After Sales Clinical Follow-up Plan: Performance Monitoring of Medical Devices

Post Sales Clinical Follow-up (PMCF) Plan and Template

What is Postmarket Clinical Follow-up (PMCF)?

PMCF is the process of monitoring the performance and safety of a medical device in the post-sale period. It aims to review and evaluate clinical data collected throughout the lifetime of the device. Postmarket clinical follow-up is part of the clinical evaluation process and is used to assess the performance of the device in real-world conditions. PMCF monitors the safety, efficacy and health effects of the device, while allowing potential risks to be identified and improvements to be made.

The PMCF process includes the following activities:

Collection of Clinical Data: Data collected during the use of the device.
Clinical Data Analysis: Analyzing the collected data and the efficacy and safety profile of the device.
Risk Management and Improvement: Monitoring risks and making improvements to the design of the device.
Regulatory Compliance: Ensuring compliance with the European Union MDR and other international regulations.

Post-market clinical follow-up (PMCF) is recognized by the Medical Device Regulation (EU) 2017/745 as a continuous process that updates the clinical evaluation and should be addressed in the manufacturer's post-market surveillance (PMS) plan.

The scope of the PMCF plan is the methods and procedures established by the manufacturer to proactively collect and evaluate clinical data from the use in humans of a CE marked medical device placed on the relevant market or put into service.

Purpose of the PMCF Plan

Verification of the safety and performance of the medical device throughout its lifetime, where applicable,
Identification of side effects and monitoring of identified side effects and contraindications,
Identify and analyze emerging risks,
Ensure the continued acceptability of the benefit-risk ratio referred to in 1 and 9 of Annex I of the MDR,
Identify possible systematic misuse and off-label use of the device to verify its intended use.

The PMCF evaluation report, which is part of the clinical evaluation report and technical documentation, is a report prepared by the manufacturer, including PMCF analyzes and results. The prepared PMCF plan is evaluated by the notified body. MDR's main objective with the creation of the PMCF plan is to provide guidance to manufacturers for compliance with the relevant requirements.

PMCF Plan Template

Title Page

Device Name
Manufacturer Name
Date of Preparation of the PMCF Plan
Revision Number and Date

Introduction

Device Description
Intended Use
Indications
Risk Profile and Previous Clinical Data

Clinical Data Collection Needs

Post-Sales Clinical Data: What types of data will be collected (safety, efficacy, side effects, etc.)
Data Collection Sources: Patient records, clinical trials, surveys, etc.

Monitoring Methods and Plan

Monitoring Methods: Clinical follow-up, patient feedback, health reports
Data Analysis Methods: How to analyze the data, which parameters to consider

Clinical Follow-up Process and Timeline

Follow-up Period: 1 year, 2 years, etc.
Monitoring Stages: Initial, mid-term and long-term monitoring
Follow-up Periods: At regular intervals such as 6 months, 12 months

Risk Management and Remediation

Risk Analysis: Potential risks and side effects
Corrective Actions: Measures to be taken to mitigate risks

Regulatory Compliance Requirements

MDR/IVDR Compliance: Compliance with European Union regulations
FDA Compliance: US regulatory requirements
Reporting: After-sales reporting process

Results and Evaluation

Analysis of collected data
Evaluation of the safety and effectiveness of the device

Attachments

Data collection questionnaires, risk assessment forms, etc.

Nanolab Laboratories Group continues to provide services within the scope of Medical Device Analysis.

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