What is Post Market Clinical Follow Up?
Post Market Clinical Follow Up refers to the active collection of data about the clinical experience with the device following market release. These activities may include an analysis of existing device registration data to perform a new clinical study. Medical device manufacturers are advised by American and European regulatory requirements to include PMCF in their Post Market Surveillance Plans. Why? Because the clinical data collected in the pre-market stage may not be sufficient to detect rare events and incidents. To identify unknown and new risks, it is essential to continue clinical follow-up after the market.
The Post Market Clinical Follow Up (PMCF) study is mandatory –
- If the device is CE marked and no clinical study has been conducted so far.
- Constructional materials, substances, principles of operation, technology or medical indications are novel.
- Any significant changes or change in intended use for which premarket clinical evaluation and re-certification has been completed.
- Constructional materials, substances, principles of operation, technology or medical indications are novel.
- High-risk devices based on design features, materials, components, invasiveness, clinical procedures.
- High-risk anatomical locations (if applicable).
- Target populations such as paediatrics and the elderly.
- The severity of disease and treatment challenges.
- No data about long-term safety and performance of device usage.
- Negative results from any previous clinical investigation, including adverse events or from post-market surveillance activities.
- Identification of previously unstudied subpopulations which may show different benefit-risk ratios e.g. hip implants in different ethnic populations.
- Continued validation in cases of discrepancy between reasonable premarket follow-up time scales and the expected life of the product.
- Risks identified from the literature or other data sources for similar marketed devices.
- Interaction with other medicinal products or treatments
- Verification of safety and performance of the device when exposed to a more extensive and more varied population of clinical users.
- The emergence of new information on safety or performance
- Where CE marking was based on equivalence
- For Non-CE marked devices, which is available in the market since a year ago and there exists residual risk.
