Post-Market Clinical Follow-up (PMCF) of medical devices

A free guide to Post-Market Clinical Follow-up under the Medical Device Regulation (MDR) 2017/745.

What is Post-Market Clinical Follow-up (PMCF)?

Post-Market Clinical Follow-up (PMCF) is an important component of Post-Market Surveillance that applies to almost all medical devices under the EU MDR. It is a proactive process that collects and evaluates clinical data on the safety and performance of a medical device in normal use. According the MDR Annex XIV Part B, PMCF should run on a continuous basis throughout the entire lifetime of a device.

Post-Market Clinical Follow-up has been an important component of medical device regulatory frameworks since the introduction of the Medical Device Directive (MDD). However, the introduction of the MDR has elevated the importance of PMCF and, with very limited exceptions, it now applies to all medical devices regardless of risk class. It is vital that medical device manufacturers have a solid understanding of PMCF requirements under the EU MDR regulatory framework.

What are the objectives of Post-Market Clinical Follow-up (PMCF)?

According to Annex XIV Part B of the MDR, overall objectives of PMCF are to collect and evaluate clinical evidence to assess the safety and performance of a medical device when used as intended. Specific objectives for PMCF under the MDR include:

  • identifying and investigating residual risks associated with use of the device
  • Contributing towards the update of Clinical Evaluation
  • Detecting any emerging risks and previously unknown side-effects
  • Confirming the overall safety and performance of the medical device in normal use
  • Identifying systematic misuse of the device and its impact on safety and performance

PMCF system design should be documented in a PMCF Plan and results must be collated in a PMCF evaluation report that forms part of the Clinical Evaluation Report (CER) for the device.

PMCF systems must be designed to accommodate the characteristics, target patient and user population, risk classification and complexity of the subject device, meaning that experience in designing clinical investigations is vital in ensuring suitability for purpose.

Design considerations for PMCF under the MDR

Manufacturers should adopt a strategic approach when designing a PMCF system to meet MDR requirements, often meaning that dedicated types of clinical investigation are used to meet the full range of requirements. Most ‘standard’ clinical investigations collect data only for a limited time and on a limited patient population, meaning that they would fail to meet PMCF requirements for longitudinal data collection throughout the entire lifetime of a device.

PMCF systems under the MDR should be designed to produce Real World Evidence (RWE) on device performance in normal use. Real World Evidence is well-suited to meeting the requirements of MDR PMCF because it:

  • Captures data from a study population that represents the entire population normally exposed to the device
  • Is non-comparative, focusing only on the safety and performance of the subject device rather than making comparisons between different devices
  • Does not involve experimental exposure; rather, it studies the use of a device that is already CE-marked and seeks to confirm or refute that it meets the necessary safety and performance requirements.
  • Recruits an unlimited number of patients over time and runs indefinitely
  • Is conducted at all types of clinical site and does not select for centres of excellence of other sites that may be unrepresentative or positively biased towards better results

Several categories of study design are capable of generating Real World Evidence of the required standard, with a medical device registry being the most versatile and powerful design. For lower-risk or consumer devices, a PMCF survey can be an effective and low-cost strategy.

Well-designed Post-Market Clinical Follow-up systems are heavily influenced by the findings of Risk Management, incorporating a design that ensures the ongoing collection of data to demonstrate benefit-risk acceptability throughout a device’s presence on the market.

PMCF clinical investigations - documentation and considerations

Clinical investigations (including medical device registries and surveys) must adhere to all legislative requirements related to the performance of medical research. Specific requirements for designing, conducting and reporting clinical investigations are documented in MDR Annex XV. Investigations must also conform with GDPR requirements on data collection and should meet the standards of clinical investigation conduct outlined in ISO 14155:2020 and GCP guidelines.

For all PMCF investigations, documents should include:

  • A Clinical Investigation Plan (CIP) or protocol that outlines how the study must be conducted
  • An Investigator’s Brochure that specifies responsibilities for the principal investigator at each clinical site
  • A patient information leaflet and consent form that ensures patients are fully informed and documents the process of informed consent

Furthermore, consideration must be given to how data will be collected and stored. Many manufacturers opt for eCRF and ePRO systems that facilitate secure data collection and storage from any internet-enabled device.

What are the requirements for developing a Post-Market Clinical Follow-up Plan?

Creating a suitable PMCF Plan requires a combination of regulatory experience, clinical expertise, and familiarity with relevant legislation and guidelines. Although Annex XIV Part B of the MDR outlines the substantive requirements of PMCF systems, being aware of and working with appropriate supporting guidelines can be of great assistance in producing an MDR-compliant PMCF strategy.

One such guideline is MDCG 2020-7 that provides a template for producing MDR-compliant PMCF Plans. It also contains guidance on structuring PMCF objectives and helps ensure that PMCF design incorporates the full range of elements required for MDR compliance.

Post-Market Clinical Follow-up

Additionally, the MEDDEV range of guidelines can be invaluable in meeting the requirements of the MDR. The relevant guideline for PMCF is MEDDEV 2.12/2 rev 2. This MEDDEV guideline covers a range of topics including:

  • When a PMCF study is indicated
  • What is required in a PMCF study
  • How to use study data
  • The role of Notified Bodies in working with PMCF data

MEDDEV 2.12/2 rev 2 was produced in reference to requirements under the out-going Medical Device Directive MDD 93/42/EC and has not yet been updated to meet the specific requirements for PMCF imposed by the MDR. Nonetheless, it serves as a very useful starting point in designing a PMCF strategy.

Refining the guidance in MEDDEV 2.12/2 rev 2 into an MDR compliant PMCF strategy requires clinical expertise, an understanding of how to drive subject recruitment at clinical sites, and detailed familiarity with the MDR requirements for designing clinical investigations in Annex XV. It also necessitates a high level of understanding of handling subject data to meet the obligations imposed by GDPR, and construction of a secure data handling and storage system.

How does PMCF relate to Post-Market Surveillance (PMS)?

Post-Market Clinical Follow-up

PMCF is a component of Post-Market Surveillance (PMS) and it is important to understand that the two systems, while related and inter-dependent, are not the same. An effective medical device PMS system will consist of a PMCF system that proactively and continually collects data on normal use, and a Vigilance system that gathers information relating to complaints and adverse events, and that handles FSCAs and FSNs. While PMCF will always return some data, it is theoretically possible that a vigilance system would return no data — for example, if the device worked flawlessly and resulted in no complaints, adverse events or serious incidents.

PMS, in turn, is a device-specific system that is part of the organisation’s Quality Management System (QMS) that oversees quality across full range of company activities.

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FAQs

We have compiled some of our frequently asked questions. If you'd like to know anything else about what we do, feel free to ask us a question.

  1. We can work with the majority of medical device manufacturers seeking compliance of their devices in accordance with Medical Device Regulation (EU) 2017/745, including both hardware and software devices. We also offer a free, no-obligation consultation, so please feel confident about discussing your requirements with a member of our team.

  2. No. We will work with you to produce systems and to support your EU MDR compliance, but we do not conduct research ourselves. We will provide tools for you to conduct your own Post-Market Surveillance. Our range of services are designed to assist you in this matter.

  3. Yes. We adhere to the highest standards of professionalism and regard maintaining confidentiality and data security as a cornerstone of our practice. We also comply fully with the requirements of GDPR.

  4. Our medical device regulatory consulting is built around a strict quality framework and we only work with clients who share this commitment to quality. Our CEO is a medical doctor with years of experience in the medical device industry and assumes personal responsibility for every project. Our product development process integrates client feedback throughout product production, ensuring a constant focus on your needs.

  5. We work with clients of all sizes and at all stages of their regulatory compliance journey. Our team are here to help and are happy to respond to general enquiries, even if you don't feel like you know where to start. We are experts at 'tuning in' to your requirements and will guide you through the entire process. Our free MDR Compliance Guide and suite of MDR downloads stand as proof of our commitment to help you understand your obligations under the MDR.

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  7. At its core, working with the MDR is about working with clinical evidence. Whether you need to generate evidence for PMCF, analyse data for writing a CER, or build an MDR-ready PMS system, our medical experts have the clinical acumen to ensure that your clinical evidence is produced and interpreted with the highest levels of professionalism. Medical professionals work with clinical evidence all day. We bring their specialist capabilities directly to your MDR strategy.

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  9. Yes. Our unique business model allows us to scale to accommodate almost any amount of work. Many of our medical professionals remain clinically active, meaning that we have trained more than we presently need. This system allows us to have ready availability of redundant capacity that can be called upon in the event of a surge in demand. Whatever your requirements, our unique business model allows us to step in faster than any of our competitors.

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