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The Post-Market Imperative: Understanding the requirements for effective post-market clinical follow-up

As provided by the MEDDEV 2.12-2,REV.2, the circumstances under which PMCF may be necessary are as follows:

• Innovation: the device’s design, materials, substances, principles of operation, technology or medical indications are novel
• Significant changes to the product or to its intended use for which pre-market clinical evaluation and re-certification has been completed
• High product-related risk
• High-risk anatomical locations
• High-risk target populations (e.g., children, elderly)
• Severity of disease/treatment challenges
• Questions of ability to generalize clinical investigation results
• Unanswered questions of long-term safety and performance
• Results from any previous clinical investigation, including adverse events
• Results from post-market surveillance activities
• Identification of previously unstudied subpopulations which may exhibit different benefit/risk-ratio (e.g., hip implants in different ethnic populations)
• Continued validation in cases of discrepancy between reasonable pre-market follow-up time scales and the expected life of the product
• Risks identified from the literature for other data sources for similar marketed devices
• Interaction with other medical products or treatments
• Verification of safety and performance of device when exposed to a larger and more varied population of clinical users
• Emergence of new information on safety or performance
• Where CE marking was based on equivalence (i.e., circumstances whereby the manufacturer demonstrated conformity to the relevant essential requirements by means of substantial equivalence to similar devices, and no long-term clinical safety and performance data on the device itself was provided for its indications prior to CE marking)

While this list is not all-inclusive, registered Notified Bodies are equipped to assess manufacturers’ PMCF plans, their proposed execution, as well as the assessment of a manufacturer’s justifications that PMCF is not necessary.

Notified Bodies have always performed the following for specific medical devices:

• Verified need for PMCF as part of PMS based on residual risks
• Verified PMCF is conducted when clinical evaluation was based exclusively on data from equivalent devices for initial conformity assessment
• Assessed appropriateness of any justification for no PMCF
• Assessed appropriateness of proposed PMCF plan
• Verified data gathered from PCMF is being used to actively update the clinical evaluation (as well as the risk management system)

Notified Bodies will now also:

• Considered whether data obtained from PMCF should be submitted to the Notified Body between scheduled assessment activities
• Considered an appropriate period for certification of the product in order to set a particular time point at which PMCF data will be assessed by the Notified Body.

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