Post Market Surveillance Plan
A Post Market Surveillance Plan comprises a systematic approach to continuously monitor the safety and performance of medical devices available in the market. It entails a well-defined strategy for gathering data directly related to the risks associated with the medical device’s intended use.
The significance of the Post Market Surveillance Plan lies in its ability to outline the requirements for conducting PMS activities. This plan is mandatory for all devices, excluding custom-made ones, and should be included in the Technical Documentation. It encompasses various aspects, such as:
- Gathering and utilizing information on serious incidents, including data from PSURs (Periodic Safety Update Reports) and field safety corrective actions.
- Maintaining records of non-serious incidents and data on any undesirable side effects.
- Incorporating information obtained from trend reporting.
- Referring to relevant specialist or technical literature, databases, and registers.
- Including particulars such as user, distributor, and importer feedback and complaints.
- Utilizing publicly available details about similar medical devices.
Suppose you’re interested in obtaining a Post Market Surveillance Plan. In that case, we offer PMS Plan Templates and Standard Operating Procedures (SOP) that comply with EN ISO 13485:2016, Section 8.2.1, and the Meddev NB-MED/2.12/Rec.1 guideline. These templates will assist you in preparing the Medical Device CE Marking and MDR Technical File, with the PMS Procedure/SOP, Plan, and Report, along with its conclusion, forming an integral part of the process.
To effectively conduct PMS planning, the following steps are recommended:
- Implement a proactive and systematic process for collecting information.
- Utilize effective and appropriate methods to assess the collected data.
- Establish suitable measures and threshold values to continuously reevaluate the benefit-risk analysis and risk management.
- Employ effective methods and tools to examine complaints and analyze field experience related to the market.
- Develop protocols to address events subject to trend reports.
- Establish protocols for effective interaction with competent authorities, notified bodies, economic operators, and users.
- Refer to procedures that fulfil the manufacturer’s obligations for the PMS system, PMS plan, and Periodic Safety Update Report.
- Implement systematic procedures to identify and initiate appropriate measures, including corrective actions.
- Utilize effective tools for detecting and identifying devices that may require corrective actions.
- Develop a Post-Market Clinical Follow-up (PMCF) Plan according to Annex III of the MDR or justify if a PMCF is not applicable.