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Post-Market Clinical Follow Up Report

Use this Post-Market Clinical Follow-Up (PMCF) Evaluation Report template to systematically document and analyze the results of all PMCF activities performed for your medical device, as required by EU MDR. This report is essential for demonstrating ongoing clinical performance, safety, and risk management, and should be completed following the execution of your PMCF plan or when significant new clinical data becomes available. Properly filling out this report supports regulatory compliance and helps maintain your device’s CE mark.
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Post-Market Clinical Follow-Up Evaluation Report

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1. Scope

This report documents the results of all post-market clinical follow-up (PMCF) activities outlined in the PMCF plan for the device.

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2. Manufacturer Information

2.1 Manufacturer Information

Legal Manufacturer Name: Lorem Ipsum Corp.
Address: 1234 Ipsum Avenue, Dolor Sit, Country

2.2 Responsibilities and Contacts

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2.3 Additional Manufacturer Information

Single Registration Number (SRN): SRN123456789
Certificate number: CERT987654321
EMDN code(s): EMDN-001.02.03
UDI-DI: UDI-DI-1234567890

2.4 Device Information

Product or trade name: Sed ut perspiciatis unde omnis.
Software Version: v2.3.1
General description of the device: Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum.
Intended purpose: Ut labore et dolore magna aliqua.
Intended users: Clinicians and trained healthcare professionals.
Intended patient population: Adults aged 18-65 years with diagnosed condition.
Medical condition(s): Chronic pain and related symptoms.
Indications: Indicated for the management of moderate to severe pain.
Contraindications: Not for use in patients with known hypersensitivity.
Warnings: Use only as directed. Monitor for adverse reactions.
Variants and/or configurations: Available in standard and advanced models.
Accessories: Includes charger, carrying case, and user manual.
Class: Class IIb
Classification rule: Rule 9: Active devices for therapy.

2.5 Additional Device Information

Expected lifetime: 5 years under normal use conditions.
Novel Product: No
Novel related clinical procedure: No new clinical procedure required.
Explanation of any novel features: Incorporates advanced sensor technology for improved accuracy.

3. Results of PMCF Activities

This section describes the results of the PMCF activities outlined in the PMCF plan. The planned PMCF activities are in the following table:

PMCF activities included user surveys, registry data collection, and post-market clinical studies.

The results can be found below:

Data indicated a low incidence of adverse events and high user satisfaction. No new risks were identified.

4. Technical Documentation

Technical documentation affected from the results of PMCF activities is documented below regarding the clinical evaluation report and the risk management along with any other information deemed relevant.

4.1 Clinical Evaluation

Clinical Evaluation Report:

The relevant information analyzed and monitored from the clinical evaluation:

Survey data, adverse event reports, and literature review findings were considered.

Results of the analzyed and monitored information:

Analysis confirmed the device continues to perform as intended with no significant safety concerns.

4.2 Risk Management

The relevant information to be further analyzed and monitored from the risk management file:

Review of risk management file focused on device malfunctions and user errors.

Results of the analyzed and monitored information:

No new risks were identified; existing controls remain effective.

5. Clinical Data Relating to Equivalent or Similar Devices

This section provides information regarding the evaluation of clinical data. Clinical data related to similar devices and equivalent devices can be found in section 8.3 and 8.4 of the clinical evaluation report, respectively. For additional details related to the evaluation of similar devices and equivalent devices, please refer to the Clinical Evaluation Report.

Comparison with similar devices revealed comparable safety and performance outcomes.
Equivalence analysis demonstrated similar technological characteristics and clinical use.
Literature review supports the clinical performance and safety profile of the device.

6. Common Specification(s), Harmonized Standard(s), and Other Guidance Documents

The following list includes applicable common specification(s), harmonized standard(s), and applicable guidance documents as they relate to the device.

  • EU Medical Device Regulations (2017/745)
  • MEDDEV 2.7/1 Rev. 4 Clinical Evaluation: A Guide for Manufacturers and Notified Bodies
  • ISO 13485:2016 Medical devices -- Quality management systems -- Requirements for regulatory purposes
  • ISO 14971:2019 Medical devices -- Application of risk management to medical devices
  • ISO 14155:2020 Clinical investigation of medical devices for human subjects -- Good clinical practice
  • IEC 62366-1:2015 Medical devices -- Part 1: Application of usability engineering to medical devices
  • IEC 62304:2006 Medical device software -- Software life cycle processes
  • MDCG 2020-1 Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software
  • MDCG 2020-5 Guidance on Clinical Evaluation – Equivalence
  • MDCG 2020-6 Guidance on sufficient clinical evidence for legacy devices
  • MDCG 2020-7 Guidance on PMCF plan template

7. Conclusions

PMCF activities have confirmed the device remains safe and effective for its intended use, with no need for changes to the risk management or clinical evaluation documentation at this time.

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