Background to Post-Market Clinical Follow-up: End-User Surveys

What is PMCF?
Post Market Clinical Follow-up is an essential part of the regulatory framework for medical devices. It involves the continuous collection and analysis of clinical data related to a medical device after it has been released to the market. The primary objectives of PMCF are to ensure the ongoing safety and performance of the device and to identify any potential risks that may arise during its use in real-world settings.

The main goals of PMCF include as per MDCG are:

• Substantiating the performance and safety of the device.
• Identifying and monitoring unknown side effects and contraindications.
• Evaluating emergent risks.
• Confirming that the device’s benefit-risk ratio remains acceptable.
• To check for off-label or misuse use of the device

• End-User Surveys: Collecting feedback from users to gather real-world data on the device’s performance and safety.
• Clinical Studies: Conducting post-market clinical investigations to gather detailed clinical data.
• Registry Data: Using data from patient registries to monitor long-term outcomes and identify trends.
• Literature Reviews: Reviewing published literature to gather information on the device’s performance and safety.

• Cost-Effective: Surveys are relatively inexpensive compared to other methods like randomized clinical trials.
• Real-World Evidence: They provide essential real-world evidence for assessing a device’s safety and performance over its lifecycle.
• Regulatory challenges: These surveys also help to fulfil any kind of regulatory requirements like the new EUMDR2017/745.

What is the existing Clinical Data that you have available? This could vary depending on legacy status, as legacy devices will have a lower level of attention to individual indications. In contrast, novel devices will have restricted pre-market clinical data in their CERs. This is another area of the discussion that pertains to your team’s ability to interpret the requisite changes from MDD to MDR. This transition may identify gaps in data that your team previously did not need to consider.

When deciding to use end-user surveys, manufacturers should consider:

• The volume and substance of the evidence required.
• The effort involved in collecting this evidence.
• The device classification and clinical data relevant to its indications.
• Any gaps in the safety and performance objectives of the device.

Conducting a survey for your medical device can be a valuable part of your Post-Market Clinical Follow-Up (PMCF) activities. Here are some considerations to help you decide:

When to Conduct a Survey

• Newly Launched Devices: If your device is new to the market, surveys can help gather initial real-world data on its performance and safety.
• High-Risk Devices: For devices classified as high-risk, ongoing monitoring through surveys can be crucial to ensure patient safety.
• Regulatory Requirements: If regulatory bodies require additional post-market data, surveys can be an effective way to collect this information.
• Identified Issues: If there have been reports of issues or adverse events, surveys can help identify the extent and nature of these problems

What is the existing Clinical Data that you have available? This could vary depending on legacy status, as legacy devices will have a lower level of attention to individual indications. In contrast, novel devices will have restricted pre-market clinical data in their Clinical Evaluation Reports (CERs). This is another area of the discussion that pertains to your team’s ability to interpret the requisite changes from MDD to MDR. This transition may identify gaps in data that your team previously did not need to consider.

It might also happen that survey might not be the correct route for your devce, that’s why it’s vital to get the proper guidance and considerations in first place. Again, designing research questions that are appropriate is also a challenge. These all need to get right to get correct answers and meet the objective for the PMCF survey.

Luckily, our team has worked on numerous end-user surveys and are able outline some of the most prevalent obstacles. If your team needs guidance, experienced resources, or complete end-to-end PMCF support, please email info@celegence.com or contact us online to connect with a Celegence expert.