Despite some delays, the final EUDAMED deadline is not far off. Its scope remains challenging for manufacturers. The requirements of the Medical Device Regulation (MDR) are overwhelming, there are not enough capacities in the company, and the budget is also tight. At the same time, there is uncertainty about further potential changes to the MDR. However, many manufacturers are now focusing on uploading their UDIs. What if there was a quick and easy solution for this in the form of an EUDAMED solution?

Thanks to our experience in highly regulated industries, we know what matters. Significant changes toward compliance are often less effective than smaller, consistent efforts. EUDAMED is not a one-time giant project but requires long-term activities. However, there are currently some larger hurdles to overcome, which take more time as they are still new. One of these hurdles is the UDI module. Here, new processes need to be developed within the company, and large amounts of data must be collected in advance and entered into EUDAMED. Our UDI Manager helps to facilitate these processes.

EUDAMED Go-Live: The Countdown is On

There is no fixed date yet to release the UDI module of EUDAMED. However, there is a timeline from the European Commission (EC) indicating mandatory use in the first quarter of 2026. This date derives from statement in the FAQ on the phased release of EUDAMED published in November 2024. It states that the UDI module will become mandatory six months after the confirmation of functionality.

The functionality will be announced in the Official Journal of the European Union. The EC expects the first four modules, including the UDI module, to be completed between the second and third quarters of 2025. In the best case, manufacturers still have about a year of time until their products finally have to be entered into EUDAMED. If this is not done after the six-month transition period, the respective products cannot be placed on the EU market. To be MDR-compliant, it is therefore advisable to start entering the UDIs as soon as possible.

What to Consider When Achieving Compliance

Due to its complexity, the MDR affects all areas of the company. It can uncover previously neglected aspects, such as insufficient information exchange within the company or lack of digitization. Non-standardized data storage also becomes immediately apparent. Data is stored on many different servers and hard drives, making it difficult for employees to find it. This can be frustrating, especially when collecting product master data for EUDAMED. In more than 10 years of transformation consulting in the regulatory context, we have gained valuable insights into this area:

• EUDAMED distinguishes between “can” and “must.” Not all data needs to be entered to achieve compliance. If you are satisfied with the minimum requirement, you can save time and money. A software-based EUDAMED solution can be helpful for this.
• Learn from the experience of others. From the perspective of medium-sized businesses, it seems logical to want to solve the MDR challenge on your own. However, this impulse should be viewed critically. It is often more sustainable and cost-effective to benefit from external help and their experiences rather than reinventing the wheel alone.
• Secure external resources early. The closer the deadline gets, the scarcer external resources become. Waiting too long can result in software providers and consultants lacking the capacity for new customers. Medical device manufacturers should therefore not delay the search for a suitable partner.
• Act with a future-oriented approach today. The implementation of the regulations has a project character in many companies. However, after that, the MDR becomes a continuous process. Reporting requirements and already established networks will not disappear on the deadline. It is advisable to look for a partner for long-term planning.

Product Data Validation

The next step in EUDAMED compliance is collecting the correct data. Looking at the number of possible entries, it is easy to lose track. Additionally, it is not immediately clear which attributes are mandatory, voluntary, or only required in certain cases. If there is uncertainty in this regard, the mytracekey UDI Manager provides support. The integrated pre-validation according to the EUDAMED Business Rules checks your UDI data for completeness and specifically highlights errors. Lengthy searches in large documents are prevented, saving significant time.

How tracekey Helps You

The implementation of the Medical Device Regulation poses great challenges not only for manufacturers but also for the EU. The numerous delays are a clear sign of this. Actors must familiarize themselves with the new portal, collect the necessary data, enter it into the database, and maintain it thereafter. As the responsible person, you can quickly become overwhelmed. We aim to counter this with our EUDAMED solution for every level of requirements. This allows you to capture, manage, and easily send medical device data to EUDAMED. The various subscriptions are also tiered so that there is a suitable model for every UDI volume. Setting up a direct connection to EUDAMED in the form of an M2M connection is also possible.

Are you still looking for an EUDAMED solution? Book the UDI Manager directly in our shop or schedule a non-binding demo.