T-007-001 Post-Market Surveillance (PMS) Plan
Purpose
This plan describes product-specific post-market surveillance activities to monitor the safety and performance of devices placed on the market and continuously review the benefit-risk analysis.
Scope
This PMS plan applies to: insert name of the product and its version.
Surveillance period
Insert the analysed period for the post-market surveillance activities.
Regulatory references
Insert any regulatory requirements related to the post-market surveillance plan, e.g. MDR 2017/745, Article 84 and Annex III (1.1).
Abbreviations
- PMS: Post-market surveillance
- PMCF: Post-market clinical follow up
- FSCA: Field Safety Corrective actions
- CAPA: Corrective Action Preventive Action
- PSUR: Periodic Safety Update Report
- CER: Clinical Evaluation Report
General considerations
Annex III section 1.1(b) of MDR 2017/745 describes the requirements applicable to the post-market surveillance plan.
The table below shows the regulatory requirements and how we comply with them:
| MDR requirement | Activity |
|---|---|
| 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 | |
| Effective and appropriate methods and processes to assess the collected data | |
| 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 | |
| Effective and appropriate methods and tools to investigate complaints and analyse market-related experience collected in the field | |
| 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 | |
| Methods and protocols to communicate effectively with competent authorities, notified bodies, economic operators and users | |
| Reference to procedures to fulfil the manufacturer's obligations laid down in Articles 83, 84 and 86 | |
| Systematic procedures to identify and initiate appropriate measures including corrective actions | |
| Effective tools to trace and identify devices for which corrective actions might be necessary | |
| A PMCF plan as referred to in Part B of Annex XIV, or a justification as to why a PMCF is not applicable |
Complete the table with the activities (actions) implemented to comply with the MDR requirements.
Data collection activities
The following table provides a summary of the PMS activities identified together with responsibilities, frequency of the activities and documents where the activities and their results are detailed.
| PMS activity | Responsible person | Frequency of review | Evidence |
|---|---|---|---|
| Serious incidents and Field Safety Corrective Actions (FSCA) documentation | |||
| Non-serious incidents and undesirable side-effects documentation | |||
| Customer feedback documentation | |||
| Customer complaints documentation | |||
| Research data about similar devices in the market | |||
| Research updates of standards and legislation | |||
| Analyse trends, decide on necessary measures and implement them | |||
| Clinical literature review | |||
| Research on cybersecurity and state of the art | |||
| Research on security vulnerabilities of SOUPs and software tools | |||
| Volume of sales, an estimate evaluation of the size and other characteristics of the population (such as profession) using the device and, where practicable, the usage frequency of the device, volume of sales by country | |||
| Conduct post-market clinical follow-up activities | |||
| Update risk management file | |||
| Summarise PMS activities in the PSUR | |||
| Summarise PMCF activities in the PMCF report |
Complete the table with responsibilities, and frequency of the activities and document where the results of the activities are summarised.
Serious incidents and FSCA
Complete this section with the planned activities to collect and document information about serious incidents that involved the use of the device and FSCA initiated to mitigate risks.
Non-serious incidents and side effects
Complete this section with the planned activities to collect and document information about non-serious incidents that involved the use of the device and undesirable side effects.
Customer feedback
Complete this section with the planned activities to collect and document customer feedback, such as customer surveys, and analysis of customer communications.
Customer complaints
Complete this section with the planned activities to collect and document customer complaints.
Corrective and preventive actions
Complete this section with the planned activities to collect and document corrective and preventive actions.
Data related to similar devices
Complete this section with the planned activities to collect and document information about similar devices and methodologies applied.
Regulatory requirements
Complete this section with the planned activities to collect and document information about new/revised applicable regulatory requirements.
Trend analysis
Complete this section with the planned activities and methodology to analyse trends in non-serious incidents and expected undesirable side effects.
Clinical literature
Complete this section with the planned activities and methodology to review clinical literature.
Cybersecurity and state of the art
Complete this section with the planned activities and methodology to analyse cybersecurity state of the art.
Security vulnerabilities of SOUPs and software tools
Complete this section with the planned activities to collect and document information about security vulnerabilities of SOUP used in the device and software tools used in the design and development process.
Sales data
Complete this section with the planned activities to collect and document information about the volume of sales, an estimate evaluation of the size and other characteristics of the population (such as profession) using the device and, where practicable, the usage frequency of the device, volume of sales by country.
PMCF activities
Complete this section with the planned activities to collect post-market clinical data or make reference to the document where this information is available (PMCF plan).
Planned PMS report / PSUR
Complete this section by adding the planned year and month to document all the PMS activities defined in this plan in the PMS report (for legacy devices) and the PSUR (for Legit.Health Plus).
Signature meaning
The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:
- Author: Team members involved
- Reviewer: JD-003, JD-004
- Approver: JD-001
Delete this section when you create a new record from this template.
Signature meaning
The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:
- Author: Team members involved
- Reviewer: JD-003, JD-004
- Approver: JD-001