Medical Devices – USA/Europe Regulatory Updates round up – Aug 2021
EUROPE
1. Clarification on “first certification for that type of device” and corresponding 1. Clarification on “First Certification for That Type of Device” and Related Procedures for Notified...
ANSM publishes a preventive management, distributors, FDA Conduct of Clinical Trials of Medical Products, FDA Export Certification, first certification for that type of device, generating devices under the Pest Control Products Act, Guidance for notified bodies, Medical Devices Regulatory Updates, MHRA shared guidance for manufacturers of devices, SARS-CoV-2 in vitro diagnostic medical devices