Post Market Clinical Follow-up (PMCF)
Clinical Evaluation should be a lifelong product process. PMCF activities help you build your evidence base whilst you are on market, to show that your product remains safe and effective in the real world.
Post Market Clinical Follow-up (PMCF) is the continuous element of your Clinical Evaluation Report and also relates to your Risk Management File. It involves two document types:
Post Market Clinical Follow-up plans set out what information you will be gathering, why you’ll be gathering it and how often.
Post Market Clinical Follow-up reports contain the data, their analysis and their impact on your Clinical Evaluation Report, Risk Management File and other parts of your technical file.
The data you collect will need to take many different forms to safeguard different aspects of your products’ safety and performance. This includes collating adverse event reporting on device registries, clinical investigations of the product in specific populations and settings, real-world data collection and analysis, end-user surveys and evidence synthesis from publications concerning equivalent products on market.
It also may include specific clinical data you wish to collect in order to substantiate more robust clinical benefits, as well as demonstrate the maintained effectiveness of your product in real-world settings. Often, PMCF activities might involve device registry-style formats of continuous monitoring, or they may include standalone studies. It’s important to note that not all products necessarily need PMCF studies. Depending on the pre-market data you collect, and depending on the risks and benefits of your device, it may be possible to justify the extent of how much PMCF you actually need. Even though you may not need a distinct study, it’s important to remember that PMCF activities are still essential.
Best Practices
Align with internationally recognised standards.
First and foremost, remember that PMCF activities are a clinical subset of general Post Market Surveillance (PMS). In this context, it’s important to follow the regulatory guidance on what is required for post-market surveillance as well as PMCF. The MDCG 2020-7 Guidance offers a template that developers should follow when outlining what their post-market activities are going to be. It’s also worth looking at MDCG 2020-8, the guidance document that Notified Bodies use to evaluate manufacturers’ PMCF reports.
If you are in the US, you will also need to register any PMCF studies with the FDA as a Post Market Surveillance Study.
Finally, if you do need to do PMCF studies or clinical investigations, be sure that they fall within the intended use of your product. If not, you may need to notify the appropriate regulatory authorities (e.g. the MHRA requires notification if a UKCA-marked device is being used outside its intended use). Don’t forget the need to seek ethical approval within your relevant jurisdiction. In the UK, the Health Research Authority states that standard Post Market Surveillance activities don’t count as research, but if you are doing research in a post-market setting, you will need to obtain approval from a Research Ethics Committee.
Whilst following the regulatory guidance is undoubtedly vital, it’s not the end of the story. Done properly, PMCF can offer an opportunity to:
Validate any additional clinical benefits of your software
Collect data relating to future value propositions e.g. time-saving
Implement non-significant changes to improve the user experience
If needed, run further studies or continuous follow-up to ensure that the safety and performance of your software or device is performing as intended in the real world
This means that choosing the right metrics to collect in a PMCF setting is vital, and could propel your product roadmap to the next level. Done well, PMCF can also provide inputs for broader, non-clinical value propositions including health economic modelling.
Case Study
How Hardian solves the problem.
Hardian works with its clients to design Post Market Clinical Follow-up plans that will safeguard the value of their product for years to come and complement any pre-market data they have. We also use Post Market Clinical Follow-up to help clients plan their product’s future and make sure they feel confident in using their plans to produce comprehensive and actionable reports.
Get in touch
Get in touch to see how Hardian can help you to effectively capture your product’s clinical performance on the market.