Increasing data entry compliance in PMCF studies

Post-Market Clinical Follow-up (PMCF) is a vital component of any successful MDR compliance strategy. MDR Annex XIV Part B describes PMCF as:

…a continuous process that proactively and continuously collects and evaluates clinical data on the use of a CE-marked medical device.

Furthermore, the MDR states that PMCF should relate to the intended purpose of the device and have the aims of:

  • confirming safety and performance throughout the expected lifetime of the device
  • ensuring the continued acceptability of identified risks
  • detecting evidence of any emerging risks that were previously unknown

In order to meet this diverse range of objectives, PMCF studies need to have a solid implementation strategy alongside a robust design. A key part of any PMCF implementation strategy must be a focus on ensuring high levels of data collection compliance and minimising gaps in datasets which could otherwise be held to be potential sources of bias.

5 methods every medical device manufacturer should know to improve their Post-Market Clinical Follow-up studies

Promoting high levels of data entry compliance is a challenge in conducting any clinical investigation. Given that PMCF is intended to run throughout a device’s entire lifetime, devising ways of increasing and maintaining investigator engagement is central to long-term success.

Here are five methods for keeping investigators locked in:

1. Simplicity

Keep it simple. Clinical investigations that try to collect too much data are cumbersome to work with. Investigators often have very limited time and are accommodating data entry around their other commitments, meaning that cumbersome studies cannot be consistently integrated into their working day. Keep it lean and focus only on the essentials.

2. A smooth user experience

Related to simplicity, choose your data entry system carefully. While most studies will now use an eCRF for data entry, not all interfaces are equally easy to work with. Ensure you work with a system that prioritises a smooth user experience and minimises the opportunity for frustration during data entry. It is also worth remembering that hospital-based IT systems may have limited power and are often part of a shared network, meaning that resource-heavy platforms may function poorly. It is also the case that data connectivity for handheld devices may be limited within certain clinical areas.

3. Effective communication

Don’t leave investigators feeling as though they are operating in a vacuum. Keep in touch with them and ensure that heavy recruiters know that their efforts are appreciated. It’s also a great way to ensure that any “niggling” problems are resolved immediately.

4. Reciprocal benefit

PMCF studies have obvious benefits for manufacturers, helping to maintain regulatory approval of their devices and collecting crucial evidence on device safety and performance. Effectively encouraging investigator compliance calls for a PMCF study that also offers benefits for the healthcare professional. Opportunities for publications, podium presentations, and participation in investigator meetings all help, along with facilitating use of the data for internal clinical audits and performance reviews and a fair remuneration structure. At the outset of study design, consult with prospective clinical investigators and gain a deep understanding of what most benefits them.

5. Review, change and update

Take the time to ensure that the study design is working effectively. Make changes in line with investigator feedback and let them know that their comments and ideas have been implemented. Reacting to investigator feedback not only makes them feel valued; it also helps ensure that the study is best aligned to the needs of those who use your devices in practice.

Post-Market Clinical Follow-up is most effective when powered by comprehensive and complete datasets. Using the tips in this article will give your PMCF studies the best chance of meeting these objectives.

Related articles

  1. Keeping medical devices in market and maintaining CE-marks - a guide to effective data collection

    Keeping medical devices in market & maintaining CE-marks

    The 4 golden rules to drive regulatory compliance with PMCF and vigilance data collection.

    Dr Paul Hercock Dr Paul Hercock
  2. How PMCF goes beyond simple compliance - improving products and engaging customers

    How PMCF goes beyond simple compliance

    The wider benefits of a well-designed PMCF system include improving your products and your relationship with your clients.

    Dr Paul Hercock Dr Paul Hercock
  3. PMCF systems for medical devices

    Why you'll almost certainly need a PMCF system for your medical devices

    We tell you what to be aware of under the EU MDR regarding PMCF and your medical devices.

    Dr Paul Hercock Dr Paul Hercock
  4. Our online PMCF Checker shows if your medical device requires a PMCF system

    Does my medical device need a PMCF system for MDR compliance?

    Answer 10 quick questions to check whether your medical device requires a PMCF system.

    Matthew Stinson Matthew Stinson
  5. Why medical doctors can drive MDR compliance

    Why medical doctors can drive MDR compliance

    Working with the MDR requires knowing how to work with clinical evidence. Medical doctors are perfectly positioned to meet this requirement.

    Dr Victoria Cartwright Dr Victoria Cartwright
  6. clinical investigator for pmcf eu mdr compliance

    Ensuring that clinical investigations work in practice

    How can medical device manufacturers ensure valid clinical investigations when access to medical expertise remains limited?

    Dr Paul Hercock Dr Paul Hercock
  7. EU regulators may delay MDR enforcement

    EU regulators may delay MDR enforcement. Out of the woods?

    A delay of the MDR would be welcome news for many, but what would a delay mean in practice? To what extent can preparations for EU MDR be put on ice?

    Dr Paul Hercock Dr Paul Hercock
  8. The new MDR compliance challenge

    The new MDR compliance challenge

    Across the industry, medical device companies are facing challenges in meeting the demands of the new Medical Device Regulations (MDR) 2017/745 framework.

    Dr Paul Hercock Dr Paul Hercock
  9. Sources of Real World Evidence for MDR compliance

    Sources of Real World Evidence for MDR compliance

    At Mantra Systems our objective is to make sure that our clients choose the method of real world data harvesting that is right for them.

    Dr Paul Hercock Dr Paul Hercock

More articles

Do you need help with your MDR strategy?

Talk with us

Hello there…