A medical device company practical guide to the PMCF requirements of the EU MDR

The European Medical Device Regulation (EU MDR) deadlines are closing in for re-certification and/or introduction of new products. This requires manufacturers to start Post-market Clinical Follow-up (or Post-Marketing Clinical Follow-up) (PMCF) activities to fulfil the requirements in Annex XIV, part B of the MDR. PMCF activities are methods to actively collect data on clinical experience after a medical device has received market authorization (PMCF study, PMCF registry, etc.)

This post will dive into the MDR requirements for PMCF for Medical Devices, its advantages, and its pitfalls. Following, we present a practical guide on best practices for PMCF activities and PMCF plans. Download our free whitepaper here for an even more detailed guide on EU MDR and PMCF for Medical Devices.

You can also watch three success stories of Collecting Clinical Evidence in a Post-Market Setting for a practical example of how to conduct a PMCF study right here:

How does the EU MDR describe Post-Market Clinical Follow-Up activities and subsequent requirements?

Annex XIV, Part B states, “PMCF shall be understood to be a continuous process that updates the clinical evaluation referred to in Article 61 and Part A of this Annex and shall be addressed in the manufacturer’s post-market surveillance plan”

The above means that the goal of PMCF is to update the clinical evaluation report with up-to-date data. It ensures that safety and performance results are continuously available to the market once approved. And, the goal of the PMCF plan is to specify the methods and procedures used to proactively collect and evaluate this clinical data with the product’s safety (hereunder identifying previously unknown side-effects) and clinical performance.

Also, it is important to look at the bigger picture and bear in mind that your PMCF plan is a part of your Post-Market Surveillance (PMS) plan. Therefore, the data you collect from your PMCF activities feeds into your PMS program, used in your clinical evaluation process.

Check our Practical Guide to PMCF EU MDR Compliance for unique insights on all areas of Post-Market Clinical Follow-up.

Now that we have covered the overall goal of PMCF activities and subsequently the goal of the PMCF plan, in the next sections, we address how you can leverage its advantages. But also beware of its pitfalls.

Leverage the Advantages

Although the PMCF requirements of the MDR will undoubtedly increase the costs of conducting PMCF studies, this is also an opportunity to use it to your advantage. Previously, marketing/sales departments were often not involved in PMS activities. Only regulatory and safety/vigilance teams governed these. PMS activities are often seen as a “necessary side-effect of having a medical device on the market.”

But, PMS activities becoming proactive presents an opportunity for marketing departments. With the involvement of marketing departments, the messaging on product performance will improve as they will be able to base their message on the results of the PMCF.

Furthermore, as the PMCF requirements in the MDR are related to those described in Article 61 (Clinical evaluation), it is important to consider who in the organization will have the main responsibility for collecting the prospective clinical data.

In many cases, PMCF projects resemble clinical studies. Therefore, those collecting the prospective data stand to benefit from the experience of the clinical research/affairs teams. Remember to use all your available resources.

PMCF Plan Pitfalls

Here are some of the pitfalls from a prospective clinical data collection perspective that you need to be aware of:

1. Time-Consuming Ethical Approval

PMCF activities might need the approval of ethical committees. This can be a time-consuming task, as ethical committees often require a formal application. Furthermore, committees in different countries can react differently to the application and its contents. This process will increase the overall cost of PMCF activities. If you have not conducted clinical studies before, you will seek assistance from colleagues who have submitted ethical approval applications before.

1. GDPR Compliance

The GDPR is a comprehensive regulation misunderstood by many. Several are afraid of collecting identifiable information because of the GDPR. However, the “implications of the GDPR on Medical Device clinical activities and PMCF” are not as extensive as some might think but have to be considered. The key to compliance lies in selecting systems that guarantee the correct security and safety measures (such as adequate data encryption in storage or transmission) and obtaining clear informed consent from respondents/patients.

1. Missing Key Opinion Leaders

The clinical staff of hospitals and clinics around Europe will receive many requests. Medical Device companies will need access to clinical outcomes and safety data. Now, it is important to maintain a network of Key Opinion Leaders or Clinical Experts that work with your device. If you use distributors to sell your products in the EU, you should collaborate with them on PMCF activities.

Now that you know a few of the advantages and pitfalls of conducting PMCF activities below, we present a Practical Guide.

Practical Guide to the PMCF Plan for Medical Devices

Getting all the elements in the Post-Market (or Marketing) Clinical Follow-Up plan right can be a difficult task. The PMCF plan and activities shall, according to EU MDR Annex XIV Part B paragraph 6.2, include methods for proactive clinical data collection to ensure that safety, performance, user feedback, and clinical experiences are gathered. Furthermore, manufacturers shall systematically screen scientific literature and other clinical data sources. So how should you go about this process?

Start at the End and Seek Inspiration

As with clinical studies, it’s always a good idea to start thinking about what results you would like to present in your results, which is your PMCF evaluation report. Then, design your PMCF plan with that in mind and break requirements into pieces before deciding what activity you will conduct. See how to plan for a Medical Device PMCF study using EDC.

Furthermore, manufacturers can benefit from seeking inspiration in ISO14155 (Clinical investigation of medical devices for human subjects — Good clinical practice). The standard will assist you with handling ethical questions and providing a framework for setting up a PMCF study.

Don’t Forget the Commercial Side.

Patients have proven extremely motivated to give product, performance, and safety feedback to medical device manufacturers when given a chance. There might be a commercial side to your Post-Market Clinical Follow-Up that your sales or marketing departments would like to explore. Think of usability, quality of life, or individual patient statements about your product.

Get an Overview of those Involved in the PMCF process.

Create a list of those involved in your PMCF plan. Everyone from product managers (relating to known side-effects to be monitored) to your end-users will be a part of this list. List specific titles and/or names from clinical staff, regulatory staff, patients, and distributors. Note what motivates these individuals to provide you with what you need and think of what you can do to motivate them. For example, patients are known to thrive off feedback — either their own or for the group. Others might be hard to motivate but knowing that upfront will assist you with the process.

Global PMCF Registry as an Option

Medical Device Manufacturers with products in multiple countries will benefit from setting up a single PMCF registry. This allows the manufacturer to collect PMCF related clinical data in one location. Modern systems provide translation modules that enable patients and professionals to feed safety and performance data into a central database. This will also enable you to ask distributors to help with this work. Having a single database will save time preparing for the PMCF evaluation report.

Less is more

This point isn’t preached enough. We’ve seen this with clinical studies, and we will see this with PMCF studies. Manufacturers tend to ask for too much data. Arguments such as ‘while we are at it, we might as well’ are used to justify this. However, you’ll often end up with missing data and low response rates. Remember that less is more! And as your PMCF study activities evolve, you can change questions and parameters to monitor.

Reusability is your Friend

Consider making a PMCF Medical Device plan template reusable across products and markets. Furthermore, you can make generic product-related questions for safety and performance. Also, you can select specific scales to track both. Finally, depending on the system you choose to build your PMCF registry/study with, you will be able to copy and paste studies/forms.

In conclusion, getting all the elements of the PMCF right can be a difficult task. So Use this guide

1. Start at the end and seek inspiration. Start by defining what data you need to present before deciding on the PMCF study activity.

2. Don’t forget the commercial side. Your sales & marketing teams will benefit from your PMCF data.

3. Create a list of those involved in your PMCF activities and note what motivates these individuals to provide you with what you need. Then think of what you can do to motivate them.

4. Have a single database. This will save time in preparation for your PMCF evaluation report.

5. Remember that less data is more. At a later stage, you can change questions and parameters to monitor.

6. Make a PMCF plan template that is reusable across products and markets

Useful Resources:

· How the EU MDR Compliant Clinical Evaluation Reports are written: The Regulatory Challenges?

· How to choose the best clinical evaluation report writer?