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EU Notified Body

A notified body is an independent organisation designated by an EU country to assess the conformity of products before being placed on the market. Under EU MDR 2017/745, the notified body is also called a conformity assessment body.   A conformity assessment body (CAB) or a notified body is responsible for carrying out the conformity assessment procedure mentioned in the applicable Regulation. What does a notified body do? A notified body assesses whether the product conforms to the require...
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Vigilance Terms and Concepts as Outlined in the Regulation (EU) 2017/745 on Medical Devices

According to European Union Medical Device Regulation (EU MDR) the term “Vigilance” is the identification, reporting and trending of serious incidents and the conduct of safety-related corrective actions (Market surveillance and vigilance). An ‘incident’ as per article 2(64) MDR is any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supp...
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