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.
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).
EU MDR/IVDR
The Council of the European Commission concluded in a meeting on December 9th to address member states’ concerns over the challenges and issues in meeting current EU Medical Device Regulation (MDR) deadlines. Table of Contents Regulatory Background According to...
EU MDR/IVDR
The new article highlights the key points related to a change of authorized representative, as well as the ones related to responsible persons and marketing surveillance. Table of Contents The Medical Device Coordination Group (MDCG), an advisory body of the European...
