The Medical Device Regulation (MDR) deadlines are closing in for re-certification and/or introduction of new products. This requires manufacturers to start Post-market Clinical Follow-up (PMCF) activities to fulfil the requirements set out in Annex XIV, part B of the MDR.
In this post, we dive into the requirements for PMCF, its advantages, and its pitfalls. Following which we present a practical guide to use for PMCF activities.
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”
What the above means is that the goal of PMCF activities is to update the clinical evaluation report with up to date data. It ensures that once approved, safety and performance results are continuously available to the market. And, the goal of the PMCF plan is to specify the methods and procedures used to proactively collect and evaluate this clinical data in relation to the product’s safety (hereunder identifying previously unknown side-effects) as well as clinical performance.
Also, it is important to look at the bigger picture and to bear in mind that your PMCF plan is a part of your Post-Market Surveillance (PMS) plan. The data you collect from your PMCF activities feeds into your PMS program which is used in your clinical evaluation process.
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.
Although the PMCF requirements of the MDR will undoubtedly increase the costs of conducting PMCF activities, this is also an opportunity to use it to your advantage. Previously, marketing/sales departments were often not involved in PMS activities and only regulatory and safety/vigilance team governed these. PMS activities are often seen as a “necessary side-effect of having a medical device on the market”.
But, with PMS activities becoming proactive, it 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 messaging 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.
Here are some of the pitfalls from a prospective clinical data collection perspective that you need to be aware of:
PMCF studies might need the approval of ethical committees. This can prove to 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 ́ll want to seek assistance from colleagues who have submitted ethical approval applications before.
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 taken into account. The key to compliance lies in selecting systems that guarantee the correct security and safety measures (such as adequate encryption of data in storage or transmission) and obtaining clear informed consent from respondents/patients.
The clinical staff of hospitals and clinics around Europe will receive an overwhelming amount of requests. Device companies will need access to clinical outcomes and safety data. Now, more than ever 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 some PMCF activities.
Now that you are aware of a few of the advantages and pitfalls of conducting PMCF activities below we present a Practical Guide.
Getting all the elements of the PMCF right can be a difficult task. The PMCF plan and activities shall, according to 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 sources of clinical data. So how should you go about this process?
As with clinical studies, it's always a good idea to start thinking about what results you would like to present in your end-results, which in this case is your PMCF evaluation report. Design your PMCF plan with that in mind and break requirements down into pieces, before you decide on what activity you will conduct. See how to plan for a 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 as well as providing a framework for setting up a PMCF study.
Patients have proven to be extremely motivated to give product, performance, and safety feedback to manufacturers when given the chance. There might be a commercial side to your PMCF that your sales or marketing departments would like to explore. Think of factors such as usability, quality of life, or individual patient statements about your product.
Create a list of those involved in your PMCF activities. 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 to distributors. Note down 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 of off feedback - either their own or for the group as a whole. Others might be hard to motivate but knowing that upfront will assist you with the process.
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. Have a single database, it will save time in preparation for the PMCF evaluation report.
This point isn't preached enough. We ́ve seen this with clinical studies and we will see this with PMCF studies as well. 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, all too often you'll end up with missing data and low response rates. Remember that in-fact less is more! And as your PMCF activities evolve you can change questions and parameters to monitor.
Consider making a PMCF plan template that is 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. 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 you decide on the PMCF 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 down 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 in-fact 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
What tools/resources are you using to fulfil the PMCF requirements of the MDR?
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