EU
The new article describes in detail the applicable classification approach and highlights the key considerations associated thereto.
CHMP
The article highlights the key points associated with the regulatory framework for specific categories of medicinal products.
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...
Asia
This article highlights key medical device regulations to know in 2023 and their implications for the industry. Table of Contents In the ever-evolving landscape of healthcare, medical device regulations play a vital role in ensuring the safety, efficacy, and...
EU MDR/IVDR
This article highlights the fundamentals of EU medical device regulation, highlight the top priorities for 2023, and explore how individuals and organizations can become more involved in the changing landscape. Table of Contents The European Union (EU) has implemented...
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