먼저 용어의 뜻은 아래와 같습니다. (MDR Chapter 1, Article 2 'Definitions' 참조, Vigilance 는 없음)
 

'post-market surveillance’ means all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions;

Chapter VII POST-MARKET SURVEILLANCE, VIGILANCE AND MARKET SURVEILLANCE 내 SECTION 1 Post-market surveillance 에서 확인할 수 있으며, SECTION 2 는 Vigilance 입니다.

PMS Section 는 아래와 같이 4가지 Article 로 구성되어 있습니다.

• Post-market surveillance system of the manufacturer
• Post-market surveillance plan
• Post-market surveillance report
• Periodic safety update report

제조자는 각 제품마다 위험등급과 제품의 형식에 따라 적절한 방법으로 PMS 시스템을 계획, 수립, 문서화, 시행, 유지 및 업데이트를 해야 합니다. 또한 이 스템은 Article 10(9)에서의 제조자의 품질관리시스템의 필수적인 부분이 되어야 합니다.

또한 설정된 PMS plan은 Article III의 Section 1.1 (Technical documentation on post-marktet surveillance)의 요구사항에 따라야 합니다.

ANNEX III – TECHNICAL DOCUMENTATION ON POST-MARKET SURVEILLANCE  에 따라
Post-market surveillance plan 은 아래와 같이 계획되어야 합니다.

1.        PMS Plan은 유용한 정보의 수집 및 활용이 다루어져야 한다.
2. information concerning serious incidents, including information from PSURs, and field safety corrective actions;
3. report records referring to non-serious incidents and data on any undesirable side-effects;
4. Periodic safety update report information from trend reporting;
5.        relevant special ist or technical literature, databases and/or registers; 
6.        information, including feedbacks and complaints, provided by users, distributors and importers; and
7.        publicly available information about similar medical devices.

2. PMS plan은 최소한 다음 사항을 포함하여야 한다.
3.        a proactive and systematic process to collect any information referred to in point (a). The process shall allow a correct characterisation of the performance of the devices and shall also allow a comparison to be made between the device and similar products available on the market;
4.        effective and appropriate methods and processes to assess the collected data;
5.        suitable indicators and threshold values that shall be used in the continuous reassessment of the benefit- risk analysis and of the risk management as referred to in Section 3 of Annex I;
6.        effective and appropriate methods and tools to investigate complaints and analyse market-related experience collected in the field;
7.        methods and protocols to manage the events subject to the trend report as provided for in Article 88, including the methods and protocols to be used to establish any statistically significant increase in the frequency or severity of incidents as well as the observation period;
8.        methods and protocols to communicate effectively with competent authorities, notified bodies, economic operators and users;
9.        reference to procedures to fulfil the manufacturers obligations laid down in Articles 83, 84 and 86;
10.        systematic procedures to identify and initiate appropriate measures including corrective actions;
11.        effective tools to trace and identify devices for which corrective actions might be necessary; and
12.        a PMCF plan as referred to in Part B of Annex XIV, or a justification as to why a PMCF is not applicable.