In 2020, the European Commission published its draft MDCG guidance document on the medical device classification rules of the MDR, where all blood bag sets containing an anticoagulant would be classified as class III medical devices. Under the previous framework of the Medical Device Directive (MDD) most blood bag sets are classified as class IIb.
The draft guidance specifies that “Blood bags incorporating Heparin or other medicinal substances as anticoagulant agents” would be class III. This proposed up-classification of blood bag sets under the new MDR from class IIb to class III is due to misalignment on the interpretation of the definition of medicinal substances.
Blood bag sets in the EU are almost exclusively circulated with a citrate based anticoagulant solutions. Heparin is very different from the CPD anticoagulant solutions being typically used in standard blood bag systems across Europe. Citrate solutions used in the collection, processing and storage of blood and blood components are specifically intended for use outside the human body (not intended for direct intravenous administration) and are nor presented (nor used) as having properties for treating or preventing disease within the human body. They are designed for ex vivo anticoagulation. As such, it is the position of BTA that citrate as a substance should not be considered as medicinal product per Directive 2001/83/EC (point 2 and point 10 of Article 1).
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. A potential up-classification may impose challenges on public health, as such a process would require additional resources and time, limiting the ability of manufacturers to provide such blood bag sets to patients within the proper timeframe, and potentially hampering the availability of blood products. It is for this reason that the BTA advocates that citrate anticoagulant is not a medicinal product, and that blood bag sets incorporating these substances should retain their class IIb classification. More information on the BTA’s position on the matter can be found here.