Articles of the month written for Flash DM Experts (July 2023)

Below are links to articles written for the DM Experts flash:

• European Commission: Updated factsheet on MDR/IVDR for third country authorities by Lauriane Sauge
  [2023-07-17] (Open Access) The European Commission published on 17 July 2023 the updated factsheet on medical devices and in vitro diagnostic medical devices for non-EU and non-EEA countries.
• Updated questions and answers on practical aspects related to the implementation of Regulation (EU) 2023/607 written by Lisa Deleyrolle
  [2023-07-18] The European Commission updated on 18 July 2023 the questions and answers document on practical aspects related to the…
• NBCG-Med: validation of the Team-NB confirmation letter template written by Lauriane Sauge
  [2023-07-17] (Open Access) As a reminder, a model confirmation letter recording a formal request, written agreement and appropriate monitoring under Regulation (EU) 2023/607 on transitional provisions for certain medical devices (MDs) has…

Published every month, the DM Expert flash is the reference in terms of regulatory monitoring. We are delighted to be able to contribute through our monitoring work by proposing subjects in line with the regulatory and normative news of medical devices, but also through the editorial work to provide subscribers with useful and adapted articles.

These analysis missions go hand in hand with the regulatory and quality support that we provide on behalf of our medical manufacturing and subcontracting clients. As an ICA certified auditor, we can also carry out an internal audit (QMS according to ISO 13485 and 21 CFR Part 820 and technical documentation).