Commission publishes decision on classification of blood bag sets

On 4 October, the Medical Device Coordination Group (MDCG) published the long-awaited guidance document on classification of medical devices under the new Medical Device Regulation (MDR). The final guidance document still leaves room for interpretation whether blood bag sets containing citrate-based anticoagulant solutions would be classified as Class IIb or Class III medical devices. 

The wording of the definitions and examples of Rule 2 and Rule 14 states that a blood bag set is classified as a class III product if it contains a substance which can be considered a medicinal product if used separately and has an action ancillary to that of the device. However, the classification guidance document does not provide clarification to Rule 14 relating to these definitions and states that clarification is expected to be published in the separate Guidance document covering the borderline between medical devices and medicinal products. As such, there is still considerable uncertainty as to when the classification of blood bag sets will be clarified.  

Unless clarification is provided by the upcoming borderline guidance document, the current classification guidance will likely leave manufacturers having to enter into separate classification discussions with their relevant competent authorities. For this reason, the upcoming borderline guidance document should clarify the definition of medicinal products in medical devices. 

It is the view of BTA that this clarification should also clearly specify citrate-based anticoagulant solutions as falling outside the scope of the definition of a medicinal product and consequently why blood bag sets incorporating these anticoagulant solutions should stay as Class IIb medical devices, in line with public health needs. Therefore, the BTA will publish an official position paper in the near future to respond to the classification guidance document and to express its view ahead of the publication of the MDCG guidance on borderline between medical devices and medicinal products.  

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