Month: December 2020

BfArM informs about damages to hip implants

December 13, 2020

BfArM informs about damages to hip implants caused by high-frequency cauterizing instruments BfArM, the German Federal Institute for Drugs and Medical Devices, has issued a recommendation in connection with high-frequency… Read More

Key guidance document on the classification of IVDs under the IVDR

December 1, 2020

by Michael Sander

The European Commission has published a key guidance document on the classification of in vitro diagnostic medical device (IVD) under Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)… Read More

Month: December 2020

BfArM informs about damages to hip implants

Key guidance document on the classification of IVDs under the IVDR

Complete Download Section mdi Europa

bsi develops guidelines for the application of ISO 14971 to artificial intelligence and machine learning

The IVDR and performance evaluation studies