Post-Market Clinical Follow-up (PMCF)
In the context of the Medical Device Regulation (MDR), PMCF (Post-Market Clinical Follow-up) activities are activities that are conducted after a medical device has been placed on the market. These activities are designed to assess the continued safety and performance of the device in real-world clinical settings, and they are typically conducted by the manufacturer of the medical device. PMCF activities may include collecting data on the device’s performance and safety from a large number of patients, as well as analyzing this data to identify any potential risks or hazards associated with the device. The results of these activities are used to inform the regulatory decision-making process, and they are also used by healthcare providers to determine the appropriate use and potential benefits of the medical device. Overall, PMCF activities are an important part of the regulatory process for medical devices, and they play a crucial role in ensuring the continued safety and effectiveness of these devices for patients.
How Escentia can help you with your PMCF
To ensure the safety and performance of your products, we support you in proactively collecting clinical data as required by the MDR.
Our comprehensive range of services include:
- Planning PMCF activities based on MDCG 2020-7
- Designing and managing user surveys: get the answers you need to your development and marketing questions while fulfilling regulatory requirements. We provide our clients with regular updates as well as an actionable final report
- Running regular database reviews and including any additional data
- Providing PMCF reports with updated risk/benefit analysis
In this way, the clinic evaluation can be updated on a regular basis with the collected data as a continuous process to meet all the requirements of Regulation (EU) 2017/745.
