The European Medical Device Regulation (MDR 2017/745) and the Paul Ehrlich Institute (PEI) requirements set strict standards for blood bags used as primary packaging in Advanced Therapy Medicinal Products (ATMPs). These Class IIb medical devices must comply with substance restrictions, biocompatibility assessments, and stability validation to ensure product integrity during cryopreservation, storage, and transportation.
With the upcoming phase-out of DEHP (Di(2-ethylhexyl)-phthalat )-containing materials by 2030 (Regulation (EU) 2023/2482), manufacturers face significant challenges in selecting alternative plasticizers, maintaining biological product stability, and ensuring full compliance with MDR and GMP requirements.
At Valicare, we enable you to meet these evolving requirements. We provide regulatory expertise, risk assessments, validation strategies, and technical documentation to ensure the safe and compliant use of blood bags for ATMPs.
Our Expertise in Blood Bag Compliance for ATMPs
- Regulatory Compliance Support
We assist in interpreting and implementing MDR requirements for blood bags, ensuring full compliance with Annex I (General Safety and Performance), Annex II (Technical Documentation), and Annex XIV (Substance Restrictions under REACH).
- Risk Management (EN ISO 14971)
We conduct comprehensive risk assessments to mitigate potential hazards associated with material modifications, cryopreservation, and interaction with ATMPs, ensuring patient and product safety.
- Biocompatibility Assessment (ISO 10993)
Our biocompatibility evaluations ensure that alternative plasticizers meet MDR and PEI requirements, preventing leachability, cytotoxicity, and adverse interactions with biological components.
- Process Validation and Qualification
We support material validation, shelf-life studies, and functional testing of blood bags used for cryopreserved and fresh ATMPs, ensuring consistency in sterility, integrity, and product stability.
- Supplier Management
Our team assists in the qualification and monitoring of suppliers, ensuring that blood bag manufacturers comply with MDR, GMP, and PEI guidelines, reducing supply chain risks.
- Extensive Expertise in ATMP Manufacturing
Valicare has extensive experience in GMP services for ATMPs, including risk management, process validation, and regulatory compliance. We understand the complexity of biological materials and provide tailored solutions for ATMP manufacturers.
- Strong Background in Transfusion Medicine
With expertise in blood bank auditing, we ensure that the sourcing, handling, and processing of blood-derived materials meet the highest quality and regulatory standards, providing a seamless transition from blood banks to ATMP production.
Why choose Valicare?
Navigating the evolving regulatory landscape of blood bags for ATMPs requires expertise, precision, and strategic foresight. Ensuring compliance with MDR and PEI requirements while transitioning to DEHP-free materials presents unique challenges that demand specialized knowledge and tailored solutions. At Valicare, we combine regulatory expertise with practical industry experience to help you stay ahead of compliance risks, streamline validation processes, and ensure the highest standards of safety and performance. With our extensive knowledge of ATMPs, transfusion medicine, and medical device regulations, we offer end-to-end support to accelerate your market access while maintaining regulatory compliance and product integrity.
Don’t waste time, contact us today!
