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CSC-PR-005-Monitoring-and-Surveillance.md

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qms_version 2.2.0
sop_version 2.0.3

Post-Deployment Surveillance SOP

General
Document ID CSC PR.005
Document Version 2.0.1
Author
Approval
QMS Version 2.2.0
Regulatory References MDR Article 84

Purpose

This document describes the actions required once an application developed under this QMS has been deployed into a clinical setting, so that the performance of the medical device is continuously monitored. 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 applications.

Scope

The processes in this document must be followed for all computing projects where the solution is intended to be used within a clinical setting, directly or indirectly influences patient care, or uses patient data. It also covers projects that involve the use of machine learning algorithms.

Definitions

Acronym Definition
QMO Quality Management Officer
PMCF Post-Deployment Clinical Follow-Up activities
MHRA Medicines and Healthcare Products Regulatory Agency
SOUP Software of Unknown Provenance
CAPA Corrective and Preventive Action

Roles and Responsibilities

At the start of the project the following roles must be allocated.

Role Responsibility
Clinical Safety Officer Provide expertise and leadership in all activities associated with the evaluation of clinical risk management for the applications.
Product/process owner Takes ultimate responsibility for deployed product

1. General Considerations

This process is followed for each product separately, meaning that for each product, a Post-Deployment 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-deployment 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).

2. Process Steps

2.1 Create Post-Deployment Surveillance Plan

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

Participants
Clinical Safety Officer
Product Manager
Input Output
Device Description Post-Deployment Surveillance Plan
Clinical Evaluation
Risk Management Report

2.2 Conduct Post-Deployment Surveillance

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

Ideally, the responsible person continuously collects information of all the categories described below and enters them into our report template.

At minimum, the following information categories have to be taken into consideration:

  • Clinical evaluations and PMCF activities:: Input from our Post-Deployment Clinical Follow-Up activities.
  • New research and development in the market: Information regarding similar medical devices and technologies on the market.
  • Input from recalls and reportable events: Recalls, incidents and unintended side effects reported by competitors, similar applications and procedures or reported for other devices of our company (e.g. MHRA).
  • New or updated norms and standards, directives, regulation and other laws: Verification if the list of applicable regulations is up to date.
  • SOUP: Verification if SOUP list is up to date.
  • Complaints directly reported by customers: Information gathered through customer feedback and complaints and GitHub.
  • Trend analysis Results from trend analysis for automation bias (e.g. DICE scores for contouring automation trended over time, showing level of agreement/editing) and confirmation bias (e.g. false positive rates decreasing over time between initial prospective and 1 year audit) as well as any other trends captured.
  • Other feedback collected or reported by other stakeholders.

For each part of information, it is assessed whether it is applicable to the application. Additionally, its severity is rated on the following scale:

  • Severe: Serious injury or death
  • Moderate: Non-serious injury
  • Marginal: Everything else, less than moderate

Depending on the applicability, severity and observed trends of the new information, appropriate actions are initiated. The QMO and Medical Device Safety Officer must be consulted in this step, other roles (e.g. medical staff) should be involved if needed.

Actions may entail:

  • Updating the application risk management file, for example by adding new risks according to our risk management process, updating occurrence / severity assumptions made for risks we already documented or updating risk mitigation measures in place.
  • Initiating a CAPA, for example to update processes, training measures or resource allocation.
  • Initiating incident reporting to authorities or a application recall.
  • Design changes to the application following the change management process described in the Design and Development SOP.
Participants
Clinical Safety Officer
Product Manager
Input Output
Post-Deployment Surveillance Plan Evaluated Information
Post-Deployment Surveillance Information

2.3 Compile Periodic Safety Update Report

The Product Manager finalizes the Periodic Safety Update Report (PSUR), which is at least reviewed by the QMO. The report should contain at least the following information:

  • main findings of post-deployment surveillance activities throughout the surveillance interval
  • conclusion regarding implications for the risk management and clinical evaluation of the product, in particular the overall residual risk and benefit-risk determination
  • the usage metrics of the device, e.g. amount of users and, where practicable, the usage frequency of the device.
Participants
Quality Management Officer
Clinical Safety Officer
Product Manager
Input Output
Collected and evaluated information Periodic Safety Update Report

Template Copyright openregulatory.com. See template license.