The Blood Transfusion Association (BTA) is pleased to announce the release of its position paper on the Proposal for Substances of Human Origin (SoHO) Regulation.
In BTA's view, the classification guidance document still leaves room for interpretation as to how blood bag sets containing citrate-based anticoagulant solutions should be classified.
The proposed up-classification of blood bag sets under the new Medical Devices Regulation (MDR) from class IIb to class III due to misalignment on the interpretation of the changes in the…
The BTA has developed two position papers. The first underlies the concern of BTA members that the envisaged timeframe for sunsetting the use of DEHP would hamper the availability of blood bag sets…
We use cookies on blood-transfusion-association.com (e.g. tracking and analytical cookies), with which an analysis and measurement of user data is possible. Further information can be found in the
