Overview
This SOP outlines the process for carrying out Post-Market Surveillance (PMS) for products. It ensures the proactive collection of new safety and performance information, which is then used to support risk management, clinical evaluation, and software development processes for our products.
| Process Owner | \ |
| Key Performance Indicators | \ |
Regulatory References:
| EU Regulation 2017/745 | Art. 83 – 86 (Post-market surveillance), Art. 88 (Trend reporting) |
General Considerations
Each product is managed individually, necessitating the creation and continuous updating of a Post-Market Surveillance Plan and a Post-Market Surveillance Report (for class I devices) or a Periodic Safety Update Report (for class IIa and higher).
Note: For class I devices, consider extending the update interval (e.g., every two or three years).
Note: Assigning this responsibility to a different role is allowed; it should be someone with expertise in both product development and clinical matters.
Process Steps
1. Develop the Post-Market Surveillance Plan
A new Post-Market Surveillance Plan must be developed for each product, based on clinical evaluations and technical documentation.
For class IIa devices, the post-market surveillance cycle should not exceed two years. For classes IIb and III, annual surveillance cycles are mandatory. Each cycle for class IIa and higher devices concludes with a Periodic Safety Update Report (PSUR). Class I devices may have longer intervals between reviews and will require a Post-Market Surveillance Report that should be updated whenever new relevant data emerges.
The Post-Market Surveillance Plan should be created using the Post-Market Surveillance Plan Template, aligning with MDR Annex III, Section 1.
| Participants | QMO, Product Manager |
| Input | Device Description Clinical Evaluation Risk Management Report |
| Output | Post-Market Surveillance Plan |
2. Gather Information and Take Action
PMS is conducted as outlined in the Post-Market Surveillance Plan according to the specified timeline.
Responsible personnel continuously gather information across various categories and record it in the report template. The following categories must be considered:
- Clinical evaluations and PMCF activities: Input from Post-Market Clinical Follow-Up activities (refer to the clinical evaluation process and PMCF plan template).
- New market research and technology: Information on similar devices and emerging technologies.
- Recall and incident reports: Data on recalls, incidents, and adverse side effects from competitors, similar products, or our own devices (e.g., consult BfArM / FDA databases as specified in the PMS plan; see the vigilance process).
- Updated norms, standards, directives, regulations, and laws: Verification of the currency of the applicable regulation list.
- SOUP (Software of Unknown Provenance): Ensuring the SOUP list is current.
- Customer complaints: Feedback from customers and complaints (refer to feedback management process).
- Additional feedback: Information from sales, marketing, distributors, and other parties.
Each piece of information is evaluated for its relevance to the company’s products and rated based on its potential impact on safety and performance:
- Severe: Serious injury or death
- Moderate: Non-serious injury
- Marginal: All other cases
Appropriate actions are taken based on the relevance, severity, and statistical significance of the data. The QMO and the Person Responsible for Regulatory Compliance (PRRC) must be consulted, and other roles (e.g., medical staff) involved as needed.
Potential actions include:
- Updating the risk management file: Adding new risks, revising existing assumptions, or updating mitigation measures.
- Initiating CAPA: Updating processes, training, or resource allocation. CAPAs based on PMS data should be reported to the competent authority and/or Notified Body.
- Vigilance reporting: For serious incidents or FSCA, notify the competent authority.
- Product design changes: Following the change management and software development procedures.
| Participants | QMO, Product Manager |
| Input | Post-Market Surveillance Plan Post-Market Surveillance Information |
| Output | Evaluated Information |
3. Perform Trend Analysis
All collected PMS data must be assessed against the risk management file. If there is a significant increase in the occurrence or severity of non-serious incidents or undesirable side effects, it must be reported to the competent authority as outlined in the Vigilance SOP, provided:
- The increase could negatively affect the device’s benefit-risk profile (see Annex I, Para. 1 + 5 MDR).
- The increase could lead to unacceptable risks for patients, users, or others when compared to intended benefits.
Significant increases are determined based on frequency and severity assumptions defined in the device’s risk management file. Records of the trend analysis must be stored with the device’s TechDoc records.
| Participants | QMO |
| Input | Collected information |
| Output | Conducted trend analysis Reported significant trends to the competent authority (if necessary) |
4. Create the Post-Market Surveillance Report (PMSR)
For class I devices, the Product Manager completes the PMSR, which must be reviewed by the PRRC. The report should include:
- Main findings and analysis from PMS activities during the review period as outlined in the PMS Plan.
- Description and rationale for any preventive and corrective measures taken.
| Participants | QMO, Product Manager |
| Input | Collected and evaluated information |
| Output | Post-Market Surveillance Report |
5. Create the Periodic Safety Update Report (PSUR)
For class IIa and higher devices, the Product Manager compiles the PSUR, reviewed by the PRRC. The report should include:
- Key findings from PMS activities during the surveillance period as outlined in the PMS Plan.
- Rationale and details of any preventive and corrective measures implemented.
- Conclusions regarding risk management and clinical evaluation, including overall residual risk and benefit-risk assessment.
- PMCF findings.
- Sales volume data, user numbers, and, where possible, device usage frequency.
| Participants | QMO, Product Manager |
| Input | Collected and evaluated information |
| Output | Periodic Safety Update Report |