Module 16 2022

05/09/2022

EUDAMED & Databases

• Clinical Investigations • Single ID numbers for Investigations

• Submission of all applications and notifications for Investigations • Exchange of information relating to clinical investigations between Member States and between them and the Commission • Information provided by the Sponsor, including the report and its summary • Reporting on adverse events and device deficiencies

The Organisation for Professionals in Regulatory Affairs

23

EUDAMED & Databases

• Vigilance and Market Surveillance • Manufacturers reports on serious incidents and field safety corrective actions • Manufacturers Periodic Summary Reports • Manufacturers Trend Reporting • Periodic Safety Update Reports (PSURs) (for Class III and IIb) • Manufacturers Field Safety notices • Information to be exchanged between Member States / Compentent Authorities / Commission • There will be relevant links to the UDI Database

The Organisation for Professionals in Regulatory Affairs

24

12