PMCF: Monitoring under Everyday Conditions with Post Market Clinical Follow Up.
An essential and mandatory part of quality management is the post-marketing follow-up of each medical device. A system or clinical follow-up plan must be established and maintained to enable post-market surveillance (PMS).
Since it is often not possible to exclude all risks during the approval process, post-market monitoring under everyday conditions is essential.
Data sources for this monitoring include post-market clinical follow-up (PMCF), internal vigilance systems, and external database searches.
When PMCF studies become necessary
Post-market clinical follow-up studies become necessary as soon as a regular market observation does not provide sufficient clinical data, which are required for the mandatory document updates.
The data generated in the Post-Market Clinical Follow Up studies complement the existing clinical data and are thus a subset of the PMS. For example, PMCF studies may be necessary for novel or high-risk products.
These studies proceed according to a predefined Post Market Clinical Follow Up Plan (PMCF Plan). In addition to the observation and evaluation of one’s own product, evaluations of similar products are used to draw conclusions about one’s own product. The PMCF Plan is a component of the Post Market Surveillance Plan (PMS Plan).
Medicoforum, together with CRO and sister company Mediconomics, is an expert in conducting PMCF studies.
The European Medical Devices Regulation (Article 61 Clinical Evaluation, Annex XIV MDR) requires proactive, continuous, objective and thorough documentation and clinical evaluation. The documentation and clinical data generated by the clinical follow-up plan must be updated throughout the life cycle of the medical device.
In this process, corresponding data on quality, safety, usability, justifiability of the risk-benefit ratio and performance are collected in order to identify necessary corrective measures and thus to be able to set appropriate interventions. Furthermore, the MDR requires regular reporting of PMS results and measures in the form of “safety reports.”
Determination of the scope according to the type of product
The scope and extent of this assessment is closely linked to the classification, intended use, nature and risks of the product in question. For some products, clinical monitoring may not be considered necessary with appropriate justification and documentation.
Post-market clinical follow-up activities should not only identify unknown side effects and contraindications at an early stage, but also systematically identify incorrect or off-label uses of the product and possibly trigger a re-evaluation of its intended purpose. Safety corrective actions and incidents must be reported to the authorities and investigated promptly.
How Medicoforum supports you
Our team of experts supports you as a manufacturer with all PMCF obligations and activities such as development of a PMS plan, PMCF Plan or the execution of your Post Market Clinical Follow Up – saving you time and unnecessary bureaucracy.