BTA's response to the publication of the MDCG classification guidance document

On 4 October, the MDCG guidance document on classification of medical devices (MDCG 2021-24) was published to define classification rules under the new Medical Device Regulation (MDR).

In BTA’s view, the final guidance document still leaves room for interpretation related to the wording of the definitions and examples of Rule 2 and Rule 14 and whether blood bag sets containing citrate-based anticoagulant solutions would be classified as Class IIb or Class III medical devices. 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. 

The purpose of this position paper is to demonstrate why citrate-based anticoagulant solutions should not be understood as medicinal products and consequently why blood bag sets incorporating these anticoagulant solutions should stay as Class IIb medical devices, in line with public health needs. Click here to access the position paper

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