EU: Confirmation Letter Regulation (EU) 2023/607 Released By The Team Notified Body (NB)

ARQon
May 19, 2023
1 min read

Updated: May 30, 2023

The Regulation (EU) 2023/607 was released on 15 March 2023 with the extension of the transition period and removal of the ‘sell-off’ period announcement comes together with the press releases statement, factsheet and Q&A, which is yet subject to certain conditions being met. Regulation (EU) 2023/607 is a preventive initiative to avoid medical devices shortage and ensure a high level of public health protection and patient safety while the amendment transitional of Regulations (EU) 2017/745 and Regulations (EU) 2017/746 happen.

One of the queries among the industry stakeholders is how the manufacturers may demonstrate their certificate validity during the transitional period. As stated by the European Commission in the Q&A, Notified Body cannot issue new MDD/AIMDD certificates but may release a written statement verifying the existing information in the certification.

Therefore, the European Association for Medical Devices of Notified Body (TEAM-NB) released harmonized template of the “Confirmation Letter” on 7 May 2023. The Notified Body will issue the ‘Confirmation Letter’ in the letterhead including the device specification information and manufacturer information. The manufacturer may request the Notified Body to issue the ‘Confirmation Letter’ if require to prove the certificate validity with zero cost.

Besides, it is important to note that the Confirmation Letter can only be issued by the Notified Body as certificate validation proof if the MDD/AIMDD certification expires before 20 March 2023 and only if the manufacturer has applied for MDR and while waiting for approval, the manufacturer has dealt agreement with the Notified Body.

Source: Team-NB