Module 16: Post Market Surveillance and Vigilance for Medical Devices

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Defines the terminology and explains the concepts of vigilance and post market surveillance (PMS) for medical devices, and their practical applications and integration into their lifecycle.

Overview

This module covers EU requirements for PMS, including recalls and vigilance, as well as the role of competent authorities (CAs), notified bodies (NBs), manufacturers and other economic operators in this area with reference to relevant guidance documents.

It also covers key elements of proactive PMS; the role of the person responsible for regulatory compliance; tailoring PMS systems to specific products, including drug-device combinations and IVDs; and the requirements of EN ISO13485, the quality management standard for medical devices.

Learning outcomes

Knowledge and understanding

Successful students will typically:

  • Critically evaluate the requirements and guidance for PMS
  • Critically evaluate the requirements and guidance for vigilance
  • Possess a systematic understanding and critical awareness of the European requirements including legislation, guidance and associated documentation relating to surveillance and vigilance for medical devices.

Skills and attributes

Successful students will typically:

  • Critically appraise a PMS system and make recommendations on the implementation of such a system
  • Be able to make recommendations about vigilance procedures
    • Demonstrate the ability to critically analyse the legal requirements relating to surveillance and vigilance
  • Critically appraise and evaluate communications from competent authorities, notified bodies, economic operators and other stakeholders relating to the conduct of surveillance and vigilance.

Developing expertise across the medical device lifecycle? Consider:

  • Module 12: Data Management and Digitalisation in Regulatory Affairs
  • Module 14: Design, Development and Certification of Medical Devices
  • Module 16: Post-Market Surveillance and Vigilance for Medical Devices
  • Module 17: Regulatory Strategy in the Post Market Phase

Expanding your options? Consider:

  • Module 18: Drug-device Combinations and Other Technologies
  • Module 21: US Regulation of Medical Devices
  • Module 22: Regulatory Requirements for Cell, Tissue and Gene Therapies