EUDAMED: Important considerations for ensuring preparedness and compliance
£25.00
Stay ahead of the curve with critical guidance on ensuring your EUDAMED compliance strategy is both effective and timely
English
The European database on medical devices (EUDAMED) is considered the digital backbone for the European Union’s (EU’s) regulatory framework for medical technologies – Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). EUDAMED is pivotal for the overall functioning of the framework and serves as a comprehensive repository for information relating to the entire lifecycle of medical devices that meet the provisions of the MDR or IVDR to be placed on the Union market. In this article, Olga van Grol-Lawlor and Frank Matzek summarise the objectives of EUDAMED’s six distinct but interconnected modules, clarify the current deployment timeframes, and explain what information will be publicly accessible. They also recommend points to consider when developing a EUDAMED strategy, including methods for communicating data to EUDAMED.
Specification: 18 pages plus covers, in English, supplied by email as a PDF.
This article has been published in the February 2024 issue of the Journal of Medical Device Regulation.
