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 actions, but to a large extent on companies’ proactivity in providing the necessary technical documentation.

THE CRITIACL IMPORTANCE OF DEADLINES AND DATA QUALITY

The issuance of an MDR certificate is a complex process, the duration of which largely depends on the completeness of the technical file. Incomplete or poor-quality documentation inevitably generates non-conformities that temporarily halt the assessment, thereby extending delivery times. 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.

RESPONSABILITIES AND CONTRACTUAL CLAUSES

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.

A PARTNERSHIP FOR SUCCESS

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.