Air Products is proud to announce that it has been awarded Medical Device Regulation (MDR) EC Mark certificate for Medical Device liquid nitrogen for the UK.
Do I need MDR liquid nitrogen?
It depends on your application. If it involves the storage of human tissue samples the chances are that you do. This includes any applications that use liquid nitrogen for preserving blood and bone marrow cells, sperm, ova, early embryos, and, in the microbiology laboratory, a variety of microorganisms (bacteria, fungi, etc) Another application that requires MDR liquid nitrogen is cryotherapy, which refers to the focal application of extreme cold for the in-situ destruction of abnormal or diseased tissue.
What does MDR Device liquid nitrogen actually mean?
Liquid nitrogen that could come into contact with life science samples through cryogenic storage or cryotherapy is classified as a class IIa medical device, compliance with the 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)
• general safety and performance requirements are met, including for 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)
• manufacturers have a person responsible for regulatory compliance in place (Article 15 of the MDR and IVDR)
I have heard of the Medical Device Directive (MDD) but what is the Medical Device Regulation (MDR)?
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 have completed months of work to ensure that liquid nitrogen manufactured and supplied within the UK complies with the new more comprehensive Medical Device Regulation.
I need MDR liquid nitrogen, how can I get it?
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.
More information: www.airproducts.expert/uk/biomedical/medical-device-regulation
Get in touch: firstname.lastname@example.org
Jackie Taylor: TAYLOJ14@airproducts.com