BTA's Position Paper on up-classification of blood bag sets

Misalignment on the interprestion of the changes in the classification rules in the new Medical Devices Regulation (MDR)  may lead to an up-classification of blood bag sets from class IIb to class III. In fact, the European Commission has recently published its draft MDCG guidance document on the medical device classification rules of the MDR, where all blood bag sets containing an anticoagulant are classified as class III medical devices. Until now, under the existing framework of the Medical Device Directive (MDD) most blood bag sets are classified as class IIb. 

This poses a particular challenge from a public health perspective. Blood bag sets have demonstrated a high level of safety for decades, and their use for the collection of donor blood is being regulated strictly. An up-classification would require additional resources and time, which could limit the ability of manufacturers to adapt blood bag sets to customer needs in a timely and efficient manner.  It would create a risk in terms of availability and cost of blood bag sets and, ultimately, result in a delay in providing blood products to patients in need. The current trends of decreased blood donation as a consequence of the challenges posed by COVID-19 underline the importance of ensuring sufficient blood supply throughout Europe.

Therefore, the BTA have published a position paper denoting the perspective of blood bag sets manufacturers on this up-classification and the effect it could have on public health. Click here to access the position paper

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