The transition to Regulation (EU) 2017/745 (MDR) represents one of the most significant challenges for medical device manufacturers. However, the success of the process depends not only on the performance of the Notified Body but, to a large extent, on the proactivity of companies in providing the necessary technical documentation.

THE CRITICAL IMPORTANCE OF DEADLINES AND DATA QUALITY

MDR certification is a complex process, the duration of which largely depends on the completeness of the technical file. Incomplete or poor-quality documentation inevitably leads to non-conformities that temporarily halt the assessment, extending the time to issuance. To avoid bottlenecks and ensure business continuity, it is essential to submit all materials as soon as possible. In this regard, ECM requires all legacy device manufacturers to submit their documentation no later than December 31, 2026.

RESPONSABILITIES AND CONTRACTUAL TERMS

It is important to note that failure to comply with submission timelines relieves the Notified Body of any liability regarding the failure to issue certification before the end of the transitional period.

Furthermore, it should be emphasized that the deadline for the extension of Class III legacy devices is December 31, 2027; therefore, it is essential to submit the documentation IMMEDIATELY.

ECM wishes to remind you that it is available to accept the transfer of new MDR applications for legacy devices, within the scope defined by the Notified Body itself.

A PARTNERSHIP FOR SUCCESS

The shared goal is to achieve certification within the established timelines. To facilitate this process, open collaboration is essential: a structured dialogue with the Notified Body can accelerate file submission and clarify any procedural questions. We invite all manufacturers to promptly confirm their expected submission dates to ensure smooth and prioritized handling of their application.