Feb 1, 2024
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.
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Feb 1, 2024
EU
The new article describes in detail the applicable classification approach and highlights the key considerations associated thereto.
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Jan 18, 2024
EU
The new article highlights the aspects related to the timelines associated with the clinical investigations, the way they should be calculated, and other relevant matters.
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Jan 2, 2024
CHMP
The article highlights the key points associated with the regulatory framework for specific categories of medicinal products.
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Nov 3, 2023
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).
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