bsi article on clinical evaluation requirements under the MDR

Notified body bsi has published an article in February in the Journal of Medical Device Regulation. In this article, bsi is sharing insights on its perspective on how manufacturers should look at the clinical evaluation requirements laid out in Regulation (EU) 2017/745 on medical devices (MDR).

The 19-page document provides valuable insights and also considers guidance documents that have been published by the Medical Device Coordination group (MDCG).

The article is publicly available and may be downloaded from bsi’s website.

Source: bsi 

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