Post-Market Clinical Follow-up (PMCF) is a process where a medical device manufacturer actively collects data on the safety and performance of a device after it has been placed on the market, with the purpose of monitoring its long-term safety and effectiveness. PMCF is crucial for ensuring continued patient safety and maintaining regulatory compliance, especially under regulations like the EU Medical Device Regulation (MDR), where ongoing monitoring of a device’s performance is mandatory.
At Harvest Healthcare, we collect post-market data through an evaluation process that involves customers providing honest feedback on the performance of our products. The evaluation form gathers information about the patient/resident and their clinical condition both before and during the use of our products. No patient identifiers are used, ensuring anonymity and full compliance with GDPR at all times.
Additionally, data is collected to assess product performance, customer satisfaction, potential risks, and possible improvements to enhance patient experience and comfort. At Harvest Healthcare, we prioritise the patient, with their satisfaction being our ultimate goal. Hearing feedback from both patients and clinicians is pivotal in achieving this, which is why we have included a section for input from both groups.
The PMCF evaluation forms are quick and simple to complete, taking no more than a few minutes. Data should be collected after at least 4–6 weeks of product use to ensure a fair performance assessment. Any data points related to the patient’s condition before using the product can be completed retrospectively using their clinical notes and care plans.
Here is the link to access the Post-Market Clinical Follow-up (PMCF)
