EU | Substantial modification Documents for Performance Studies under Regulation (EU) 2017/746
Please login to view this page.
EU | Performance Study Application/Notification Documents Under Regulation (EU) 2017/746
Please login to view this page.
EU | Guidance on Periodic Safety Update Reports (PSURs) According to the EU MDR
Please login to view this page.
USA | New FDA Guidance on the Content of Human Factors (Usability) Information in Medical Device Marketing Submissions
Please login to view this page.
USA | FDA Publishes Final Guidance on Procedures for Handling Post-Approval Studies Imposed by PMA Order
Please login to view this page.
USA | FDA Publishes Final Guidance for Medical Device Postmarket Surveillance (522 Order)
Please login to view this page.
GERMANY | BfArM Tightens Data Protection Requirements for DiGAs
Please login to view this page.
AUSTRIA | New NIS Classification Guidelines for Medical Devices
Please login to view this page.
EU | Notice to Manufacturers to Ensure Timely Compliance with MDR Requirements
Please login to view this page.










