Post-Market Clinical Follow-up - Clinical - QbD Group (4)

Post-Market Clinical Follow-up (PMCF)

Bringing a medical device to market is a complex process, and your responsibilities don’t end once the device is CE marked.

To ensure your product continues to meet safety and performance standards, ongoing Post-Market Clinical Follow-up (PMCF) is essential.

This proactive approach helps monitor your device in the real world, providing insights that keep you compliant and safeguard the health of users. And that's where we come in.

Post-Market Clinical Follow-up - Clinical - QbD Group

Pre-market vs post-market

Pre-market

In the pre-market phase, collecting ample evidence to validate the safety and performance of your device is key. That way you ensure the intended use of your device and the claims you prefer to make are supported by robust clinical data while mitigating associated risks as far as possible.

Post-market

In the post-market phase, additional PMS activities are crucial. PMS involves setting up mechanisms for continuous collection of safety and performance data from the real-world use of your device. PMS activities can be either reactive (e.g. vigilance, management of complaints), proactive (PMCF activities) or a combination of both. PMS data help maintaining the continuous safety and performance profile of your device, ensuring that the benefits continue to outweigh the risks.

What is post-market clinical follow-up?

PMCF, as part of the PMS process, involves a proactive collection and evaluation of data from the clinical use of your CE marked device. The process provides valuable insights into the long-term effectiveness of the device, and it is a way to potentially detect emerging risks.

PMCF can be done in various ways. The most common PMCF activities are listed in the table below, each of them providing a different level of evidence. It is important for every Medical Device Manufacturer to identify the activities that are most relevant (general or specific methods), taking into consideration the risk class of the device and the purpose of the post-market data collection.

Type of method	Most common PMCF activities
General method	Case reports
General method	User feedback
General method	Literature/published research on the device safety and performance
General method	Safety database searches (e.g. FDA Maude)
Specific method	Evaluation of registers
Specific method	PMCF Survey
Specific method	PMCF study (interventional or observational)
Specific method	Investigator Initiated studies

The results of PMCF activities, as part of the PMS process, are taken up in the clinical evaluation and as such the process contributes to the ongoing risk management of the device.

Discover how we can help you

Why QbD Group?

Our team is well-equipped to support you in designing and executing various PMCF activities, tailored to their specific regulatory requirements and your device characteristics.

Whether it’s scouring through literature, sifting through customer feedback, or setting up reliable data collection methods. We maintain a strong commitment to attention to detail and strict adherence to regulatory standards.

In addition to assisting with PMCF activities, we can also provide robust support in documenting your PMS and Clinical Evaluation processes, ensuring thorough preparation for scrutiny by your Notified Body.

Get in touch

Interested in our PMCF service? Don’t hesitate to contact us and provide the details of your request including scope and expected timelines. We will contact you shortly to discuss these details and further steps.

Resources

Webinar

Evidence Throughout the Lifecycle: Integrating Clinical Needs into Design & Documentation

Discover how to integrate clinical needs into medical device software design to meet MDR requirements. Watch our webinar on demand.

Whitepaper

Clinical Evaluation for Medical Devices under MDR

This whitepaper will guide you through crucial regulatory documents pertaining to the clinical evaluation process of your medical device. Download now!

Whitepaper

IVDR extension: what does this mean for you?

In this whitepaper, you will learn the impact of the IVDR transition extension and receive tips and strategies to navigate these regulatory changes.

Whitepaper

State-of-the-art literature review: kick off the Clinical Evaluation of your Medical Device

This whitepaper will walk you through the steps of conducting solid systematic SOTA literature searches for your clinical evaluation. Download now.

Whitepaper

Clinical investigations under MDR: key insights and practical experiences

This whitepaper covers clinical investigation authorization under MDR, the EU Legal Representative's role, and the MDR's impact on study conduct and post-market surveillance.

Whitepaper

The pathway from idea to patient under MDR

This guide explains the pathway and steps needed to test your device in human subjects, aiming to get your product to market. Download now.

Case study

CE Mark Renewal for bioXtra Products: A Success Story

Discover how Lifestream Pharma successfully renewed the CE mark for their BioXtra Dry Mouth products under the EU MDR. Learn about the challenges faced, the approach taken for compliance, and the results achieved.

Webinar

Getting Started: Overcoming Initial Obstacles in Medical Device Software Development

Watch our webinar on demand and learn about regulatory obstacles, MDR, AI Act, and best practices for medical device software development and market entry.

Webinar

Mastering Clinical Performance Studies under IVDR

In the evolving regulatory landscape of IVDs, demonstrating clinical performance is more crucial and challenging than ever. Discover more in this webinar on demand.

Whitepaper

Clinical evidence for In Vitro Diagnostics under IVDR

In this whitepaper, we will guide you through the documents required for the demonstration of clinical evidence under the IVDR. Download now.

Case study

Ensuring a smooth MDR transition for Oystershell's medical devices

The landscape of medical device regulations is constantly evolving, making it a challenge for companies to keep up. Our collaboration with Oystershell, which began in July 2023, highlights our expertise in transforming complex challenges into success stories, all with a touch of QbD Clinical magic.

Case study

Successful clinical evaluation supports rapid CE marking of Minze Health's Uroflowmeter

QbD Clinical assisted Minze Health, a urology-focused medical devices company, in obtaining CE marking under MDR through clinical evaluation.

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