Post Market Surveillance and Vigilance

Who should attend

This introductory course is of value to employees at all levels within the organisation of Medical Device manufacturers, and suppliers to the Medical Devices industry including:

• Members of the Senior Management Team
• Regulatory Affairs Officers
• Manufacturers/Testers
• Regulatory Affairs Managers
• Regulatory Affairs Officers
• Internal Auditors
• Clinical Affairs Specialists
• Quality Assurance Managers
• Marketing and Sales Professionals

Course Outline

This practical and informative course covers all aspects of Vigilance and Post Market Surveillance including recalls and field notices and how and when to inform Competent Authorities of information that comes to light as part of your company’s vigilance and PMS activities. This often misunderstood subject area is typically poorly implemented resulting in regulatory obligations not being effectively met. This course will define the terminologies and explain the concepts of PMS and vigilance systems. Punctuated with practical workshops designed to illustrate the important principles, this course is suitable of anyone who has a part to play in Vigilance and PMS.

Throughout the course, tips and guidance will help develop a robust PMS systems that meet the regulatory requirements as well as identify and effectively use the relevant guidance documents to maintain compliance. The course also highlights the importance of PMS as an integral part of a company’s Risk Management cycle (ISO 14971) as well as the practical applications and integration into the lifecycle of a medical device.

While the course will focus on European regulations for PMS and Vigilance System on Medical Devices including the IVDs it will also reflect on the requirements of other regulatory agencies such as the FDA.

Topics covered

• European Regulatory requirements for PMS, including recalls, field advisory notices and vigilance
• Responsibility for Post-Market Surveillance (PMS)
  • Competent Authorities
  • Notified Bodies
  • Authorized Representation
  • Manufacturers
• The requirement of PMS in Own Brand Labeling –Original Equipment Manufacturer Technical Agreement
• Guidance documents for PMS and Vigilance
• Key elements of PMS (pro-active) and Vigilance (reactive)
• The correlation between PMS and Principles of ISO 14971 “Application of risk management to medical devices”
• Requirements of ISO13485, Quality Management Systems standard for regulatory purposes
• Feedback of PMS data into the risk management process
• Other Regulatory requirements – e.g. US MDRs
• Exchange of information: PMS databases e.g. MAUDE and EUDAMED
• The Study Group II of the IMDRF (formerly GHTF)
• Implications for not meeting the requirements (legal, warning letters, shutdown, Medical Device Alert)

Outcomes

Upon completion of the course candidates will be able to:

• Appreciate, know and understand of the main requirements of the PMS and Vigilance System
• Integrate PMS into a quality management system
• Design an effective and robust PMS system appropriate to the QMS to meet the regulatory requirements
• Write and operate a vigilance procedure to meet regulatory requirements
• Understand the principles and practice of risk management as set out in the ISO 14971 which requires the input of PMS
• When to report a vigilance incident
• Events that are not reportable
• Who to report a vigilance incident to
• How to report a vigilance incident