In October 2023, the European Commission extended the transition period for EUDAMED’s introduction. The system was supposed to be fully functional in the second quarter of 2024. This and other deadlines have now been postponed by three years.
The EU has not published an official explanation. However, it has been known for some time that Notified Bodies are overburdened, which has an impact on the operationality of manufacturers. In addition, the complexity of some modules may have been underestimated. The extension of the EUDAMED transitional periods will have a particular impact on manufacturers.
The most important dates
In addition to the date for full functionality, the mandatory use of the six modules has been postponed. The timeline is adjusted as follows:
|Old Date||New Date|
|EUDAMED full functionality||Q2 2024||Q2 2027|
|Mandatory use of the Actor, Market Surveillance, Vigilance, and Clinical Investigation/Performance Studies modules||Q4 2024||Q4 2027|
|Mandatory use of the UDI/Medical Devices Registration, and Certificates/Notified Bodies modules||Q2 2026||Q2 2029|
The EU plans to complete the first five modules by the second quarter of 2024. Namely: Actor, Market Surveillance, Vigilance, UDI/Medical Devices Registration, and Certificates/Notified Bodies Modules. The Clinical Investigation/Performance Studies module will then be completed by the beginning of the third quarter of 2026. Parallel to this, the first five modules will undergo an audit. The audit for the last module, as well as an audit of all modules in conjunction, will take place six months after its completion (Q4 2026-Q12027). An official EU report will be published, followed by a six-month transition phase. As a result, the mandatory use of the first four modules begins (Q4 2027), followed by an 18-month transition for the last two (Q2 2029).
Reasons for the extension of the EUDAMED transition period
The extension of the transitional period is 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 re-certification of many medical devices. Conversely, manufacturers would find it difficult to properly register their products in the EUDAMED without any fault on their behalf.
- 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 EU timeline, you will notice that the Clinical Investigation/Performance Studies module will only be developed after the other modules. Given the previous postponements, it is obvious that the EU did not expect the complexity that EUDAMED displays.
Unfortunately, there is a lack of transparent communication from the EU Commission. 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 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 have fewer human resources 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 system.
All important information on the MDR and its transitional periods can also be found on our website.[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: November 2023)