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.
New to the EU Medical Device Regulation (MDR)?
This page explains Patient Guard’s Post-Market Clinical Follow-up (PMCF) services, helping manufacturers meet the ongoing clinical evidence requirements of EU MDR 2017/745. If you're looking for a broader introduction to the Medical Device Regulation, including CE marking, Clinical Evaluation, Risk Management, Technical Documentation, Post-Market Surveillance and the role of PMCF under Annex XIV, read our MDR for Beginners – Complete Guide.
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
ph
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.
Related Services
Click on the links below to discover more:
Do you need Training?
Check out Patient Guards Training Courses
Recent Blog Posts
DCB0129 and Clinical Safety: What Digital Health Manufacturers Need for NHS DTAC
For digital health manufacturers preparing to enter the NHS, clinical safety can be one of the most important—and sometimes misunderstood—parts of DTAC.
It is not enough to demonstrate that your software works.
Manufacturers need to consider what could happen if the technology fails, produces incorrect information, presents information incorrectly, contributes to a workflow error or is used in circumstances that could expose patients to harm.
This is where clinical risk management and DCB0129 become particularly important.
NHS England identifies DCB0129 as the clinical risk management standard for manufacturers of health IT systems. Its counterpart, DCB0160, applies to health organisations deploying and using health IT systems. NHS England states that compliance with these standards is required under the Health and Social Care Act 2012.
For manufacturers working towards NHS DTAC readiness, understanding the distinction—and having the right clinical safety evidence—is essential.
DTAC Requirements Explained: The 5 Areas Digital Health Manufacturers Need to Get Right
If your digital health technology is heading towards the NHS, understanding the Digital Technology Assessment Criteria (DTAC) should be part of your market-access planning.
But one of the biggest mistakes manufacturers can make is treating DTAC as simply another questionnaire to complete.
The questions are only part of the process.
Behind your answers needs to be evidence showing that your technology and organisation have appropriate arrangements for clinical safety, data protection, technical security, interoperability, and usability and accessibility.
These five areas form the core of NHS DTAC. NHS England describes DTAC as national baseline criteria for digital health technologies entering NHS and social care.
For digital health manufacturers, the practical question is therefore not simply:
“Can we complete the DTAC assessment?”
It is:
“Can we demonstrate that our product meets the requirements?”
This guide looks at each of the five DTAC areas, the types of evidence manufacturers should consider and some of the common gaps that can delay NHS readiness.
The Complete Guide to NHS DTAC Compliance for Digital Health Manufacturers
A complete guide to NHS DTAC compliance for digital health manufacturers, covering the five DTAC assessment areas, required evidence, clinical safety, data protection, technical security, interoperability and usability, and how to prepare your digital health technology for NHS procurement.
Cosmetic Product Safety Report (CPSR): A Complete Guide to UK Cosmetic Compliance
Before a cosmetic product can legally be placed on the UK market, manufacturers and Responsible Persons must demonstrate that it is safe for human use under normal or reasonably foreseeable conditions. The Cosmetic Product Safety Report (CPSR) is one of the most important regulatory documents required under the UK Cosmetics Regulation. This guide explains what a CPSR is, who can prepare one, what information it must contain, how it relates to the Product Information File (PIF) and how it supports legal cosmetic compliance.
IVDR PMPF Explained: A Complete Guide to Post-Market Performance Follow-up
Post-Market Performance Follow-up (PMPF) is a fundamental requirement under the EU In Vitro Diagnostic Regulation (IVDR), ensuring that manufacturers continually monitor the scientific validity, analytical performance and clinical performance of their in vitro diagnostic medical devices after CE marking. This guide explains IVDR PMPF requirements, PMPF Plans, PMPF Reports, Annex XIII expectations and how ongoing performance monitoring supports continued regulatory compliance throughout the device lifecycle.
IVDR Scientific Validity Explained: A Complete Guide for Manufacturers
Scientific Validity is the first pillar of IVDR Performance Evaluation and provides the scientific foundation demonstrating that an analyte or biomarker is associated with a specific clinical condition or physiological state. This guide explains Scientific Validity under Regulation (EU) 2017/746, including literature reviews, Scientific Validity Reports, Annex XIII requirements, evidence appraisal and how Scientific Validity supports successful CE marking.
