Q&A concerning the practical aspects of Manufacturers’ Obligation to Inform in case of Interruption or Discontinuation of Supply of certain Medical Devices and IVDs

The European Commission has also published a Q&A document on the practical aspects of the notification obligations provided in Article 10a of the MDR and the IVDR concerning interruption in supply or discontinuation of supply of certain medical devices and how these should be fulfilled.  

 Te Q&A document includes a clarification that the devices that fall within the scope of Article 10a include all models or types of devices that have been placed on the EU market and for which it is reasonably foreseeable that a supply interruption or discontinuation could result in serious harm or a risk of serious harm to patients or public health in one or more EU Member States.