Post Marketing Surveillance
Post Market Clinical Follow-Up

English

Post Marketing Surveillance

The Labcor Post Marketing Surveillance (PMS) was composed by Literature search and review of equivalent product, and by Post-Market Clinical Follow-up.

Post-Market Clinical Follow-up

The Labcor Post-Market Clinical Follow-up (PMCF) was designed according to MEDDEV 2.12/2 rev. 2 (January 2012) and Council Directive 93/42/EEC (June 1993). According to MEDDEV 2.12/2 a precondition for placing a product on the market is that conformity to the relevant Essential Requirements, including a favorable benefit/risk ratio, has been demonstrated. As part of the manufacturer’s quality system, an appropriate post-market surveillance plan is key to identifying and investigating residual risks associated with the use of medical devices placed on the market. These residual risks should be investigated and assessed in the post-market phase through systematic PMCF study(ies). In accordance to Directive 93/42, the manufacturer must notify the competent authorities of: (i) any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labeling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health; (ii) any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in subparagraph (i) leading to systematic recall of devices of the same type by the manufacturer. The PMCF objective is to confirm clinical performance and safety throughout the expected lifetime of the medical device, the acceptability of identified risks and to detect emerging risks on the basis of factual evidence. The Labcor PMCF has the objective of identifying and investigating residual risks associated with the use of Labcor products, collecting implant data and adverse event. The “Implant data” form must be collected by the distributor and/or sales representative as soon as possible after the surgery. All product implant must be reported to inform the model, serial number, surgeon and date of implant. The “Event Adverse report” form is available for report any adverse event or death that can occur follow the implantation, these information can be completed by surgeon, physician, distributor and/or sales representative. All data is confidential, only will be accessed by Labcor clinical follow-up department and Notified Body. Patient identification is confidential. The “Implant data” and “Event Adverse report” forms are available on the righ side menu of this page.


Forms