Global Medical Device Reporting – A Comparison of Worldwide Regulations
Why Should You Attend:
Two of the top five most common 483s have to do with Medical Device Reporting. Warning letters have been given for late MDR reports. Regulatory agencies worldwide struggle with limited resources so they are moving towards a risk based approach. A very important way they assess risk is through the Medical Device Reports and Medical Device Vigilance reports.
This session will review the regulations surrounding complaints and medical device reporting and their recent updates. Definitions of what to report, timing and format requirements all differ between regions of the world. This training will help you make sure your teams are up to date on the regulations. This training will outline what is expected, when you are expanding into a new region, and how to integrate medical device complaint handling from the new region into your already existing process. Complaint handling and medical device reporting is always reviewed by FDA inspectors and notified body auditors alike. Attending this session can help you assure that your company’s process for complaint handling and medical device reporting should is robust. It is the cornerstone of you post market surveillance process.
Areas Covered in the Seminar:
- Review of terms
- Medical Device Reporting
- Medical Device Vigilance
- Malfunction
- Serious injury
- Incident
- Review of Global Regulations
- US
- Canada
- Europe
- Australia
- Japan
- Manufacturer
- Importer
- User Facilities
- Who Reports
- Decision Trees – when to report
- Timing requirements
- Comparison of format of reports
- Regulatory agencies next steps
- Requests for additional information
- Trigger an inspection
- Request a recall
- Special topics
- Capital equipment
- Similar products
- Maude Database
- Social Media
- eMDR
- Alternative Summary Report (ASR)
- Remedial Action Exemption (RAR)
