Why are CE and IVD Important in Your Selection of a Cryovial?
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CE IVD certification may be an important factor in the selection of a cryovial. Invitro Diagnostic Devices or IVD’s are medical products which can be used to carry out tests on samples taken from the human body such as blood, urine or tissue to produce a diagnostic result. The IVD Directive (IVDD) 98/79/EC aims to set quality standards for IVD products which will help protect patients and clinicians.
A CE mark is a symbol applied to products to confirm that they conform to relevant EU directives. For IVD devices this will be the IVD Directive (IVDD) 98/79/EC.
Why Should You Look for CE IVD Tubes?
The answer to this is relatively straight forward, if you are looking to use cryovials for any diagnostic application, then your tube must be CE IVD certified. You can also take comfort in knowing that the tube manufacturer has taken the responsibility to ensure that the product can be used for Invitro Diagnostic applications even if this was not the anticipated use when first storing the sample.
Furthermore, even if you do not think that your biobank needs these tubes right now, with new expected standards in the future, choosing a CE IVD tube now, will help future-proof samples.
What About Other Laboratory Plastics?
The CE IVD certification only applies to those products which are destined specifically for In Vitro Diagnostic use. There can be some confusion regarding which products fall into this category, but general research products are likely not to require CE IVD labelling. If you need further clarification on this, then please complete for form below.
