Since the Medical Device Regulation (MDR) was published in 2017, we witnessed many changes and deadline postponements. It is also likely that there will be more in the future. For medical device manufacturers, the most significant change has been the extension of the transition periods. For the MDR and EUDAMED. Some medical device companies expressed concerns that their industry would not be ready for the deadline. The European Commission addressed these concerns to avoid a shortage of medical devices.

Recently, the European Commission proposed a further change to the MDR, which was endorsed by the European Council shortly after. The EUDAMED is to be published in stages. Manufacturers would have to complete their preparations earlier than previously expected. In addition, a crucial deadline for applying for the conformity assessment procedure ends in May 2024. Both points are reason enough to think about early MDR preparation.

Gradual release: will EUDAMED become mandatory earlier?

On January 23, 2024, the European Commission published a proposal. On February 21st this proposal was supported by the European Council via a press release. According to it, many IVD tests do not yet comply with the requirements of the In-Vitro Diagnostics Regulation (IVDR). As a result, the Council gives manufacturers more time to comply and supports transition periods for various risk classes.

The press release also promotes the transparency of EUDAMED and proposes accelerating its launch. It aims to publish the six EUDAMED modules in stages. Accordingly, the individually completed modules should be mandatory after an audit phase. Previously, the audit was not planned until the completion of all modules. The document mentions a deadline at the end of 2025.

Application deadline for Notified Bodies ends soon

There are currently two different challenges with regard to Notified Bodies for medical device manufacturers. On the one hand, there is still a shortage of Notified Bodies. There are 43 Notified Bodies certified for the MDR and only 12 for the IVDR (as of 26.02.2024). This figure contrasts with 75 at the time of the Medical Device Directive (MDD) and 19 bodies for the IVDD. In the course of the MDR, Notified Bodies were subject to more intensive inspections by national authorities, as a result of which some appointments were revoked. This discrepancy creates an overload for the remaining bodies. Manufacturers can, therefore, expect a much longer certification period.

Secondly, the application period for medical and in-vitro device manufacturers with the Notified Bodies will soon end. According to EU Regulation 2023/607, it ends on May 26, 2024, which may further increase the exhausted capacity of the Notified Bodies. One Notified Body expressed concern that many manufacturers are unaware of this deadline and could, therefore, miss it. As a result, a large number of applications would arrive at the already overloaded Notified Bodies in a short space of time.

What measures can I take?

• Revise the MDR implementation plan: Manufacturers should revise their MDR implementation plan. What steps are required to maintain MDR compliance? For which products does the transition period change? What actions do I need to take to ensure my plan is aligned with the upcoming changes?
• Carry out an intended/actual analysis: Building on the previous point: What are my planned measures, and when do they need to be completed? What do I need for this, and what personnel capacities are required? Is the capacity available internally, or does it make sense to outsource processes? What additional tools do I need to manage this?
• Start early with MDR certification: Manufacturers should take care of the MDR certification of their products as early as possible. The relevant transition periods and a potentially long waiting time at the Notified Bodies must be taken into account.
• Adapt internal processes: For example, how do I deal with the Post Market Surveillance or the UDI module of EUDAMED if they become mandatory earlier? What do I need to adapt within the company? Early integration of these processes is helpful, as some employees may need training.
• Work with Notified Bodies: Good contact with a Notified Body is important for MDR compliance. Manufacturers should, therefore, contact a Notified Body at an early stage in order to start the approval process.
• Prepare for the EUDAMED modules: Some EUDAMED modules, such as Actor and UDI, are already usable. We recommend starting with the Actor module. Here, all user roles are created and managed. It is also important to collect the relevant data for the UDI module in advance. Afterward, I have to decide how to transfer the data to EUDAMED. Since the European Council has endorsed the Commission’s proposal, it is important to deal with this at an early stage.
• Follow the developments of the MDR Regulation: Due to its complexity, MDR stakeholders’ readiness varies, and they are often not sufficiently equipped to deal with it. As a result, the EU authorities are making changes. Manufacturers should keep up to date with the latest changes and prepare accordingly.

Start now

Manufacturers of medical devices should take these steps for MDR preparation to be sufficiently equipped to deal with the challenges posed by Notified Bodies. This is because they present medical device manufacturers with a major task. Manufacturers who follow the above recommendations can minimize delays in the approval of their products and ensure that their products meet the requirements of the MDR.

When preparing for EUDAMED, it is especially advisable to bring a suitable partner on board. At tracekey, we can help you with the UDI/medical device registration module. Our solution can simplify your data management considerably. If you are interested, please get in touch with us.