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

Each month, our regulatory team contributes to DM Experts by writing articles for the DM Expert flash, the regulatory monitoring tool distributed every month.

Find the following articles this month:

• ANSM: request for advertising authorization for DM and DMDIV written by Lauriane Sauge
  [2023-06-09] (Open access) On June 9, 2023, the ANSM updated its application form for prior authorization of advertising for medical devices (MD) and in vitro diagnostic medical devices (IVDM)…
• EUDAMED: latest update of the IUD and PRODUCTION user guide written by Lauriane Sauge
  [2023-06-12] The European Commission published on June 12, 2023 the latest update of the EUDAMED UDI (Unique Device Identifier) and PRODUCTION guide for…
• HAS: DMN evaluation flowchart written by Lisa Deleyrolle
  [2023-06-19] (Open access) The National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS) updated in April 2023, the flowchart for the evaluation of digital medical devices (DMN)…

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. If you have any questions regarding your technical documentation or your quality management system, we have set up a free service allowing you to ask your questions directly to our regulatory team.