Delay in implementation of Medical Devices Regulation puts availability of blood bag sets at risk

Due to various regulatory and legislative requirements, placing a non-DEHP product by the May 2025 sunset date will be close to impossible for blood bag set manufacturers. If a non-DEHP product was developed by January 2022 and the CE marking process was started with the relevant Notified Body, it would still require around 2 years to be granted CE marking. What is more, once a blood bag set receives the CE marking, it still needs to go through the relevant national level validation processes as per the Blood, Tissues and Cells directives which can take up to 3 years depending on the Member State. In this theoretical scenario, a non-DEHP product would thus be ready to be used by blood centres around mid-2027 – 2 years past the DEHP sunset date. This presents a serious threat to the European blood supply, presenting high risks to public health.  

Under REACH, the continued use of DEHP after the sunset date will only be permitted if authorisation is granted. The legislation allows users to apply for authorisation (AfA) to continue using substances included in the Authorisation List (Annex XIV of REACH). Because of the lengthy regulatory requirements, there is an increasing likelihood that an AfA will have to be completed in order to ensure the continued use of DEHP until non-DEHP products can be introduced to the EU market. 

The already challenging  timeframe is exacerbated by the delayed classification decision. The long-awaited MDCG classification guidance document under the new MDR is still to be published by the European Commission. Manufacturers thus do not yet have definitive guidance on whether they will remain in Class IIb or Class III. This may further delay timelines for manufacturers to get the CE mark for non-DEHP products before the sunset date, as the certification process cannot fully start until class is determined.  

The BTA has been in close contact with key stakeholders, including the Commission and Competent Authorities, to put forward arguments that citrate-based anticoagulant solutions (e.g. CPD and CPDA-1) should not be considered a medicinal product and consequently, these blood bag sets should remain in class IIb. 

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