In 2023, the European Union introduced Regulation (EU) 2023/607, which extends the transitional provisions for specific medical devices. This extension is accompanied by detailed conditions outlined in Articles 120(2) and (3) of the current version of the Medical Device Regulation (MDR). For a comprehensive understanding, we encourage you to consult the official documents linked below this article.

One of the critical conditions mandates the submission of a formal application for an MDR conformity assessment to the Notified Body by May 26, 2024 (as per Article120(3C (e)) of MDR). For those who have not yet taken action, we stress the urgency of meeting this deadline to ensure compliance.