Feb 19, 2024
EU
The article describes in detail the regulatory approach to be applied in the context of the importation and distribution of medical devices in the EU, focusing on the obligations of the parties involved.
Read More
Feb 19, 2024
EU
The article highlights the key points associated with interpreting specific regulatory provisions of the current European legislation in medical devices.
Read More
Jan 2, 2024
CHMP
The article highlights the key points associated with the regulatory framework for specific categories of medicinal products.
Read More
Jan 23, 2023
Europe
The article highlights the key points related to the qualification of medical devices for the purpose of determination of their regulatory status, and also provides additional details regarding the most important concepts used. Table of Contents The UK Medicines &...
Read More
Oct 20, 2022
Europe
The article provides an overview of the regulatory policy to be applied to software products and highlights the key points associated thereto. Table of Contents The Medicines and Healthcare products Regulatory Agency (MHRA), the UK regulating authority, has published...
Read More