Post Market Clinical Follow (PMCF) up is an effective method that constantly helps to monitor the clinical evaluation results. This assessment and examination of clinical information relating to the medical device confirm the clinical security and execution of the device when utilized as by the intended manufacturer.
A study was done following the CE checking of a device and proposed to address explicit questions identifying with clinical safety or the performance that is the lingering dangers of a device when utilized as per its affirmed marking. The goal is to confirm that the clinical performance and safety all through the device lifetime, the adequacy of distinguished dangers and to recognize developing dangers, based on real-time data collection.
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PMCF activities range from an extensive examination of information through existing device enrollments to conducting another new clinical investigation. European and American administrative prerequisites guidance the medical devices makers to consider the Post advertise clinical follow up as a feature of their Post Market Surveillance (PMS) Plan. Since clinical information accumulated in the pre-advertise stage might be too constrained to even consider identifying uncommon occasions or episodes. Post Market Clinical Follow-up is critical to recognize new and obscure risks and to encompass foreseen residual risks.
Furthermore, according to the MEDDEV 2.12 – 2 rev 2 each Post Market Clinical Follow up study must have a clinical investigation/PMCF plan describing about the design and methodologies of the planned study.
Circumstances, where a Post Market Clinical Follow up study, is indicated:
- Innovation or critical changes to the product
- High product-related hazard
- The severity of infection/treatment challenges
- Results from any past clinical examination
- Risks distinguished from the writing
- Unanswered inquiries of long – term security and execution
- Continued approval in instances of disparity
- Interaction with other medicinal products or treatment.
Post Market Clinical Follow – up Objectives
To meet MDR requirements, medical device manufacturers should design and run Post Market Clinical Follow up studies with main objectives:
- Confirming the device safety and its clinical performance
- Ensuring about continued acceptability of identified risks
- Detecting emerging risks on the basis of factual proofs
Post Market Clinical Follow – Up Design
- The extended follow-up of patients enrolled in premarket inspections
- A new clinical investigation
- A review of information obtained from a device registry;
- A review of related retrospective information from patients previously exposed to the device
Post Market Clinical Follow up studies must be outlined as a well – designed clinical investigation/Post Market Clinical Follow up Plan including:
- Clearly expressed research questions, targets and related endpoint
- Scientifically solid structure with a fitting basis and factual analysis plan
- A plan for conduct as per the suitable standard
- A plan for the inspection of the information and for making suitable determination.
EU MDR Requirements:
Post Market Clinical follows up ought to be performed in accordance with a documented technique set down in Post Market Clinical Follow up plan.
The manufacturer will analyze the discoveries of the Post Market Clinical Follow up and document the outcomes in a Post Market Clinical Follow up evaluation report.
Post Market Clinical Follow up plan must include some methods aiming of:
- Confirming about the security and execution of the device all through its normal lifetime.
- Identifying beforehand unknown side – impacts and look at about the recognized side – impacts and contraindications.
- Identifying and examining risks based on factual proof.
- Ensuring the continued with the acceptability of the risk-benefit ratio.
The role of the Notified Body in Post Market Clinical Follow up
- Review the suitability of the producer\’s general posts – market surveillance plans
- Verify that Post Market Clinical follow up as a feature of the general clinical evaluation is directed by or on the behalf of the manufacturer by properly skilled assessors.
- Verify that the manufacturer has properly considered the need for Post Market Clinical Follow up as a feature of post-market surveillance dependent on the lingering risks including those is recognized from the results of the clinical evaluation and from the characteristics of the medical devices.
- Verify that Post Market Clinical Follow up is directed when the clinical evaluation is based only on clinical information from comparable devices for beginning similarity appraisal and that Post Market Clinical Follow up addresses the remaining dangers recognized for the equivalent devices.
- Assess the suitability of any justification exhibited by a manufacturer for not directing a particular Post Market Clinical Follow up design as a component of Post Market Surveillance.
- Assess the appropriateness of the proposed Post Market Clinical Follow up plan in showing the manufacturers stated objectives and addressing the lingering risks
- Verify that data assembled by the manufacturer from Post Market Clinical Follow up whether good or negative is being utilized to effectively update the clinical evaluation
- Consider whether, in view of the particular device evaluation, information acquired from Post Market Clinical Follow up ought to be transmitted to the Notified Body between planned assessment activities (ex. reconnaissance review, recertification assessment)
- Consider a proper period for certification of the product.
The information and conclusion obtained from the Post Market Clinical Follow up study are utilized to impart clinical data to the clinical evaluation process. This may bring about the need to reassess whether the device keeps on following the necessary requirements. Such assessment may bring about restorative or preventive activities, for example, changes to the labelling/directions for use, changes to manufacturing procedures, and changes to the device structure, or public health warnings. Effectual Post Market Clinical Follow Up study is a prerequisite requirement for CE marking Detailed and sufficient Post Market Clinical Follow up Plan is vital during CE audits. Clear and precise linkage to Risk Management, Clinical Evaluation and Post Market Clinical Follow Up must be built up. The requirement for Post Market Clinical Follows Up emerges when medical devices are accessed through their identical nature and in instances of devices where recognizable clinical data of conceivable emerging risks and long – term safety assessment and execution stay primary.
