Medical device and MedTech manufacturers are required to perform a clinical evaluation to earn their initial CE marking, and to maintain these documents as per the MDR. The EU MDR defines clinical evaluation as "a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer.
These documents will include the literature search and other evaluation criteria which will be used to perform the clinical evaluation, the results of which are documented in the CER.
The CER documents the results of the CEP, with a large focus on reviewing literature and clinical investigations. Post market data is also reviewed as part of this report.
Post-market clinical follow-up is a type of post-market surveillance that utilizes a proactive approach. The clinical evaluation will determine whether a PMCF is required; not every medical device requires one. The EU MDR defines PMCF to be "understood to be a continuous process that updates the clinical evaluation."
PMCF Plans outline the intended strategy for collecting clinical data on a medical device that is - or once it is - on the market. It includes details such as the objectives, methods, study design, data analysis, timelines, responsibilities, and resources required for conducting PMCF activities, which can be general or specific.
The PMCF Report summarizes the results of the planned activities part of the PMCF Plan and evaluates the device's/technology's continued safety and performance in real-world clinical use. This report is updated, at a minimum, on a predetermined cadence, and deviations from the PMCF Plan are noted.
Post-market surveillance is a systematic process to collect and review data on the safety and performance of a medical device on the market. This information gathered, per the EU MDR, is used to review several items, including the benefit/risk profile, manufacturing information, IFUs, clinical evaluation, summary of safety and performance, technical documentation, corrective or preventive actions, and more.
The PMS Plan outlines the strategy for systematically collecting and monitoring data on the safety and performance of a medical device on the market. At times, the PMS Plan can include a PMCF Plan, though the PMCF Plan is often a standalone document referenced as part of the PMS system.
Interested in boosting your organization's awareness of public information about your device? We create a monthly report of publicly available data for your device using various sources, including adverse event reporting databases (FDA MAUDE, TPLC, Health Canada Reporting, SwissMedic, MHRA Reporting, etc.), literature (Embase. PubMed), and recalls (ECRI).
We customize our strategy for your device, the level of desired reporting, and the regions where it is sold.
PMSRs and PSURs, required by the EU MDR, are largely written in the same manner, with a focus on the conclusions of the benefit-risk determination, the main findings of the PMCF, the volume of sales, and an estimated evaluation of the size and other characteristics of the population using the device. Class I devices require a PMSR, while all other risk classes require a PSUR.
Ask our CE and PMS experts about CE and PMS compliance and requirements for your technology.
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..and let us handle your ongoing Post-Market Surveillance. See how your device (and similar devices) are operating out in the market!