The European Commission extended the EUDAMED transition period in December 2024. The system was supposed to be fully functional in the second quarter of 2024. This and other deadlines have now been postponed with the last announcement. Additionally, on January 06, 2023, the European Commission (EC) published a proposal for the extension of the MDR (Medical Device Regulation) transition periods. This proposal was already adopted on February 16, 2023, bringing the extension into force. The obligation of medical device manufacturers to be MDR compliant was thereby postponed several years into the future. Reason for this decision was the MedTech industry’s fear that many companies would be unable to meet the original deadline. As a result of the previous deadlines, many medical devices would have lost their marketing authorization, ultimately, with serious consequences for patients in need.
The EU has not published an official explanation for either of the two extensions. However, it has been known for some time that Notified Bodies are overburdened, which has an impact on the operationality of manufacturers. The complexity of some modules may have also been underestimated. The EUDAMED and MDR transition period have been extended and they will have a particular impact on manufacturers.
EUDAMED: important dates
In the latest publication, the development and analysis of the Clinical Investigation/Performance Studies module was postponed to the future for the time being. A concrete timeline is not available. In addition to the date for full functionality, the dates for the mandatory use of the six modules have already been postponed in a previous announcement. The new timeline is as follows:
| New Date | |
| EUDAMED full functionality except of Vigilance, and Clinical Investigation/Performance Studies modules | Q2 2025 |
| Full functionality of Vigilance Module | Q4 2025 |
| Mandatory use of the Actor, Market Surveillance, Vigilance, UDI/Medical Devices Registration und Certificates/Notified Bodies Modules | Q1 2026 |
| Mandatory use of the Vigilance Module | Q3 2026 |
| Full functionality and mandatory use of the Clinical Investigation/Performance Studies Module | TBD |
The EU plans a gradual roll-out of the first four modules starting in the second quarter of 2025. These include: Actor, Market Surveillance, UDI/Medical Devices Registration, and Certificates/Notified Bodies. Subsequently, the Vigilance module is to be completed by the beginning of the fourth quarter of 2025. Once the modules have been audited, they are declared fully functional in the Notice Publication. The transition phase of six months then starts for each module. After that, their use is mandatory. If a product is already on the market before the end of the transition period, this is extended by a further six months. Thereafter, the mandatory use of the modules also applies to these medical devices, meaning 12 months after they have been declared fully functional.
The audit for the vigilance module will take place six months after its completion (Q2-Q3 2025). This will be followed by the publication of an official EU report and a six-month transition phase.
Reasons for the extension of the EUDAMED transition period
The extension of the transitional period is possible due to various factors. These mainly include the overburdened Notified Bodies and the development time of the six EUDAMED modules:
- Problems with the Notified Bodies: The Notified Bodies, which are responsible for testing and certifying medical devices, are struggling with issues related to the implementation of the new EU Medical Device Regulation (MDR). According to the regulation, the Notified Bodies must be revalidated themselves, along with around 24,000 MDD-approved products. Furthermore, observing the EU database for Notified Bodies, you will find only 40 entries with approval for the MDR. In comparison, there were still 75 bodies under the MDD in 2013. Due to this discrepancy, there are delays in the recertification of many medical devices. Conversely, manufacturers would find it difficult to properly register their products in the EUDAMED without any fault on their behalf. (As of October 2023)
- Extended development time for the modules: Originally, EUDAMED was supposed to be fully functional as early as May 2020. However, this date was postponed, and a staggered release was introduced. Full functionality was therefore announced for the end of 2023. This date has now been postponed again. If you look at the current EUDAMED timeline published by the EC, you will notice that the Clinical Investigation/Performance Studies module will still be in development after the other modules have become mandatory. Given the previous postponements, it is obvious that the EU did not expect the complexity that EUDAMED has reached.
Unfortunately, there is a lack of transparent communication from the EC. Instead of openly explaining the reasons for the extensions, manufacturers and future users are being presented with a fait accompli. A further postponement would therefore not be inconceivable.
Consequences for manufacturers
EUDAMED’s extension has various implications for manufacturers of medical devices. However, they are not necessarily negative. Due to the postponement, they now have more time to adapt to the new requirements of the EU Medical Devices Regulation and the EUDAMED system. This affects the following areas in particular:
- Registration of medical devices and Notified Bodies in the EUDAMED system
- Submission of data for clinical trials and performance studies
- Establishment of a post-market surveillance system for medical devices
The extension of the EUDAMED transition period also reduces the stress for manufacturers who would only have been able to implement the new requirements by the original deadline with a great deal of effort. This can be particularly true for small and medium-sized companies. As they usually have fewer employees and the MDR is more complex than many could have anticipated, it may have been pushed back in their priorities.
The EUDAMED transition period extension comes as good news for manufacturers in the MedTech sector. Nevertheless, the MDR and its database should not be neglected. Even if the mandatory use of EUDAMED still seems a long way off, it is crucial to be well-prepared. This is demonstrated not least by the fact that the EU is overwhelmed with its own system.
New MDR deadlines
To avoid a shortfall in patients’ care, the proposal to extend the MDR transition deadlines has been adopted by the European Commission. The new deadlines are as follows:
| Product classes | Old date | New date |
| Class Is, Im, Ir | – | December 31, 2028 |
| Class IIa | May 26, 2024 | December 31, 2028 |
| Class IIb non-implantable | May 26, 2024 | December 31, 2028 |
| Class IIb implantable | May 26, 2024 | December 31, 2027 |
| Class III | May 26, 2024 | December 31, 2027 |
Only legacy devices are affected by these dates, i.e., those with a certificate or declaration of conformity issued before May 26, 2021, under European Council Directives 90/385/EEC or 93/42/EEC. In addition, there are important conditions attached to the new deadlines:
- Still compliant with MDD/AIMDD
- No significant change to the product
- Product does not pose an unacceptable risk to patients
- Quality management system according to Article 10(9) established by 26.05.2024 at the latest
- Conformity assessment according to MDR requested by 26.05.2024, written agreement with a Notified Body no later than 26.09.2024
In the context of this decision, the previously established sell-off deadline of 27 May 2025 was canceled. It also entailed the risk of a supply shortage. Manufacturers can now sell medical devices already placed on the market before 26 May 2021 without any time restriction and do not have to worry about a recall or possible disposal.
Furthermore, it should be mentioned that the deadlines for UDI marking remain unchanged.
What is important now?
Even though the transition periods have been postponed, that does not mean that manufacturers can now rest. Considering that the conformity assessment has been requested for only 8.120 products as of November 2023, there may be another backlog. This number does not even represent half of the 21.376 medical devices approved for the market under the Active Implantable Medical Devices Directive and the Medical Devices Directive up to this point. Although the capacities of the notified bodies have been increasing, and will increase by non-legislative measures. However, the 26 notified bodies missing in November 2023 will presumably be accredited soon, while the deadlines of the transition periods are tight nevertheless.
Even though the transition deadlines have been pushed back, collecting the necessary data on your products is still important. The data of the medical devices currently have to be entered into the database several years before their MDR certification. With our software solution, mytracekey MedTech we can help you to manage your product data efficiently and easily achieve MDR compliance.
If you are interested in the master data pre-validation of your UDIs or our MedTech solution, contact us here and book a software demo.
[Disclaimer]
This information is only one possible interpretation of the regulations. They are also in a constant state of change, so the information in this article may be incomplete or out of date. The above article is expressly no legal advice. Please refer to the official documents for information before making any business decisions. (Status of information: April 2025)