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.
EU
The article highlights the key points associated with interpreting specific regulatory provisions of the current European legislation in medical devices.
EU
The new article highlights the aspects related to the existing regulatory pathway, the approach to be applied for different types and classes of medical devices, and the way the intended purpose of the device in question should be considered.
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.
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...
RegDesk is recognized as a Regulatory Intelligence Representative Vendor! Learn more by reading the 2024 Gartner® Market Guide for Regulatory Intelligence Solutions.
Get the report
