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.
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 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.
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.
Download the MDR Quality assurance Certificate here