EU
The article highlights the aspects related to studies involving combination products, the ones not initially intended to assess the safety and performance of a medical device, and other specific cases.
EU
The new article highlights the aspects related to the existing regulatory pathway, the approach to be applied for different types and classes of medical devices, and the way the intended purpose of the device in question should be considered.
EU
The new article highlights the aspects related to the content of the clinical investigation report, discusses additional considerations associated with the transitional period, and explains the status of a legal representative.
EU
The article provides an overview of the provisions of a guidance document and highlights the key points to be taken into consideration by medical device manufacturers (software developers).
Africa
This article highlights what CE marking is, how to obtain it, and the steps to follow to comply with EU regulations. Table of Contents Medical devices manufacturers willing to market products in the European Union (EU), must comply with the regulations established...
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