Medical device classification in the area of blood

Backgrounders & Fact sheets

This paper provides information on the legal frameworks covering medical devices (not in-vitro diagnostics) associated with the collection, processing, and storage of blood and blood components. Four product groups are presented along with the classification rules that have been applied according to the current Medical Devices legislation and guidance. The results of a Eucomed member survey show that, currently the majority of their products are classified as Class IIb. A section on donor safety and potential for solutions miss-connections is presented. Eucomed members, and other interested stakeholders are working together on a new connector design to ensure this risk is reduced. Finally, some points are listed on considerations for future application of classification rules regarding this group of products. Eucomed’s position on classification for medical devices in the area of collection, processing and storage of blood and blood components is that the current rules in the Medical Devices Directive are appropriate to ensure safety. However, considering emerging medical device technologies, especially solutions, further clarification of the rules will enable better understanding and harmonization of the applicable rules.