November “In All Other News”: New MDCG Guidance, Updates from Team NB, and more
3 December 2024
UK MHRA Publishes New 2024-2026 Roadmap of Future Regulations
11 December 2024Background
For an overview of the MDR/IVDR Article 10(a) requirements, please read: Newly Published – Q&A on Obligation to Inform of Device Interruption or Discontinuation
Article 10(a) becomes effective starting 10 January 2025.
Overview
The MDCG has published a Manufacturer Information Form, to be used when reporting supply interruption or discontinuation. It is available: HERE
It is straightforward and fairly intuitive. If you have already developed a procedure on how to comply with Article 10(a) requirements, then it can be updated to reference this new form (and its annex).
A link to the form has also been added to the following Casus resource: Regulations & Guidance Documents
