Post Market Surveillance
and Adverse Event Reporting

Course Outline Suitable for anyone who has a part to play in Vigilance and Post Market Surveillance (PMS), this course focuses on practical advice and workshops that will improve your organisation’s performance in this area. Topics studied include the terminologies of PMS (proactive) and Vigilance (reactive); European and FDA regulatory requirements; recalls and field safety notices; and when, how and where to report adverse incidents. We also look at Post-Market Clinical Follow-up (PMCF), which is increasingly the focus for manufacturers entering the market with new devices. The course explains the PMCF requirements, how to evaluate the need for PMCF, and the best approach for designing PMCF plans. By the end of the course, you should understand all the regulatory requirements for PMS and Vigilance, and have a better idea of how to integrate PMS and PMCF activities into your EN ISO 14971 risk management cycle. As a result, you should be better placed to meet your regulatory obligations effectively.

Topics covered

  • EU Regulatory requirements for PMS, including recalls, field safety notices and vigilance
  • Post-Market Clinical Follow-up requirements and Notified Body expectations
  • The impact of the Medical Device Regulation on PMS activities
  • FDA regulations 21 CFR part 803 Medical Device Reporting, part 806 Reports of Corrections and Removals and part 822 Post Market Surveillance
  • Responsibilities for Post-Market Surveillance
  • Guidance documents for PMS and Vigilance
  • Key elements of PMS (proactive) and Vigilance (reactive)
  • The correlation between PMS and principles of EN ISO 14971 “Application of risk management to medical devices”
  • Exchange of information: PMS databases e.g. MAUDE and EUDAMED
  • Study Group II of the IMDRF (formerly GHTF)
  • Legal, warning letters, shutdown & Medical Device Alerts implications

Outcomes
At the end of the seminar, delegates will gain an insight into:

  • European and FDA Regulatory requirements for Post Market Surveillance and Vigilance
  • When, how and to whom to report adverse incidents
  • Recall requirements and reporting
  • Use of Field Safety Notices, Field Safety Corrective Actions, Dear Doctor Letters
  • Guidance documents available
Connect with us

Toll free 1-877-623-8742 or 317-706-1493

Maetrics Ltd
Blenheim Court
Huntingdon Street
Nottingham
NG1 3BY
United Kingdom (UK)

Nottingham/Europe HQ +44 115 921 6200

Basel +41 61 511 4930

For questions regarding Maetrics services, please email information@maetrics.com.