EU - form for reporting of interruption or discontinuation of supply

On December 6 the MDCG published MDCG 2024-16 and an associated Annex that contain the form for reporting according to Article 10a of MDR and IVDR and an table in case more than one device (model) is affected. The respective Q&A document has not yet been updated at this time.

Manufacturers should consider this form when integrating the requirements of Article 10a into their quality management system.