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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
        • T-007-001 Post-Market Surveillance (PMS) Plan
        • T-007-002 Post-Market clinical follow-up (PMCF) Plan
        • T-007-003 Periodic Safety Update Report (PSUR)
        • T-007-004 PMS evaluation report
        • T-007-005 PMCF evaluation report
        • T-007-006 Sanitary alerts databases
    • 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-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
  • Records
  • TF_Legit.Health_Plus
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  • External documentation
  • Procedures
  • Records
  • Procedures
  • GP-007 Post-market surveillance
  • Templates
  • T-007-005 PMCF evaluation report

T-007-005 PMCF evaluation report

PMCF evaluation report details​

  • Correcponding PMCF plan number and version:
  • PMCF report number:
  • PMCF report date:
  • PMCF report version:

Manufacturer contact details​

Manufacturer data
Legal manufacturer name
Address
SRN
Person responsible for regulatory compliance
E-mail
Phone
Fax

Medical device description and specification​

Refer to this section from T-007-002 PMCF plan, if there are no changes. If there are changes from PMCF plan, please fill in the different requested fields highlighting those changes.

Product information
Product or trade name
Model and type
Product version
General description of the device
Intended purpose
Intended users
Bssic UDI-DI
Intended patient population
Medical condition(s)
Indications
Contraindications
Warnings
List and description of any variants and/or configurations coverred by this plan
List of any accessories covered by this plan
Certificate number (if available)
CND code(s)
Class
Classification rule
Expected lifetime
Novel product (Yes/No)
Novel related clinical procedure (Yes/No)
Explanation of any novel features

PMCF activities​

note

In this section we will report all the activities described in this section of the T-007-002 PMCF plan which have been performed, all the collected clinical data obtained from those completed activities, as well as any justification of deviations from the plan.
The discussion will include the analysis of the findings, whether positive or negative and also the potential impact on the different documents (clinical evaluation report, risk management file, etc…) initially reviewed during the conformity assessment.
It is expected for each activity performed, a description in different subsections, related to the type of activities (device registry, PMCF studies, real world evidence, surveys about the use of device, etc…), and for each subsection, a description about the quality of data collected.

Activity #number#​

Evaluation of clinical data relating to equivalent or similar devices​

Product name of equivalent /similar deviceResults discussedReferences used to get the results

Impact of the results on the technical documentation​

note

In this section we are required to include references to the relevant information from the clinical evaluation report and from the risk management file, which need to be analysed, followed up, and evaluated in this plan. As an alternative, we are required to state that there is no relevant information from the clinical evaluation report and/or from the risk management file to be considered in this plan.

Clinical Evaluation Report (date and version)​

⬜️ No relevant information from the clinical evaluation report to be considered in this plan

Relevant information analyzed and monitored:

Analysis of the outcome is to be reported in the updated clinical evaluation report.

Risk Management File (date and version)​

⬜️ No relevant information from the clinical evaluation report to be considered in this plan

Relevant information analyzed and monitored:

Analysis of the outcome is to be reported in the updated clinical evaluation report.

Reference to any applicable common specification(s), harmonized standard(s) or applicable guidance document(s)​

When new standards, requirements or guides were applied we will update the corresponing section within the product Technical File.

In this section we will point out whether the collected clinical data related the device in question still confirm adherence to applied common specifications and/or applied harmonized standards, and/or guidances listed in the PMCF plan.

Common specifitation(s) to comply with, if applicable​

Harmonised standards to apply, if applicable​

Guidance on PMCF, if applicable​

note

Include title, date and version of each document mentioned

Conclusions​

note

In this section, we will provide an overall conclusion of the findings and relate them to the aims of the corresponding T-007-002 PMCF plan. The conclusions will be taken into account in the following clinical evaluation and in the risk management. Finally, this conclusion will highlight if any need for preventive and/or corrective measures has been identified. The conclusion may also give input to the next PMCF plan.

Record signature meaning​

  • Author: JD-004 Author name
  • Review: JD-005 Reviewer name
  • Approval: JD-001 Approver name

Template signature meaning​

info

Delete this section when you create a new record from this template.

  • Author: JD-004 María Diez
  • Review: JD-005 Alfonso Medela
  • Approval: JD-001 Andy Aguilar
Previous
T-007-004 PMS evaluation report
Next
T-007-006 Sanitary alerts databases
  • PMCF evaluation report details
  • Manufacturer contact details
  • Medical device description and specification
  • PMCF activities
    • Activity #number#
  • Evaluation of clinical data relating to equivalent or similar devices
  • Impact of the results on the technical documentation
    • Clinical Evaluation Report (date and version)
    • Risk Management File (date and version)
  • Reference to any applicable common specification(s), harmonized standard(s) or applicable guidance document(s)
    • Common specifitation(s) to comply with, if applicable
    • Harmonised standards to apply, if applicable
    • Guidance on PMCF, if applicable
  • Conclusions
  • Record signature meaning
  • Template signature meaning
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.)