MDR Requirements for Post Market Surveillance

Post-market surveillance (PMS) refers to a framework the regulates manufacturers of medical devices post-market. Medical Device Regulation lays special emphasis regarding clinical data and safety-related data. The performance of CE-marked products is monitored closely to make it easier to identify any risks related to the practical use of the products.

What Is the Difference Between Vigilance and Post-Market Surveillance?

Vigilance refers to field safety corrective actions, reporting incidents, and recalls. It is only a part of post-market surveillance, which is more of a reactive system than a proactive one. As per the MDR, vigilance is what defines the incidents that manufacturers should report to relevant authorities. The manufacturers are also required to analyze their vigilance data.

What Are the PMS Obligations for Manufacturers?

All the manufacturers are required to establish and maintain a PMS process, which should be proportionate to the type of device and class of risk. PMS is thus a requirement irrespective of the medical device classification. The requirement details are what may differ. The manufacturers are also required to base their PMS systems on a PMS plan. A PMS plan is considered one of the technical documents that prove a manufacturer is compliant with the MDR requirements for PMS.

What Is a PMS Report?

Manufacturers of medical devices ranked class I prepare the PMS report. It summarizes the findings of all data gathered per the PMS plan. The report usually includes the description of both preventive and corrective measures taken, which have to be updated whenever necessary.

What Is a PMCF?

Post-market clinical follow-up (PMCF)refers to a systematic collection of clinical data, which is then used to answer vital questions regarding the performance and safety of the medical device. The data also helps with updating clinical evaluations. The CER has to include the PMS data and info in the post-market section.

Which Kind of Data Should Be Collected?

PMCF can include data collected from complaints, the vigilance system, technical information, and information that is available publicly. According to the MDR, the procedures and methods of collecting relevant data include gathering gained clinical experience, screening of scientific literature, and feedback from users.