MDCG 2024-16: Manufacturer Information Form on Interruption or Discontinuation of Supply of certain medical devices and certain in vitro diagnostic medical devices

The recently released MDCG 2024-16 introduces the Manufacturer’s Information Form, a critical step toward enhancing transparency and communication regarding medical device supply interruptions and discontinuations in the European market. This form ensures that manufacturers notify authorities, healthcare professionals, and other stakeholders about potential supply issues, supporting patient safety and regulatory compliance. By enabling timely notifications, it allows healthcare providers and distributors to adapt their supply chains and maintain access to essential medical devices and IVDs. These updates strengthen the EU’s medical device regulatory framework, emphasizing efficiency and safety while mitigating risks of device shortages.