Rule 5: IVD or not IVD?
A complex question reaches us often: the question about products for general laboratory use.
Manufacturers of laboratory equipment for the examination of human samples often want to market them under IVDR but often don’t fulfil the two most essential requirements:
Firstly, the product must meet the requirements to be classified as a medical device (MDR) and secondly as an IVD product (IVDR). It must be intended for a specific medical purpose and provide diagnostic information about an individual patient. If one of both requirements are not met, your device is not regulated by either the MDR or the IVDR.
What does this mean for IVD manufacturers? Regardless of whether it is a PCR cycler, ELISA analyser or sequencer: without a specific IVD application, your device is “only” for general laboratory use and not regulated by the IVDR.
What can you do to get clarity? Prepare the intended purpose with great care!
It is like the foundation on which your TD is built. If it wobbles, the whole house will soon collapse. On the other hand, you will benefit from a precisely formulated intended purpose. The clearer you are about what claims you want to prove, the easier it will be for you to write your documents (clinical/performance evaluation).
Please find a more elaborate article on this subject on our partners’ website.