PMCF

Maria
1 day ago
3 min read

Post-Market Clinical Follow-Up (PMCF) Under EU MDR: What Manufacturers Need to Know

Under the EU Medical Device Regulation (MDR) 2017/745, Post-Market Clinical Follow-Up (PMCF) is no longer optional. It is a key component of the clinical evaluation process, designed to proactively collect and assess clinical data on a device once it is CE-marked and on the market. For many manufacturers, especially those transitioning from the MDD, PMCF introduces new responsibilities—and opportunities—for long-term compliance and product improvement.

In this article, we’ll explore what PMCF is, when it is required, and how to implement an efficient, MDR-compliant PMCF strategy.

What is PMCF?

Post-Market Clinical Follow-Up (PMCF) is defined in Annex XIV, Part B of Regulation (EU) 2017/745 as a continuous process that updates the clinical evaluation and is part of the post-market surveillance (PMS) system. Its aim is to:

Confirm the safety and performance of the device throughout its expected lifetime.
Detect previously unknown side effects or emerging risks.
Identify systematic misuse or off-label use.
Ensure that the benefit-risk ratio remains favourable.

In practice, PMCF includes collecting real-world clinical data from device users and patients in a systematic, documented way. This helps support the conclusions drawn in the Clinical Evaluation Report (CER) and provides evidence for periodic updates, including the Periodic Safety Update Report (PSUR).

When is PMCF Required?

The short answer: almost always.

Under MDR, manufacturers must either:

Conduct active PMCF, or
Justify in detail why PMCF is not required for a specific device.

PMCF is generally expected for:

Implantable and Class III devices
Devices using novel technologies
Devices with limited clinical evidence under MDD
Devices used in vulnerable populations (e.g., children, elderly)
Products with evolving clinical risks or performance uncertainties

Even for well-established Class I and IIa devices, a documented rationale is required if PMCF will not be conducted.

What Activities Can Be Part of PMCF?

PMCF is not limited to clinical investigations. According to MDCG 2020-7 and MDCG 2020-8, valid PMCF activities include:

PMCF surveys (targeting users or patients)
Registry data analysis
Literature reviews and meta-analysis
Retrospective or prospective observational studies
Follow-up from complaints or vigilance data
Analysis of usage trends or off-label use

The choice of methods must be proportionate to the risk class, novelty, and intended use of the device.

What Should a PMCF Plan Include?

The PMCF Plan, required by Annex XIV of MDR, must define the scope, methods, timelines, and objectives of the follow-up. It typically includes:

Device description and justification for PMCF needs
Specific objectives (e.g., to confirm long-term stability, identify rare complications, etc.)
Methods used (data sources, study types, participant selection)
Data analysis and evaluation plans
Timelines and milestones
Link to risk management and CER updates

Your PMCF Plan must align with the overall Clinical Evaluation Plan (CEP), PMS Plan, and Risk Management File (RMF).

What Is the PMCF Report?

The PMCF Evaluation Report summarizes and interprets the data collected during PMCF activities. It should:

Describe the methodology used and the population involved.
Present findings related to clinical performance and safety.
Identify new or evolving risks.
Provide conclusions and recommendations for updates to the CER, labeling, or risk management.

For Class III and implantable devices, the PMCF report feeds directly into the PSUR, which must be submitted to the Notified Body.

Common Challenges in PMCF Implementation

Manufacturers face several practical challenges:

Lack of historical data under MDD
Limited access to end users for survey or follow-up
Unclear justifications for PMCF exemptions
Inconsistent integration with PMS and CER updates
Budget and resource constraints

To overcome these, it’s essential to develop a cross-functional PMCF strategy involving Regulatory, Clinical, Quality, and Marketing teams—and where necessary, seek support from experienced external consultants.

How AF Pharma Can Help

At AF Pharma, we support manufacturers in designing and executing efficient, MDR-compliant PMCF strategies. Whether you need:

A PMCF Plan from scratch
Justifications for PMCF exemption
Literature reviews and survey design
Alignment with CERs and PMS reports
A complete PMCF Evaluation Report for Notified Body submission

…our team of regulatory experts is ready to help you stay compliant and inspection-ready.

Looking for PMCF support or a free template to get started?Contact us at: www.afpharmaservice.com or email maria@afpharmaservice.com

Do you want it know?