Module 16 2024

21/10/2024

PMCF Activities: Generic v Specific

PMCF Activities can be broadly categorized into “Generic” and “Specific”.

Generic PMCF Activities Generic PMCF activities involve broad approaches to gathering information and typically include:

• Gathering clinical experience from physicians and other healthcare professionals.

• Feedback from users, such as patients.

• Screening scientific literature for relevant studies and data.

• Other sources of clinical data, which might include published data on similar devices

These activities often produce subjective datasets that may not be sufficient alone to confirm the device’s safety and performance to the required standards.

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PMCF Activities: Generic v Specific

PMCF Activities can be broadly categorized into “Generic” and “Specific”.

Specific PMCF Activities

Specific PMCF activities are more targeted and can produce scientifically valid datasets. These include:

• Post-market interventional clinical investigations.

• Evaluation of data from suitable registries.

• High-Quality Prospective Surveys

• Investigator-initiated studies.

• Case Cohorts and other subject-specific clinical data collection activities

These activities are based on patient cases where the device is used in practice, providing robust data that can be used to document clinical safety and performance of the device.

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