Developing a PMCF Plan: Your Blueprint for Regulatory Compliance

January 29, 2025 ░░░░░░

Developing a PMCF Plan Your Blueprint for Regulatory Compliance

The Post-Market Clinical Follow-Up (PMCF) is one of the most important parts of the post-market surveillance activities required by EU MDR. Its purpose is to continuously and proactively gather clinical data on the performance, safety, and benefits of your device throughout the product lifecycle.

The key to a great PMCF program is thinking ahead and ensuring that your PMCF activities are capable of generating the data you need. So today, let’s talk about your PMCF plan—the fundamental document of your PMCF program.

BONUS RESOURCE: Click here to download a free checklist for setting up clinical data management in an EDC system!

What is a PMCF plan?

The PMCF plan is the document that specifies the methods and procedures a medical device company will use to proactively collect and evaluate clinical data on their device throughout the product lifecycle. The PMCF plan should describe how the company will:

  • Confirm the safety and performance of the device, including clinical benefit, if applicable, through the lifetime of the device;

  • Identify previously unknown side-effect and monitor known side-effects and contraindications

  • Identify and analyze emergent risks

  • Ensure the continued acceptability of the benefit-risk ratio

  • Identify any possible systematic misuse or off-label use of the device 

What does the PMCF plan contain?

The contents of your PMCF plan are laid out in detail in MDCG 2020-7, the EU guidance document on PMCF plans. Generally speaking, your PMCF plan will include seven sections: 

  1. The manufacturer’s contact details

  2. A description and specification of the medical device being studied

  3. The activities related to the PCMF (these are both the general and specific methods and procedures you’re using)

  4. References to any relevant parts of the technical documentation

  5. An evaluation of clinical data for equivalent or similar devices

  6. References to any applicable common specifications, harmonized standards, or guidance documents

  7. Estimated date of the PMCF evaluation report

The outcome of the activities you document in your PMCF plan will be included in your PMCF report, which mirrors the structure of the PMCF plan. 

Choosing the activities for your PMCF plan

The most important part of developing a PMCF plan is choosing the activities you’ll use to obtain the data you need for your device. A lack of planning in this stage could cause you to miss important data on the safety and/or performance of your device.

PMCF activities fall into two categories: general and specific activities.

General PMCF activities

General PMCF activities use a broad approach to gathering data and often involve accessing existing data sources. In fact, this type of information gathering should already be happening in the course of putting a device on the market. General PMCF activities include:

  • Feedback from users (e.g. from patients)

  • Screening of scientific literature

  • Gathering of clinical experience gained (e.g. from physicians)

  • Other sources of clinical data, such as published data and research on similar devices

General activities can be useful in gathering clinical data, but they’re usually not enough to meet the standards for illustrating the performance and safety of a device. The data obtained from them is often subjective and the quality can vary widely. For example, clinical performance is difficult to prove based solely on subjective physician surveys.

Specific PMCF activities

General activities will likely need to be combined with specific PMCF activities, which include methods like:

  • PMCF studies (or observational or non-interventional clinical investigations)

  • Post-market interventional clinical investigations

  • Evaluation of data from suitable registries

  • Investigator-initiated studies

  • Case cohorts

  • Other subject-specific clinical data collection activities

Specific methods are implemented proactively and they are typically controlled and managed by the manufacturer with the express purpose of obtaining data on a device’s performance.

Tips for creating a strong PMCF plan

It’s impossible to give one-size fits all advice about a PMCF plan due to the huge variety of medical devices and their benefit-risk profiles. However, here are a few tips that you can use to guide your thinking as you begin coming up with your PMCF plan.

Clinical investigations are not your only option

PMCF studies are mentioned regularly throughout EU MDR and related guidance documents, and this sometimes leads MedTech companies to assume that their Post-Market Clinical Follow-up must include a clinical study on their device. But this isn’t necessarily the case. Depending on factors like the risk class of your device, its longevity, and existing clinical data, you may be able to use alternative PMCF activities, such as:

  • Surveys of healthcare professionals

  • Healthcare panel questionnaires or surveys

  • Data collected directly from the device itself

  • Lay user cohorts 

  • Scientific literature

Some devices will require a clinical investigation, but just be sure that your decision about whether to undertake a PMCF study is based on careful consideration of the device itself and any gaps in the existing clinical data.

Have a plan for collecting and managing your clinical data

If you are performing a clinical investigation as part of your PMCF, then you will need to follow the data management practices outlined in ISO 14155:2020, Clinical investigation of medical devices for human subjects - Good clinical practice. These include requirements that any electronic data capture (EDC) system must:

  • Be validated “in order to evaluate the authenticity, accuracy, reliability, and consistent intended performance of the data system.”

  • Ensure attributability, completeness, reliability, consistency, and logic of the data entered.

  • Ensure that data changes are documented and an audit trail is maintained.

  • Maintain a security system to prevent unauthorized use of data, both internally and externally. 

However, even if you aren’t conducting a clinical investigation, you still need to ensure that the data from surveys, for example, is reliable and secure and that the privacy and data rights of respondents are protected. Doing all of that with paper or general software tools like Excel, Dropbox, or Google Drive is not only extremely difficult, it also creates an enormous risk that the data you’ve worked so hard to get won’t be accepted by regulatory bodies. 

Instead, you need a modern and compliant EDC system you can use to collect and manage all of your clinical data for your PMCF.

BONUS RESOURCE: Click here to download a free checklist for setting up clinical data management in an EDC system!

Collect and manage all the clinical data for your PMCF in one place with Greenlight Guru Clinical

With so many different options for collecting clinical data for your PMCF, it’s critical that you choose an EDC system that can handle all your data collection and management needs. 

With Greenlight Guru Clinical, not only will you be able to quickly build your own clinical studies, you’ll also be able to send out post-market surveys and capture ad hoc data from clinicians in a GCP-compliant manner. In fact, Greenlight Guru Clinical is out-of-the-box compliant with ISO 14155:2020 and includes templates for data collection planning and regulatory compliance to reduce the planning burden for your PMCF activities. 

Ready to see how Greenlight Guru Clinical can simplify your PMCF? Then get your free demo of our software→.

Chris is a biomedical engineer and has been in the medical device space for about 13 years. He spent a number of years managing clinical studies for Class III devices in Pivotal studies, PMA studies, and post-market registries. He is currently working as a Solutions Engineer at Greenlight Guru where he showcases the...

How to Plan a Clinical Data Management Setup for EDC Systems
Download Now
How to Plan a Clinical Data Management Setup for EDC Systems - slide in cta (cover)
Search Results for:
    Load More Results