Medical Device PMCF Plans, Surveys, and Reports

If you market devices in Europe, you already know that your clinical evaluation obligations under the EU Medical Device Regulation don’t end when you get CE Marking. The Medical Device Regulation (MDR) requires you to proactively gather data to assess ongoing device safety and performance. Known as Post Market Clinical Follow-up, PMCF is an important part of your overall Post Market Surveillance (PMS) activities. NAMSA can help you strategize on which data to collect, how to collect it, and prepare a robust PMCF report that meets the expectations of your Notified Body.

Quick facts about Post Market Clinical Follow-up: 

• Required in Article 61 and Annex XIV (Part B) of the European MDR (2017/745)
• Critical component of Post Market Surveillance activities
• Applicable to all classes of medical devices, even those with a long and safe performance record
• PMCF report becomes part of your Clinical Evaluation Report (CER)
• Applies throughout entire life cycle of the medical device
• Intensity of PMS proportionate to risk class and type of device

How NAMSA Can Help You Meet PMCF Requirements

Post Market Clinical Follow-up is a systematic process and consists of several phases as seen below.

Step 1: We Can Help You Define Your Strategy

We work with our clients to create a solid PMCF strategy before rushing directly into planning mode. Why? To satisfy MDR requirements (and your Notified Body) it’s important that you collect the right data in the right way. To come up with a strategy, NAMSA will evaluate several factors including costs, practicality, timelines, quantity of marketed devices, scientific rationale and business decisions. We will outline a strategy with input from you and our clinical and regulatory teams. Once the strategy has been agreed upon, we use it to inform decisions on your PMCF plan.

Step 2: Use Your Strategy To Craft A Medical Device PMCF Plan

The PMCF plan is a document which outlines what PMCF activity(s) you plan to carry out for a particular device. MDCG 2020-7 provides a deceptively simple template for creating a PMCF plan. This PMCF template tells you what is needed, but not how to do it or what your Notified Body expects of you. Our in-house clinical and regulatory teams have assisted medical device manufacturers worldwide with Post Market Clinical Follow-up and will develop a thorough PMCF plan that specifies the methods and procedures you will use to collect data and how you will:

• Confirm the ongoing safety and performance of your medical device
• Identify unknown side effects, emergent risks, off-label use or systematic misuse
• Ensure that the benefit-risk ratio outlined in your risk management plan is still acceptable

In most cases, post market clinical studies will not be required if available data is adequate and the risks posed by your device are low. Typically, other activities such as literature reviews and surveys may be sufficient. If that’s the case, we will justify this in your PMCF plan.

Step 3: Gather Data Via PMCF Surveys, Registries, And More As Specified In Your Plan

Although the EU MDR allows some exceptions, for most devices PMCF data must gathered continually. Post market surveys are one of the most commonly used methods of collecting data from users and patients. NAMSA has deep experience designing, fielding and analyzing PMCF surveys, along with many other sources of post market data as shown below. Our team will help you collect new PMCF data and review existing data you have available from sources including:

• High quality clinical surveys
• Focus groups
• Individual case reports
• Usability surveys including feedback from doctors or patients
• Feedback from sales or account managers
• Published literature on current “state of the art” or equivalent devices
• Clinical registry studies
• Full or partial scope post market clinical studies

Conducting A Medical Device PMCF Study

The depth and breadth of data collected will largely depend on the risk class of your device. If the medium or long-term safety and clinical performance of your device is well documented with real world evidence, a post market clinical study may not be required. However, if a PMCF study is required, NAMSA has teams based in the US and Europe who can plan and manage your study, including protocol development, study management, patient/user recruiting, biostatistics and more.

Step 4: Write The PMCF Evaluation Report

After all data has been collected and evaluated, it’s time to write the report. Once again, there’s a template for that! MDCG 2020-8 provides a basic framework for what should be included. Because NAMSA has worked on so many PMCF projects representing a wide variety of devices, we have a very good sense of what Notified Bodies are looking for. Data from the report will be used to update your clinical evaluation report, risk management file, Summary of Safety and Clinical Performance, etc. Again, because we are one of the largest medical device CROs, we have the in-house expertise to handle all aspects of your PMCF project, from strategy to study to summary reporting.