MDR-Certified Liquid Nitrogen
Leading the Way as the UK's Only Industrial Gas Manufacturer of MDR-Certified Liquid Nitrogen
The Medical Device Regulation (MDR) CE Mark with EC Declaration of Conformity (DoC) for medical device liquid nitrogen signifies our commitment to maintaining the highest standards of quality and safety in our products. This certification assures customers in the medical and healthcare industries that Air Products liquid nitrogen meets stringent regulatory requirements, ensuring its suitability for use in medical applications.
Interested in learning more about our liquid nitrogen supply and delivery services?
Visit our Liquid Nitrogen Supply & Delivery page for more information.
Importance of MDR-Certified Liquid Nitrogen for Medical Applications
Medical facilities, research laboratories, biotechnology companies, and any other entities
involved in medical applications or procedures that require the use of liquid nitrogen may
be required or prefer to use MDR-certified liquid nitrogen.
This certification ensures that the liquid nitrogen meets stringent regulatory standards for
medical devices, making it suitable for use in medical treatments, research, and diagnostic
procedures.
Understanding the Need for MDR-Certified Liquid Nitrogen
The necessity for MDR-certified liquid nitrogen depends on your specific application. Typically, if your work involves storing human tissue samples, such as blood, bone marrow cells, sperm, ova, or embryos, MDR liquid nitrogen is essential.
Additionally, cryotherapy, which involves the precise application of extreme cold for tissue destruction, also requires MDR-compliant liquid nitrogen.
Understanding MDR Device Liquid Nitrogen
MDR Device liquid nitrogen refers to liquid nitrogen used in cryogenic storage or cryotherapy that falls under Class IIa medical device classification. Compliance with the Medical Device Regulation (MDR) ensures that manufacturers adhere to stringent criteria, including correct classification, meeting safety and performance requirements, providing clinical evidence, and appointing a person responsible for regulatory compliance.
Compliance with the Medical Device Regulation (MDR) means that we as the manufacturers need to ensure that:
- The device has been correctly classified against the new risk classification criteria (Annex VIII of the MDR and IVDR)
- The general safety and performance requirements are met, including labelling, and technical documentation and quality management systems (Annex I of the MDR and IVDR)
- Increased requirements for clinical evidence are met (Annex XIV of the MDR and IVDR)
- The manufacturer has a person responsible for regulatory compliance in place (Article 15 of the MDR and IVDR)
Understanding the Transition from MDD to MDR
The Medical Device Regulation (MDR) replaced the Medical Device Directive (MDD) in May 2021,
offering a more comprehensive and detailed framework with a stronger focus on product
safety. While the MDR is four times longer than its predecessor, it builds upon existing
requirements without removing any provisions from the MDD.
Air Products has dedicated months to ensuring that our liquid nitrogen complies with the new
regulations, guaranteeing adherence to the enhanced Medical Device Regulation standards.
Frequently Asked Questions
If your work involves the storage of human tissue samples, the chances are that you are required to use MDR-certified liquid nitrogen. This includes any applications that use liquid nitrogen for preserving blood and bone marrow cells, sperm and ova, early embryos, and microorganisms.
Liquid nitrogen that could come into contact with life science samples through cryogenic storage or cryotherapy is classified as a Class IIa medical device.
The MDR replaced the MDD in May 2021. The MDR is substantially more comprehensive and detailed compared to the MDD. The MDR document is four times longer than the MDD and puts more emphasis on product safety. Nothing from within the MDD has been removed, rather the MDR has only added new requirements.
Air Products is currently the only industrial gas company manufacturing liquid nitrogen in the UK that complies with the new MDR, contact us today to discuss your requirements.
Liquid Nitrogen Supply & Delivery
Interested in finding out more about MDR-Certified liquid nitrogen supply and storage?
Visit
our Liquid Nitrogen Supply & Delivery page for more information.
The right fit for you and your samples
From gas supply to laboratory design, installation, sample storage, training and ongoing maintenance and support, we're here to help you find the optimum cryogenic storage for your needs. Start by using this interactive selector guide to find the right options for you.
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