View of a Notified Body on the rules of the new MDR
FHI, Federation of Technology Industries – November 24, 2020
The new Medical Devices Regulation (MDR) will come into effect on May 26, 2021. Natascha Cuper, product reviewer at Notified Body DARE!! Medical Certifications will introduce you to this new legislation in its presentation. It also discusses which requirements in the new Medical Devices Regulation (MDR) differ from the current legislation in the Medical Devices Directive.
A notified body is an inspection or testing institute that must test products to see whether they meet the applicable guidelines. Notified bodies are designated by the government. DARE!! is a notified body and will take you through the role they play in the certification process of a medical device and how a product application for certification works. Read more…