Seven Types Of Scrutiny: A Tangled And Costly Web Ahead For Device Makers
This article was originally published in SRA
The 'scrutiny' procedure of high-risk devices is one of the most controversial points in the proposed EU regulations for medical devices and IVDs. But medtech manufacturers look to be facing not just one but seven types of regulatory scrutiny across the two proposed regulatory texts. Moreover, the different scrutiny procedures could apply cumulatively to some products. In the Q&A below, medtech regulatory expert, Gert Bos, explains why this matter needs to be addressed urgently.
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