This plan outlines product-specific post-market surveillance activities. The general procedures for conducting post-market surveillance are described in the SOP Post-Market Surveillance, with outputs documented in the Post-Market Surveillance Report or the Periodic Safety Update Report.
Regulatory References:
| EU Regulation 2017/745 (MDR) | Art. 84 and Annex III, Para. 1.1 |
Product
| Product Name | Version | Surveillance Period |
|---|---|---|
| \ |
\<version> | \<e.g. 10/2020-10/2021> |
1. General Considerations
Note: Ensure that all post-market surveillance activities defined for your product address, at a minimum, the actions required by the MDR, as outlined in section 2 below.
As specified in Annex III, Section 1.1(b) of the MDR, the post-market surveillance plan must include:
| MDR Requirement | Activity |
|---|---|
| A proactive and systematic process to collect the information outlined in point (a). This process must allow for a proper characterization of the device’s performance and comparisons with similar products on the market. | SOP Post-Market Surveillance |
| Effective and appropriate methods to evaluate the collected data. | SOP Post-Market Surveillance |
| Suitable indicators and threshold values for ongoing reassessment of the benefit-risk analysis and risk management as referenced in Section 3 of Annex I. | PMS Plan – Trend Identification & Reporting |
| Methods and tools to investigate complaints and analyze market-related experiences gathered from the field. | SOP Feedback Management |
| Protocols for managing events requiring trend reports, including methods for identifying statistically significant increases in frequency or severity of incidents, along with the observation period. | PMS Plan – Trend Identification & Reporting |
| Methods to effectively communicate with competent authorities, notified bodies, economic operators, and users. | SOP Vigilance |
| References to procedures for fulfilling manufacturers’ obligations under Articles 83, 84, and 86. | SOP Post-Market Surveillance |
| Systematic procedures to identify and initiate appropriate actions, including corrective actions. | SOP CAPA |
| Tools to trace and identify devices that may require corrective actions. | SOP Product Certification and Registration |
| A PMCF plan as detailed in Part B of Annex XIV, or a justification if PMCF is deemed not applicable. | SOP Clinical Evaluation |
2. Data Collection Activities
| PMS Activity | Responsibility | When? | Documented in |
|---|---|---|---|
| Incident documentation and analysis of undesirable side effects | QMO | Annually | PMS Report / PSUR |
| Assess feedback (customer complaints, sales feedback). | Head of Product | Annually | PMS Report / PSUR |
| Review SOUP for newly published issues. | Head of Software Development | Biannually | PMS Report / PSUR |
| Research data on similar products in the market. | QMO | Annually | PMS Report / PSUR |
| Conduct planned post-market clinical follow-up activities. | Head of Medical Team | Annually | PMCF Evaluation Report / CER |
| Research scientific publications. | Head of Product | Annually | PMCF Evaluation Report / CER |
| Monitor updates to standards and legislation. | QMO | Annually | PMS Report / PSUR |
| Analyze trends, decide on necessary measures, and implement them. | QMO | Annually | PMS Report / PSUR |
| Update risk management files. | QMO | Annually | Risk Management Report / PMS Report / PSUR |
| Compile a post-market clinical follow-up report. | Head of Medical Team | Annually | PMCF Evaluation Report / CER |
| Compile Periodic Safety Update Report. | Head of Product | Annually | PMCF Evaluation Report / CER |
| Upload PSUR to the Eudamed database. | QMO | Annually | N/A |
| Develop post-market surveillance and PMCF plans for the next interval. | QMO | Annually | PMS & PMCF Plan |
| Document sales volume, population characteristics (e.g., profession), and device usage frequency by country. | QMO | Annually | PMS Report / PSUR |
Continues in detail under sections 3 and 4, expanding on methods, procedures, and the use of relevant databases.