European Commission
The article highlights the key points related to the manufacturers’ obligations in case of product supply being interrupted or discontinued.
Austria
The article provides a general overview of the regulatory framework for combination products applicable in the EU in general and in Austria specifically.
EU
The new article describes in detail the relevant harmonised standards applicable to medical devices, and also the way they should be applied.
EU
The new article describes in detail the approach to be applied when it comes to the re-assessment of designation under the new regulatory framework.
EU
The new article highlights certain specific aspects associated with designation, such as notification procedure or changes to the scope of designation.
Gartner® Market Guide for Life Science Regulatory Information Management Solutions
Download NowGartner® Market Guide for Regulatory Intelligence Solutions
Download Now
