Post-Market Clinical Follow-up

Bringing a medical device to the European market implies you must go through various stages of design and development to
ensure compliance with relevant regulations. For devices in the pre-market phase, the EU Medical Device Regulation (MDR 2017/745) places significant emphasis on the connection between 
Risk Management and Clinical Evaluation. Additionally, in the post-market phase, Post-Market Surveillance (PMS) becomes an integral component.

Want to know more about PMCF? Our experts are happy to help. Don’t hesitate to contact us for more information.

Post-Market Clinical Follow-up

Pre-market vs Post-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. 


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.


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.

PMCF Chart

Why QbD Group?

The QbD Clinical 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, QbD Clinical can also provide robust support in documenting your PMS and Clinical Evaluation processes, ensuring thorough preparation for scrutiny by your Notified Body


Contact us


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.

Come visit our booth at CPHI Barcelona 2023

Come to see the QbD Group at stand #3G73 at CPHI Conference in Barcelona. And after the conference…Eat & Connect with lifescience professionals at our QbD’s CPHI Networking Drink.