Post-Market Clinical Follow-up (PMCF) is an essential component of Post-Market Surveillance applying to almost all medical devices under the New Medical Device Regulation. According to MDR, PMCF is a continuous process that updates the clinical evaluation of a specific device. It is expected to consist of a proactive collection and evaluation of clinical data from the use in or on humans of a device which bears the CE marking and is placed on the market or put into service within its intended purpose.
The aims of PMCF are to confirm the safety and performance of the device throughout its expected lifetime, identify previously unknown side-effects and monitor the identified side-effects and contraindications, identify and analyse emergent risks on the basis of factual evidence, ensure the continued acceptability of the benefit-risk ratio and to identify possible systematic misuse or off-label use of the device, with a view to verifying that the intended purpose is correct. PMCF studies are performed on a medical device bearing CE-mark within its intended purpose as detailed in the instructions for use of the respective device.
They contribute to the risk management process of the device. PMCF studies are to be conducted according to applicable laws and regulations, ethical requirements and should follow appropriate guidance and standards such as ISO14155. The PMCF study plan includes (a) clearly stated objective(s), scientifically sound study design and statistical analysis methods.
CERC proposes cost-effective solutions to assist cardiovascular medical device manufacturers ensuring compliant PMCF according to MDR. The proposed services include, but are not limited to:
- PMCF study protocol writing,
- electronic data collection system,
- study site-set-up and follow-up,
- statistical analysis and annual reporting.
Applying centralized monitoring and risk-based source data verification guarantees high quality of collected data.
