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 Notified Body’s performance but largely on the proactivity of companies in providing the necessary technical documentation.

MDR TIMELINES AND TECHNICAL FILE QUALITY 

The issuance of an MDR certificate is a complex process, the duration of which is largely dependent on the completeness of the technical file. Partial or low-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 manufacturers of legacy devices to submit their documentation no later than December 31, 2026.

MDR MANUFACTURER OBLIGATIONS AND TIMELINES

It is important to note that non-compliance with submission deadlines exempts the Notified Body from responsibility should certification not be granted before the transition period expires.

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.

PARTNERSHIP AND STRATEGIC PLANNING

Our common goal is reaching certification on schedule. To streamline this journey, open cooperation is key: maintaining a structured dialogue with the Notified Body can speed up the submission process and resolve procedural doubts. All manufacturers are encouraged to provide timely confirmation of their planned submission dates to guarantee priority and seamless management of their files.