MDR - Chapter VII - article 83

Original text

Expert opinion

Post-market surveillance system of the manufacturer

1. For each device, manufacturers shall plan, establish, document, implement, maintain and update a post-market surveillance system in a manner that is proportionate to the risk class and appropriate for the type of device. That system shall be an integral part of the manufacturer’s quality management system referred to in Article 10(9).

PMS system of the manufacturer

The PMS system must be documented and implemented within the manufacturers’ QMS. The PMS should be risk-based according to the products manufactured.
As there is limited guidance on how to set up such a PMS system, ISO TR 20416 has been created.

2. The post-market surveillance system shall be suited to actively and systematically gathering, recording and analysing relevant data on the quality, performance and safety of a device throughout its entire lifetime, and to drawing the necessary conclusions and to determining, implementing and monitoring any preventive and corrective actions.


The PMS system must be suitable to gather, record and analyse the relevant data. This is usually done in accordance with the control strategy of the manufactured product to gather relevant data regarding the quality. The feedback gathered on a product is triaged, as best practice, to whether it qualifies as a complaint and in a second step, whether it belongs to either usability, design or manufacturing. From that triage and together with the risk management file, performance- or safety-relevant conclusions can be drawn. In cases of negative signals, the CAPA process might be started.

3. Data gathered by the manufacturer’s post-market surveillance system shall in particular be used:

(a) to update the benefit-risk determination and to improve the risk management as referred to in Chapter I of Annex I;

(b) to update the design and manufacturing information, the instructions for use and the labelling;

(c) to update the clinical evaluation;

(d) to update the summary of safety and clinical performance referred to in Article 32;

(e) for the identification of needs for preventive, corrective or field safety corrective action;

(f) for the identification of options to improve the usability, performance and safety of the device;

(g) when relevant, to contribute to the post-market surveillance of other devices; and

(h) to detect and report trends in accordance with Article 88. The technical documentation shall be updated accordingly.

a) The feedback gathered on a product, as a best practice, 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 and the benefit-risk determination might be updated.

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. Specifically, if new hazards are detected with an impact on the clinical safety.

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.

4. If, in the course of the post-market surveillance, 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 in accordance with Article 87

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