The MDCG published the presentations from the MDCG “Extraordinary” meeting that occurred on 24 April 2024: HERE
Team Notified Body published results from their annual sector survey: HERE
Results from recent surveys were published in the Redacted Update on the study on monitoring availability of medical devices.
If you have been following the Commission’s Notified Body capacity and MDR/IVDR surveys, you may be familiar with the first part of the presentation. However, it also includes data from the industry survey to manufacturers and authorized representatives.
Slide 33 also notes a pilot survey to health service providers is planned May/June 2024.
Also published was the Competent Authority Task Force’s presentation on device shortages.
The presentation discusses the new proposal to require manufacturers to provide advance notice, if they expect any interruption to the supply of critical devices. In particular, Competent Authority actions related to it, including:
Per slide 6, some preliminary steps are targeted for completion before end of May 2024.
Team Notified Body (“Team NB”) published the results of its annual sector survey. This is an internal survey organized by Team NB, for Team NB members.
Below are some highlights from the survey:
To combat the last bullet point, Team NB recommends manufacturers refer to their Technical Documentation Best Practice guidance documents for MDR applications and IVDR applications.
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