Draft standardisation request as regards medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
Posts published in June 2019
Guidance Document – Pre-market Requirements for Medical Device Cybersecurity
Marketing Clearance of Diagnostic Ultrasound Systems and Transducers
Mandatory reporting requirements for hospitals
Industry Perspective on the Implementation Status of the MDR/IVDR
New information about upcoming MDR and IVDR regulations added to the page – Medical devices: guidance for manufacturers on vigilance
Clinical Investigations for Prostate Tissue Ablation Devices
Expanded Access for Medical Devices
European Commission expert panels on medical devices and in vitro diagnostic devices