MDCG 2024-16 reporting form for device shortages published
The Medical Device Coordination Group (MDCG) issued MDCG 2024-16, Manufacturer Information Form on Interruption or Discontinuation of Supply of certain medical devices and certain in vitro diagnostic medical devices.
The document follows the amending Regulation (EU) 2024/1860. As described in our November newsletter issue, it introduced under article 10a of Regulations (EU) 2017/745 and 2017/746 (MDR and IVDR) the obligation of economic operators to alert competent authorities and the market in the case of interruption or discontinuation of the supply chain for certain devices. MDCG 2024-16 provides a report form that economic operators should use when shortage of certain devices becomes visible.
The document can be found here: Click