Once a medical device enters the market it must continue to meet all the regulatory, safety and performance requirements and standards that were required for its approval.
Depending on regulatory jurisdiction and device classification your obligations may vary. Differing terminology and interpretations of the regulations is also difficult.
The FDA, MDR and TGA define post-market surveillance as an active, prospective, systematic, and scientifically valid process of collecting, analysing and interpreting data from the actual use of medical devices for the purpose of identifying a need to apply any necessary corrective or preventive action.
Post-market vigilance is a reactive system that forms part of the post-market surveillance system. It refers to the reporting of serious incidents, adverse device effects, field safety corrective actions and recalls.
If regular market surveillance does not provide sufficient data, post-market clinical follow-up (PMCF) studies may be required. The MDR regards post-market clinical follow-up as part of post-market surveillance system. The MDR states that “The manufacturer shall undertake to institute and keep up to date a post-market surveillance plan, including a post-market clinical follow-up”.
If the PMS reveals information requiring changes to be made to the clinical evaluation, an update must be made. PMCF studies collect clinical data with the immediate aim to update and enhance clinical evaluations.
Our Services:
- Process mapping of PMS stakeholder roles (internal or contracted) and workflows
- Development and implementation of standard operating procedures and policies
- Development and implementation of bespoke PMS software solutions
- Literature and media reviews, signal detection, analyses, and reports
- Customer feedback surveys
- Mandatory incident and adverse event reporting
- Complaint handling
- Recall management
- Qualification of third-party vendors
Post-Market Surveillance System
