Post-Market Clinical Follow-Up (PMCF) Services (EU MDR Compliance)
Our Post-Market Clinical Follow-Up (PMCF) services support medical device manufacturers in meeting EU MDR requirements for ongoing clinical evaluation. Patient Guard provides expert guidance to ensure your PMCF activities demonstrate safety, performance, and continued compliance throughout the product lifecycle.
Post-Market Clinical Follow-Up (PMCF) Services
Post-Market Clinical Follow-Up (PMCF) is a mandatory requirement under EU MDR (EU 2017/745), forming a key part of your Post-Market Surveillance (PMS) system and Clinical Evaluation.
PMCF involves the proactive collection and evaluation of clinical data after a device has been placed on the market to confirm safety and performance and identify emerging risks.
Manufacturers must establish and maintain a PMCF plan, collect relevant clinical data, and document findings in a PMCF Evaluation Report (PMCFER).
Patient Guard acts as your PMCF consultancy partner, supporting the development, execution, and maintenance of compliant PMCF activities aligned with EU MDR, MEDDEV 2.7/1 Rev. 4 and MDCG guidance expectations.
Without a robust PMCF system, manufacturers risk non-conformities, Notified Body findings, and potential delays in CE marking or recertification.
Patient Guard provides expert PMCF services tailored to your device classification, risk profile, and clinical strategy. We ensure your PMCF activities are proportionate, justified, and fully compliant.
Why Choose Patient Guard for PMCF?
Clinical and regulatory expertise
We align PMCF activities with EU MDR, MEDDEV, and Notified Body expectations.
Established regulatory consultancy since 2017
We specialise in clinical evaluation and EU MDR compliance.
Trusted by 500+ companies
We support manufacturers across all device classes and technologies.
Proportionate and efficient strategies
We design PMCF plans that are compliant without being unnecessarily burdensome.
End-to-end support
From planning through to reporting and updates.
Transparent pricing
Clear project-based pricing with no hidden costs.
What Our PMCF Service Includes
Clinical and regulatory expertise
We align PMCF activities with EU MDR, MEDDEV, and Notified Body expectations.
PMCF Plan development
We develop a compliant PMCF Plan aligned with Annex XIV Part B of EU MDR.
PMCF strategy and justification
We support manufacturers across all device classes and technologies.
Clinical data collection planning
We identify appropriate data sources such as literature, registries, surveys, or clinical investigations.
PMCF Evaluation Report (PMCFER)
We prepare compliant PMCF reports summarising findings and conclusions.
Integration with Clinical Evaluation
We ensure PMCF outputs are aligned with your Clinical Evaluation Report (CER).
Post-Market Surveillance integration
We align PMCF with your PMS and vigilance systems.
Ongoing updates and maintenance
We support periodic PMCF updates and regulatory compliance.
Who Requires PMCF?
- Medical device manufacturers under EU MDR
- Class IIa, IIb, and III device manufacturers
- Manufacturers undergoing CE marking or recertification
- Companies with higher-risk or implantable devices
- Organisations with insufficient pre-market clinical data
EU MDR PMCF Requirements
Under EU MDR Annex XIV Part B, manufacturers must:
- Establish a PMCF Plan
- Proactively collect and evaluate clinical data
- Analyse safety and performance during real-world use
- Document findings in a PMCF Evaluation Report
- Update clinical evaluation and risk management documentation
PMCF is essential for demonstrating ongoing safety, performance, and benefit-risk acceptability.
Our Process
Step 1 – Assessment & Planning
We assess your device, classification, and existing clinical data, then develop a compliant PMCF Plan and strategy
Step 2 – Execution & Data Collection
We support PMCF activities including clinical data collection, literature review, and real-world evidence gathering
Step 3 – Reporting & Ongoing Compliance
We prepare the PMCF Evaluation Report (PMCFER) and align outputs with CER, PMS, and risk management, ensuring continued compliance
Industries We Support
We support PMCF services across:
- Medical device manufacturers
- Implantable device companies
- Digital health and SaMD
- Start-ups and global manufacturers
Cost of Service
Post Market Clinical Follow-up (PMCF) Services
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Ensure ongoing EU MDR compliance with expert Post-Market Clinical Follow-up (PMCF) support. Patient Guard develops PMCF plans, supports clinical data collection, and prepares PMCF Evaluation Reports to demonstrate continued safety, performance, and benefit-risk acceptability.
Features
- PMCF Plan development aligned with EU MDR Annex XIV Part B
- Clinical data collection strategy, including literature, surveys, registries, and real-world evidence
- PMCF Evaluation Report preparation to support CER and PMS updates
- Integration with Clinical Evaluation, Post-Market Surveillance, and Risk Management documentation
Time Lines
Weeks 1–2 – Assessment & PMCF Planning
Assess device classification, existing clinical data, and develop the PMCF Plan and strategy
Weeks 3–8 – Data Collection & Analysis
Support PMCF activities, including literature review, surveys, registry data, or real-world evidence collection
Weeks 9–12 – PMCF Reporting & Updates
Prepare the PMCF Evaluation Report and align outputs with CER, PMS, and risk management documentation
Frequently Asked Questions (FAQs)
What is PMCF?
PMCF is the continuous process of collecting clinical data after a device is placed on the market to confirm safety and performance.
Is PMCF mandatory under EU MDR?
Yes, PMCF is a requirement for most medical devices under EU MDR, particularly for Class IIa and above.
Do all devices require PMCF studies?
Not necessarily. PMCF activities must be justified and proportionate to the device risk and available clinical data.
What is a PMCF Evaluation Report?
A PMCFER summarises the results of PMCF activities and confirms whether the device continues to meet safety and performance requirements.
How often should PMCF be updated?
PMCF should be updated regularly as part of your PMS and clinical evaluation cycle.
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