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Templates ISO 13485 Templates

Updated August 31, 2023

Template: SOP Post-Market Surveillance

Sven Piechottka

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This Template Has Been Audited!

This template or a slightly changed version of it has gone through the following audits successfully:

Berlin Competent Authority (LaGeSo), 06/2022

Berlin Competent Authority (LaGeSo), 07/2023

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Related Records

The following templates are records of this template. That means that this document mentions them somewhere and you need to fill them out to actually implement whatever this document proposes.

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Berlin Competent Authority (LaGeSo), 06/2022

Berlin Competent Authority (LaGeSo), 07/2023

SOP Post-Market Surveillance


This SOP describes how Post-Market Surveillance is performed for products. It ensures that new information about safety and performance is proactively collected and can be used as input for the risk management, clinical evaluation and software development of our products.

Process Owner <enter role of process owner>
Key Performance Indicators <enter KPIs to be tracked for the Management Review>

Regulatory References:

EU Regulation 2017/745 Art. 83 - 86 (Post-market surveillance), Art. 88 (Trend reporting)

General Considerations

This process is followed for each product separately, meaning that for each product, a Post-Market Surveillance Plan and Post-Market Surveillance Report (class I) or Periodic Safety Update Report (class IIa and higher) are created and continuously updated.

Note: For class I devices, you could specify a longer update interval, e.g. once every two or three years.

Note: Feel free to assign the responsibility to any other role. It typically makes sense to choose a role that is both close to product development as well as clinical issues.

Process Steps

1. Create Post-Market Surveillance Plan

Based on the clinical evaluation and technical documentation, a new Post-Market Surveillance Plan is created for a product.

For medical devices of class IIa, post-market surveillance cycles may extend to no longer than two years. For medical devices of classes IIb and III, annual surveillance cycles apply. For devices of class IIa and higher, each surveillance cycle is concluded with the compilation of a periodic safety update report (see below). For class I devices, longer surveillance cycles may be defined and a Post-Market Surveillance Report is compiled. At least, this report should be updated when new relevant data has been identified.

The plan should be created based on the Post-Market Surveillance Plan Template, following MDR Annex III, Section 1.

Participants QMO,
Product Manager
Input Device Description
Clinical Evaluation
Risk Management Report
Output Post-Market Surveillance Plan

2. Collect Information and Initiate Actions

The Post-Market Surveillance is carried out as described in the Post-Market Surveillance Plan in the defined interval.

The responsible employees continuously collect information from all the categories described below and enter them into the report template. At minimum, the following information categories have to be taken into consideration:

For each part of information, it is assessed whether it is applicable to the company’s product. Additionally, the severity of impact on device safety and performance is rated on the following scale:

Depending on the applicability, severity and statistical relevance of the new information, appropriate actions are initiated. The QMO and the Person Responsible for Regulatory Compliance (PRRC) must be consulted in this step, other roles (e.g. medical staff) should be involved if needed.

Actions may entail:

Participants QMO,
Product Manager
Input Post-Market Surveillance Plan
Post-Market Surveillance Information
Output Evaluated Information

3. Conduct Trend Analysis

All collected post-market surveillance information must be reviewed against the device’s risk management file. Any statistically significant increase in the frequency or severity of non-serious incidents and expected undesirable side effects must reported to the competent authority following the SOP Vigilance, if:

The significant increase is established in comparison to the assumptions for frequency or severity of such incidents during the product lifetime, which are specified in the device’s risk management file. Records of the conducted trend analysis shall be stored with other TechDoc records of the device.

Participants QMO
Input Collected information
Output Conducted trend analysis
Reported statistically significant trend to competent authority (if necessary)

4. Compile Post-Market Surveillance Report (PMSR)

For class I devices, the Product Manager finalizes the Post-Market Surveillance Report (PMSR), which is at least reviewed by the Person Responsible for Regulatory Compliance (PRRC). The report should contain at least the following information:

Participants QMO,
Product Manager
Input Collected and evaluated information
Output Post-Market Surveillance Report

5. Compile Periodic Safety Update Report (PSUR)

For class IIa devices and higher, the Product Manager finalizes the Periodic Safety Update Report (PSUR), which is at least reviewed by the Person Responsible for Regulatory Compliance (PRRC). The report should contain at least the following information:

Participants QMO,
Product Manager
Input Collected and evaluated information
Output Periodic Safety Update Report

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