We are pleased to announce the publication of the Notified Body Confirmation Letter! This letter is an essential document that manufacturers can use to demonstrate the extension of the additional transitional period for their legacy devices with expired MDD certificates, as permitted by the regulation EU 2023/607 amending the Medical Device Regulation (MDR).
The European Commission has provided helpful guidance in Question 7 of the Q&A document, available at this link. Among other solutions, additional evidence could be provided by a confirmation letter issued by the notified body. While some notified bodies may have reservations about the last sentence of their involvement, it is important to note that they have collaborated extensively to create a harmonized version of the confirmation letter. You can find the harmonized template here.
With the last sentence, the Commission has suggested that this confirmation letter be provided free of charge "Such confirmation letter could be based on a harmonised template and be issued, in principle, without extra costs". However, it is important to recognize that while the letter itself may not incur an additional cost, notified bodies may have different pricing structures throughout the MDR certification process.
We appreciate the diligent efforts of Team NB in promptly developing a harmonized template for the confirmation letter. This standardized approach will help ensure clarity and consistency for manufacturers seeking to benefit from the extension of the transitional period for their legacy devices.