Finally got my copy of this interesting book on grey literature, which has great impact on medical device regulatory compliance.
One of the definitions of grey literature is: “Grey literature stands for manifold document types produced on all levels of government, academics, business and industry in print and electronic formats that are protected by intellectual property rights, of sufficient quality to be collected and preserved by libraries and institutional repositories, but not controlled by commercial publishers; i.e. where publishing is not the primary activity of the producing body.”
So how does it impact medical device regulatory compliance? Grey literature is where a lot of data comes from nowadays. On processes like Clinical Evaluation, PMS and Biological Evaluation, although you would only use quality data from peer reviews and other sources to come to conclusions, you can (and should) use grey literature to drive your activities. In the case of PMS, you will also need to use grey literature to conclude on some aspects. As grey literature is not “tracked” by a publishing company (including peer reviewing), it is really important to have a well define and rigorous process to plan, search, appraise and make conclusions on grey literature.
Also, here is a list of grey literature sources, adapted with information the the clinical evaluation MEDDEV, EU MDR and ISO standards.
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