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QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
    • GP-001 Control of documents
    • GP-002 Quality planning
    • GP-003 Audits
    • GP-004 Vigilance system
    • GP-005 Human Resources and Training
    • GP-006 Non-conformity, Corrective and Preventive actions
    • GP-007 Post-market surveillance
      • Templates
    • GP-008 Product requirements
    • GP-009 Sales
    • GP-010 Purchases and suppliers evaluation
    • GP-011 Provision of service
    • GP-012 Design, Redesign and Development
    • GP-013 Risk management
    • GP-014 Feedback and complaints
    • GP-015 Clinical evaluation
    • GP-016 Traceability and identification
    • GP-017 Technical assistance service
    • GP-018 Infrastructure and facilities
    • GP-019 Software validation plan
    • GP-020 QMS Data analysis
    • GP-021 Communications
    • GP-022 Document translation
    • GP-023 Change control management
    • GP-024 Cybersecurity
    • GP-025 Corporate Governance
    • GP-026 Product requirements for US market
    • GP-027 Product requirements for UK market
    • GP-028 Product requirements for the Brazilian market
    • GP-050 Data Protection
    • GP-051 Security violations
    • GP-052 Data Privacy Impact Assessment (DPIA)
    • GP-100 Business Continuity (BCP) and Disaster Recovery plans (DRP)
    • GP-101 Information security
    • GP-200 Remote Data Acquisition in Clinical Investigations
  • Records
  • TF_Legit.Health_Plus
  • Licenses and accreditations
  • External documentation
  • Procedures
  • GP-007 Post-market surveillance

GP-007 Post-market surveillance

Purpose​

To describe the methodology to implement a systematic procedure to actively and systematically collect, record and analyse relevant data on the quality, performance and safety of our medical device to continuously verify compliance with user and other requirements, and to provide and monitor corrective and preventive actions when required.

Scope​

The process described in this procedure applies to our medical devices.

Definitions​

  • Clinical evaluation means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data about a device to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer.
  • Clinical evidence means clinical data and clinical evaluation results about a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s), when used as intended by the manufacturer.
  • PMS: Post-market surveillance
  • PMCF: Post-market clinical follow up
  • PSUR: Periodic safety update report
  • FSCA: Field Safety Corrective Action
  • CAPA: Corrective Action Preventive Action

Responsibilities​

JD-005​

To design, review and perform the PMS and PMCF plans and elaborate the corresponding reports in which the experiences obtained after production will be reviewed, as well as any other source of information as a result of the active search.

JD-004​

To ensure that this procedure is followed and to review it when required and, together with the JD-005, to design, review and perform the PMS and PMCF plans, and elaborate the corresponding reports.

Inputs​

  • Serious incidents, non-serious incidents, non-conformities, CAPAs, customer claims and customer feedback related to our products
  • Trend reports
  • Technical assistance tickets
  • Bibliography information
  • Information on safety and performance for similar devices

Outputs​

  • T-007-001 PMS plan
  • T-007-002 PMCF plan
  • T-007-003 Periodic safety update report (PSUR)
  • T-007-004 PMS report
  • T-007-005 PMCF report
  • Update of the T-013-002 Risk management record and T-013-003 Risk management report
  • Update of the T-015-003 Clinical evaluation report

Development​

Integration in the QMS​

This procedure is directly related to the activities described in the procedures GP-006 Non-conformity. Corrective and preventive actions, GP-013 Risk management and GP-015 Clinical evaluation, and complements them.

We will record and notify the adverse incidents detected as a result of this procedure according to procedures GP-004 Vigilance system, GP-006 Non-conformity. Corrective and preventive actions and GP-014 Feedback and complaints. We will analyse them during the annual management meeting and the result of this analysis must be reflected in the T-002-004 Management review report.

Active monitoring of the information received​

The customer complaints and feedback are handled according to the procedure GP-014 Feedback and complaints. The JD-005 together with the people involved, and the JD-004 will take the appropriate steps to solve the detected problems as soon as possible, according to the procedure GP-006 Non-conformity. Corrective and preventive actions.

Periodically, at least once a year, we evaluate the operation of the product: trends, satisfaction of the end user, complaints, and all the information relevant to the product safety and performance as described in the procedure GP-014 Feedback and complaints.

If the JD-005 and JD-004 observe a trend in the number of incidents registered that could end in a non-conformity or an incident, they will act as described in the procedure GP-004 Vigilance system, and complete the trend report form provided by the guidance MEDDEV 2.12-1 rev.8 Vigilance system, Annex VII: Manufacturer's trend report form.

Post-market surveillance system​

The system allows us to systematically and actively collect and analyse the product data, extracting the appropriate data and taking the actions that are necessary in each case. The data collected is used in particular to:

  • Update the benefit/risk ratio determination and the product risk management
  • Update the design and manufacturing information, instructions for use and labelling
  • Update the clinical evaluation
  • Update the summary of the safety and clinical performance
  • Detect needs for preventive, corrective or field safety corrective actions
  • Determine possibilities to improve the usability, performance and safety of the device
  • Contribute, when relevant, to the PMS of other devices
  • Detect and report trends.

The analysis of the information will be carried out as described in the GP-020 Data analysis procedure.

The technical documentation shall be updated accordingly.

Post-market surveillance (PMS) plan​

The T-007-001 PMS plan shall define the activities to collect data related to the post-production phase of the medical device and the methods to collect these data. The PMS plan shall contain at least the following:

  • Information concerning serious incidents
  • Records related to non-serious incidents and data about any undesirable side effects
  • Information about trends in the number of incidents and undesirable side effects
  • Relevant specialized or technical bibliography, databases and registry
  • Information, including feedback and complaints, provided by users, distributors and importers
  • Publicly available information about similar medical devices.

The T-007-001 PMS plan shall cover at least:

  • a proactive and systematic process to collect any information previously referred. The process will allow the correct characterization of the performance of the devices and will also allow comparing the device with similar devices already commercialized;
  • effective and appropriate methods and processes to assess the collected data;
  • suitable indicators and threshold values that will be used in the continuous reassessment of the benefit/risk analysis and risk management;
  • effective and appropriate methods and tools to investigate the complaints and analyze market-related experience;
  • methods and protocols to manage the events subject to the trend report, as well as the observation period;
  • methods and protocols to effectively communicate with the competent authorities, notified bodies, economic operators and users;
  • a reference to the procedures intended to fulfil the manufacturer's obligations about the PMS;
  • systematic procedures to identify and initiate appropriate measures, including corrective actions;
  • effective tools to trace and identify devices for which corrective actions might be necessary;
  • the post-market clinical follow-up activities, documented in T-007-002 PMCF plan.

The results of the activities defined in the T-007-001 PMS plan will be summarised as follows:

  • For class I devices, in the T-007-004 PMS report
  • For class IIa, IIb and III devices in the T-007-003 Periodic safety update report (PSUR)

Post-market clinical follow-up (PMCF) plan​

As part of the described PMS process, the PMCF stands out. We developed the PMCF plan following the European Commission's MDCG 2020-7 guidance.

We proactively collect and evaluate clinical data from the use on or by humans of the device bearing the CE marking and placed on the market.

The T-007-002 PMCF plan is intended to obtain information related to the product, its safety and performance, from the application of a systematic procedure implemented to have sufficient information to update the clinical evaluation, the continued acceptability of identified risks and the detection of emerging risks throughout the product life cycle.

The T-007-002 PMCF plan specifies the methods and procedures for collecting and evaluating clinical data with the aim of:

  • confirming the safety and performance of the device throughout its expected lifetime;
  • identifying previously unknown side-effects and monitoring the identified side-effects and contraindications;
  • identifying and analyzing emergent risks;
  • ensuring the continued acceptability of the benefit/risk ratio;
  • identifying possible systematic misuse or off-label use of the device, to verify that the intended purpose is correct.

The T-007-002 PMCF plan shall cover at least:

  • the general methods and procedures of the PMCF to be applied (gathering of clinical experience, feedback from users, screening of scientific literature and other sources of clinical data);
  • the specific methods and procedures of PMCF to be applied (evaluation of suitable registers or PMCF studies);
  • a rationale for the appropriateness of the methods and procedures;
  • a reference to the relevant parts of the clinical evaluation and the risk management;
  • the specific objectives to be addressed by the PMCF;
  • an evaluation of the clinical data relating to equivalent or similar devices;
  • reference to any relevant common specification, harmonized standards, and relevant guidance on PMCF;
  • a detailed and adequately justified schedule for PMCF activities (analysis of PMCF data and reporting) to be undertaken.

Finally, the conclusions of these activities will be documented in the T-007-005 PMCF report.

Corrective and preventive actions​

The PMS may also be the tool to provide information about non-conformities or potential non-conformities that require corrective action(s) or preventive action(s) (CAPA). Any actions required to correct deviations detected by the data analysis, even before they appear, will be carried out in accordance with the provisions of the procedure GP-006 Non-conformity. Corrective and preventive actions and they will be documented using the T-006-001 Non-conformity report and T-006-003 CAPA.

When required (adverse incident detected or Field Safety Corrective Action (FSCA), among others), the National Competent Authorities or Notified Bodies will be notified following the procedure GP-004 Vigilance system.

In addition, the sanitary alert databases will be consulted to find possible incidents that were notified related to similar devices (as part of PMS activities). The list of sanitary databases that can be consulted is documented in T-007-006 Sanitary alerts databases.

Technical assistance service​

The technical assistance service is described in the procedure GP-017 Technical Assistance Service and the analysis of the tickets related to technical assistance is based on the procedure GP-013 Risk management and the necessary actions are taken according to the incident type and its priority. If a non-conformity is detected, it will be managed by the procedure GP-006 Non-conformity. Corrective and preventive actions, and when they may result in an incident or require notification, will be treated according to the GP-004 Vigilance system.

Databases and registries​

The JD-005, or the person designated by the JD-005, performs bibliographic reviews and consultation of scientific publications and websites. The most important consultation websites are:

  • https://www.aemps.gob.es/productos-sanitarios/productossanitarios_prodsanitarios/
  • http://imdrf.org/safety/safety.asp
  • https://www.medtecheurope.org
  • https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en
  • https://ec.europa.eu/info/policies/public-health_en
  • https://www.nbog.eu/
  • https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm
  • https://www.nature.com/
  • https://www.sciencedirect.com/
  • https://scholar.google.es/
  • https://www.elsevier.es/es
  • https://pubmed.ncbi.nlm.nih.gov/
  • https://www.cisa.gov/
  • https://www.enisa.europa.eu/

The goal of this activity is to review the main databases and websites to gather information about scientific publications, similar devices' safety and performance, new or revised applicable regulatory requirements and ISO standards, and new cybersecurity risks.

The JD-005 and JD-004 will record all the applicable regulatory changes or modifications, communicating to the rest of the employees in writing, according to the criticality that they consider, being possible the immediate communication of said changes.

If necessary, the JD-004 will convene a meeting to expose the modifications and their consequences. Any changes will always be analysed at the next management review according to the procedure GP-002 Quality planning.

Risk management​

Risk management related to the product and its associated processes is performed and documented in the Technical File of the product, by procedure GP-013 Risk Management.

If any new risks are detected as a consequence of the post-market surveillance activities, the JD-005 and JD-004 will update the Technical File accordingly.

Clinical evaluation​

We review the Clinical Evaluation Report (CER) of the medical device according to the results of the post-market surveillance activities and modify or update when required according to the procedure GP-015 Clinical evaluation. The purpose of this review is to verify compliance with the general safety and performance requirements that are documented in the Technical File of the product and to add any new clinical data available for the medical device placed on the market.

Periodic Safety Update Report (PSUR)​

The results of the activities planned for the post-market phase described in the T-007-001 PMS plan are documented in the T-007-003 Periodic safety update report (PSUR). This applies to devices classified as IIa, IIb and III. The report contains at least the following:

  • The conclusions to be used in determining the benefit/risk ratio;
  • The main results of the PMCF activities;
  • The volume of sales of products and an estimate of the size and other characteristics of the population that uses the product and, if feasible, the frequency of use of the product.

The PSUR will include, at least, the following points:

  • Results of the activities established in the T-007-001 PMS plan;
  • Results of the activities established in the T-007-002 PMCF plan;
  • Review of the updated status of the applicable technical and legal regulations;
  • Review and summary of the main non-conformities and CAPAs associated with the device;
  • Review and summary of customer complaints associated with the device;
  • Review and summary of trends in the frequency or severity of incidents (that are not serious incidents);
  • Clinical data from user experience. Clients will be contacted to actively request their feedback regarding the functionality, safety, ease of use and usability of the device;
  • Revision of cybersecurity requirements and state-of-the-art;
  • Any other source of information for PMS.

This report should be the starting point to actively update the T-015-003 Clinical evaluation report of the product, if necessary, and to update the T-013-002 Risk management record and T-012-003 Rik management report in case new risks associated with the product are identified, or if the estimated risks are no longer acceptable, or if severity/probability scores of existing risks are modified.

The report T-007-003 PSUR is written following the MDCG 2022-21 Guidance on periodic safety update report (PSUR) according to regulation (EU) 2017/745 (MDR). This applies to medical devices classified as IIa, IIb and III.

The results of the post-market surveillance activities for medical devices classified as class I are documented in the T-007-004 PMS report that has a very similar structure as the T-007-003 PSUR.

Frequency of updates​

The T-007-003 Periodic safety update report (PSUR) shall be updated:

  • when necessary and at least every 2 years for class IIa medical devices
  • at least annually for class IIb and III medical devices.

For class I medical devices, the T-007-004 PMS report shall be updated when needed and, since there is not a defined frequency for update set out in MDR 2017/745, we will update it every 2 years.

Associated documents​

  • GP-002 Quality planning
  • GP-004 Vigilance system
  • GP-006 Non-conformity. Corrective and preventive actions
  • GP-013 Risk management
  • GP-014 Feedback and complaints
  • GP-015 Clinical evaluation
  • GP-017 Technical Assistance Service
  • GP-020 Data analysis
  • T-002-004 Management review report
  • T-006-001 Non-conformity report
  • T-007-001 PMS plan
  • T-007-002 PMCF plan
  • T-007-003 PSUR
  • T-007-004 PMS report
  • T-007-005 PMCF report
  • T-007-006 Sanitary alerts databases
  • T-013-002 Risk management record
  • T-013-003 Risk management report
  • T-015-003 Clinical evaluation report

Signature meaning

The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:

  • Author: Team members involved
  • Reviewer: JD-003
  • Approver: JD-004
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Templates
  • Purpose
  • Scope
  • Definitions
  • Responsibilities
    • JD-005
    • JD-004
  • Inputs
  • Outputs
  • Development
    • Integration in the QMS
    • Active monitoring of the information received
    • Post-market surveillance system
      • Post-market surveillance (PMS) plan
      • Post-market clinical follow-up (PMCF) plan
      • Corrective and preventive actions
      • Technical assistance service
      • Databases and registries
      • Risk management
      • Clinical evaluation
      • Periodic Safety Update Report (PSUR)
      • Frequency of updates
  • Associated documents
All the information contained in this QMS is confidential. The recipient agrees not to transmit or reproduce the information, neither by himself nor by third parties, through whichever means, without obtaining the prior written permission of Legit.Health (AI LABS GROUP S.L.)