementing acts to the MDR and IVDR to tackle the biggest problems in the MDR and IVDR implementation.
Who’s impacted? The delegated and implementing acts to the MDR and IVDR can affect notified bodies, competent authorities, manufacturers or other economic operators.
Probability it’ll happen? While the resolution puts pressure on the European Commission, there is no guarantee that the Commission will present the requested changes by end of Q1 2025. The Commission is aware of the MDR and IVDR implementation challenges in any case. The Commission has already taken steps to address them. For example, they launched a targeted evaluation of the MDR and IVDR in 2023. The evaluation is expected to be completed in 2025, and I’ll come back to it later in this post.
26 May 2025
Obligation to place UDI carriers on the labels of class I devices
What’s happening? Class I devices are required to comply with the UDI requirements of placing UDI carriers on the device labels on 26 May 2025. This deadline is set in MDR article 123(3)(f).
Who’s impacted? Manufacturers have the obligation to comply with all the UDI requirements. This includes placing the UDI carrier on the label of their devices.
Probability it’ll happen? With no transition period for class I devices under the MDR, there is no escape from this deadline for manufacturers of class I devices.
26 May 2025
Obligation for direct marking of class IIa and class IIb reusable devices
What’s happening? Class IIa and class IIb reusable devices need to have the UDI carrier on the devices themselves by direct marking on 26 May 2025. This deadline is defined in MDR article 123(3)(g)(ii).
Who’s impacted? Only manufacturers may place the UDI on their devices.
Probability it’ll happen? There are three cases where the deadline does not apply: first, the class IIa or class IIb reusable device in question is a legacy device. Second, the direct marking would negatively affect the safety or performance of the device (the direct marking requirement doesn’t apply). Third, if the direct marking would be technologically impractical, then the device in question is exempt from direct marking.
27 May 2025
MDR article 54 evaluation report
What’s happening? According to MDR article 54 (5), the European Commission must by 27 May 2025 create a report on the operation of article 54. The article concerns the clinical evaluation consultation procedure for certain class III and class IIb devices. The Commission is required to send the report to the European Parliament and to the Council, and based on the report, if appropriate, make proposals for amendments to the MDR.
Who’s impacted? Depending on the report by the European Commission, the Commission may make proposals for amendments to the MDR or not. The changes could affect for example manufacturers of class III and class IIb devices.
Probability it’ll happen? No legislative changes are in sight that would prevent or postpone this reporting deadline.
Q2 2025
4 Eudamed modules scheduled to become functional
What’s happening? According to Eudamed roadmap update in 2024, four Eudamed modules are planned to be confirmed functional in Q2 2025. These four modules are said to be: Actor; UDI/Device; Notified Bodies and Certificates; and Market surveillance. The confirmation would mean that the use of these modules becomes mandatory 6 months after the confirmation.
Who’s impacted? After the modules are declared functional by the European Commission, the users of the modules (eg. manufacturers, importers, authorised representatives) need to make sure their data and processes will be ready to comply in six months.
Probability it’ll happen? Eudamed has suffered from so many delays during the years that it’s hard to say whether the deadline will be met or not this time. Hoping for the best – keeping fingers crossed!
9 November 2025
Assignment of Master UDI-DI to contact lenses becomes mandatory
What’s happening? The two-year transition period of assigning Master UDI-DI for contact lenses ends on 9 November 2025. Then the application of the Master UDI-DI becomes obligatory.
Who’s impacted? Manufacturers 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 extension seems unlikely for this deadline specified in legislation. Recently MDCG published a guidance document to help implement the Master UDI-DI rules for contact lenses (link).
By end of 2025
Completion of the targeted evaluation of the MDR and IVDR
What’s happening? European Commission intends to complete the targeted evaluation of the MDR and IVDR by end of 2025. Before that, there is a public consultation to gather feedback on the MDR and IVR implementation. The consultation is open from 12 December 2024 to 21 March 2025. You can find it here. An evaluation report and Commission adoption is scheduled for Q4 2025.
Who’s impacted? Depending on the European Commission’s evaluation report, the targeted evaluation may result in changes to the MDR and IVDR. That can impact for example notified bodies, manufacturers and competent authorities.
Probability it’ll happen? The targeted evaluation has so far followed the timeline the Commission has set for the actions. Therefore, meeting the completion deadline looks to be on course at this point.
I hope this checklist of MDR dates and deadlines for 2025 helps you avoid any hassle that may result from missed due dates.
If you have any questions about these dates and deadlines – whether they apply to you, or what you need to do by a certain deadline – feel free to send me message.
I’m always happy to listen to what’s on your mind and help you take the next step.
