- The PMS system must be documented and implemented within the manufacturers’ QMS. The PMS should be risk-based according to the products manufactured.
- The PMS system must be suitable to gather, record and analyse the relevant data. It should be done in accordance with the control strategy of the manufactured product to gather relevant data regarding the quality. In cases of negative signals, the CAPA process might be started.
- a) The feedback gathered on a product, can be assessed by its occurence over time, whether it exceeds the initially set occurence levels in the specific risk management file. If exceeding, actions should be taken.
b) With the assessment of a potential impact on usability, design and manufacturing, the specific risk assessment might be updated and thus, the outcomes of risk mitigation, including the communication of risks.
c) With the update of risk assessments and gathering of feedback from the market, the clinical evaluation report (CER) might be updated as well.
d) With every treatment, the number of patients for a safety and clinical performance evaluation increases, and thus, the summary might be updated as well.
e) Depending on the feedback and the occurence rates, CAPA or field actions might be started.
f) With every upate of the risk management triggered by feedback, the risk mitigation might be updated as well potentially leading to an optimization of the usability, design or manufacturing of the product.
g) Market data of similar products or sub-assemblies might support the informed decision making and might leverage knowledge from other products for the one in question.
h) Trending of data is relevant for early detection of potentially safety or performance relevant signals. The technical documentation shall be updated accordingly.
- If a need for preventive or corrective action or both is identified, the manufacturer shall implement the appropriate measures and inform the competent authorities concerned and, where applicable, the notified body. Where a serious incident is identified or a field safety corrective action is implemented, it shall be reported.