account_balance

Post-Market Clinical Follow Up Plan

Use this Post-Market Clinical Follow-Up (PMCF) Plan template to systematically outline your planned activities for ongoing clinical data collection and safety monitoring of your medical device after it enters the market. Completing this document is essential for demonstrating continued device safety, performance, and benefit-risk acceptability, and should be filled out prior to or upon market launch, with updates as new post-market data or risks emerge. This template ensures you meet EU MDR requirements for proactive post-market surveillance and provides a structured approach for regulatory compliance and technical documentation.
Generate ->

Post-Market Clinical Follow-Up Plan

ID: Lorem ipsum dolor

1. Scope

This document concerns the post-market clinical follow-up (PMCF) plan for Dolor sit amet device. More information regarding the PMCF process can be found in the SOP Clinical Evaluation.

2. Manufacturer and Device Information

2.1 Manufacturer Information

Legal Manufacturer:\
Consectetur Technologies

Address:\
1234 Ipsum Avenue, Lorem City, LX 56789

2.2 Responsibilities and Contacts

Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat.

2.3 Device Information

Product or trade name\
Dolor sit amet device

Software Version\
v2.3.1

General description of the device\
Sed do eiusmod tempor incididunt ut labore et dolore magna aliqua.

Intended purpose\
Ut enim ad minim veniam, quis nostrud exercitation.

Intended users\
Healthcare professionals with relevant clinical experience.

Intended patient population\
Patients requiring targeted therapeutic intervention for dolor.

Medical condition(s)\
Chronic dolor and associated symptoms.

Indications\
Indicated for the management of dolor-related conditions in adult patients.

Contraindications\
Not for use in patients with known hypersensitivity to device materials.

Warnings\
Use with caution in patients with comorbidities. Refer to IFU for details.

Variants and/or configurations\
Available in multiple sizes and configurations for different clinical needs.

Accessories\
Compatible with dolor extension module and remote control unit.

Class\
Class IIb

Classification rule\
Rule 9, devices intended to administer or remove medicinal products.

2.4 Additional Device Information

Expected lifetime: Five years under normal use conditions.
Novel Product: No
Novel related clinical procedure: No
Explanation of any novel features: Device incorporates advanced dolor detection algorithms.

3. Planned Activities and Methods

This section describes the different activities that will be conducted post-market, including general and specific methods / procedures to conduct. Activities are described with their aim, rationale and limitations, and timeline for activities to begin.

The need for additional PMCF activities can arise from the clinical evaluation report, post-market surveillance, and other sources of clinical data. The aim PMCF activities are conducted to perform the following:

  • confirm the safety and performance of the device;
  • to identify any side effects or adverse events that were not previously identified;
  • monitoring intended side-effects and contraindications;
  • identifying and analyzing emerging risks;
  • ensuring continued acceptability of the benefit-risk ratio; or
  • identifying possible systematic misuse or off-label use of the device.

Potential PMCF activities can include but are not limited to:

  • screening of scientific literature and clinical data;
  • post-market studies;
  • collecting data in registries;
  • surveys of healthcare professionals or patients/users; or
  • review of case reports which may reveal misuse or off-label use.

Rationale for the appropriateness of the chosen procedures can include:

  • justification of sample size, timescales and endpoints;
  • justification for comparator, on the basis of intended purpose and state of the art;
  • justification of the study design on the basis of all of the above, and why it is sufficient to ensure representative patient populations and provide for adequate controls on sources of bias (an evaluation of the potential sources of bias should form part of this); or
  • a statistical justification for the expected quality of outcomes, and justification for why this is satisfactory in light of the residual risks. This is an important consideration. For example, retrospective surveys with no justification other than “this should demonstrate the expected quality of evidence that we require,” but without showing a statistical rationale, are not acceptable.

The following table contains all planned PMCF activities for the device:

Annual literature review, user surveys, and registry data analysis will be conducted to monitor safety and performance.

4. Technical Documentation

Relevant information from the technical documentation is included in this section to support the PMCF plan. In particular information from the clinical evaluation report and the risk management file is to be considered along with any other information deemed relevant.

4.1 Clinical Evaluation

The relevant information to be further analyzed and monitored from the clinical evaluation includes:

Review of reported adverse events, device effectiveness, and user feedback from post-market sources.

4.2 Risk Management

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

Assessment of residual risks, analysis of new hazards identified post-market, and evaluation of risk control measures.

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.

Clinical data from similar dolor management devices demonstrate comparable safety and performance profiles. Data from equivalent devices support the intended use and risk profile of the subject device.

Comparative analysis confirms that the subject device meets established safety and performance benchmarks as outlined in the clinical evaluation report.

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. Estimated Date of the PMCF Evaluation Report

The PMCF evaluation report shall be updated at least annually or earlier as necessary if information from PMCF activities necessitates and earlier report. If no PMCF activities are required, in lieu of a report, the plan will be reviewed one year from the current date and updated as necessary.

Medical Device Certification Made Easy.