The IDS 2025 trade fair in Cologne has come to a close, providing us some interesting insights on the challenges the medical device sector will face in the coming years in relation to MDR certification.

During the latest edition of IDS – International Dental Show, held in Cologne at the end of March, we had the opportunity to engage with manufacturers and industry professionals, gathering a clear signal: many companies are still delaying the preparation and submission of their technical documentation, leading to the risk of serious repercussions in the coming years.

WHY IS IT CRUCIAL TO SUBMIT TECHNICAL DOCUMENTATION ON TIME?

As Notified Body no. 1282, ECM Medical Devices assesses the conformity of devices with regulatory requirements, but it is the manufacturer’s responsibility to provide the technical documentation promptly for evaluation.

Regulation (EU) 2017/745 (MDR) demands stricter requirements and greater accuracy in documentation, lengthening the evaluation timelines. The extension granted by Regulation (EU) 2023/607 has allowed more time for manufacturers, but the continued postponement of submissions is creating a domino effect. This could lead to a critical overload for Notified Bodies by 2028. If technical files are submitted en masse only in the final available months, the result may be longer certification timelines and delays in accessing the European market, potentially disrupting the continued marketing of many devices.

This trend, also highlighted in the latest Team-NB Survey Report, is a phenomenon that ECM is closely monitoring. As Notified Body, we urge manufacturers not to underestimate this situation: updating and submitting technical documentation in a timely manner helps prevent critical issues and ensures a more efficient evaluation process.

TAKE A PROACTIVE APPROACH TO THE CERTIFICATION PROCESS

Currently, ECM Medical Devices is evaluating a significant number of technical files, yet the volume of documentation received so far remains lower than expected. If the current tendency to delay persists, the risk is a sudden surge in requests over the coming years. Such a bottleneck would inevitably lead to extended evaluation times.

For this reason, we encourage manufacturers to carefully plan their timelines. Taking a proactive approach to the certification process not only helps avoid critical issues but also provides an opportunity for companies to strategically position themselves in the market, preventing delays that could affect the continuous marketing of their devices.

Our team is available to engage in a structured dialogue and start the certification process for your device right now!

Contact us at:Diego Stevanella diego.s@entecerma.it | Marzia Pellegrini marzia.p@entecerma.it