OpenRegulatory Template

SOP Post-Market Surveillance

Summary

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.

General Considerations

This process is followed for each product separately, meaning that for each product, a Post-Market Surveillance Plan and Report are created and continuously updated.

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

Responsibility Document Update Interval
Product Manager Once per year

Please also note that according to the Transitional Provisions of Art. 120 MDR, you are required to comply with MDR requirements regarding post-market surveillance (Art. 83 ff.) starting May 2021 even if your product runs on a valid MDD certificate. This basically means to use the new format of a ‘Period Safety Update Report’ (PSUR).

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.

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

2. Conduct Post-Market Surveillance

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 observed trends 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 Output
Post-Market Surveillance Plan Evaluated Information
Post-Market Surveillance Information

3. Compile Periodic Safety Update Report

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
PRRC
Product Manager
Input Output
Collected and evaluated information Periodic Safety Update Report

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