How to write a comprehensive PMCF Plan for medical devices under the Medical Device Regulation (MDR)

A PMCF Plan is a paramount technical document that highlights a method for conducting Post Marketing Clinical Follow Up on a medical device

The medical device field is always evolving and post-market clinical follow-up (PMCF) has become a critical area of focus for manufacturers. A PMCF Plan is a paramount technical document that highlights a method for conducting Post Marketing Clinical Follow Up on a medical device. A PMCF Plan must be submitted for regulatory approval of devices under the EU MDR as a component of the MDR Annex II technical documentation. MDR Annex XIV Part B requires that a PMCF Plan must provide a detailed summary of a method that will:

  1. Prove safety and performance of the device throughout its expected lifetime
  2. Identify previously unknown side-effects
  3. Monitor the rate and severity of known side-effects
  4. Identify and analyse any emergent risks
  5. Ensure continued benefit-risk acceptability
  6. Identify any systematic misuse or off-label use
  7. Writing a PMCF Plan is a process that draws upon expertise in technical writing and clinical investigation design.

Method to write a PMCF Plan

PMCF is an integral part of keeping the clinical evaluation current. It acts as a continuous feedback loop, providing new clinical data to refine and update the original assessment. Writing a PMCF Plan involves two stages:

PMCF system design – PMCF system must be designed to meet the needs of the subject device before a PMCF Plan can be written.

PMCF Plan structure – once designed, the PMCF system must be documented in a PMCF Plan that is structured according to MDR requirements.

PMCF system design

Operative PMCF systems are built to address risk management outcomes alongside the overall objectives for PMCF as specified in the MDR. PMCF system design should be tailored to the subject device and its associated classification and complexity. A PMCF system has to be capable of capturing data on the use of a medical device throughout its entire lifetime, meaning that many standard-type clinical investigations will not be suitable for this application.

PMCF systems can extend from simple patient or end-user surveys to formal clinical investigations and complex medical device registries that incorporate clinical and patient feedback data. All clinical investigations must adhere to MDR Annex XV requirements on design, documentation, consent and data handling, as well as external legislation such as the GDPR and standards such as ISO 14155:2020.

More and more, manufacturers are advised to develop a PMCF Plan that outlines a method for generating Real World Evidence (RWE) that provides data on real, undifferentiated use of the product in the hands of genuine users. Standard clinical investigations are usually too restrictive to meet requirements for PMCF under the MDR and will not run for a sufficient length of time to meet requirements for longitudinal data collection.

A PMCF study (or sometimes known as a ‘medical device registry’) is a sophisticated system that provides a single central repository of PMCF data captured from any number of different territories. Correctly designed, a PMCF study ensures that data is generated in a consistent manner under a universal study protocol. It also ensures adherence to wider rules and regulations including the requirements for clinical investigations in Annex XV MDR.

Clinical evidence generation systems demand specialist knowledge to design and implement. Once established, a well-designed system can pay huge dividends through ensuring ongoing availability of data to support regulatory approval of a medical device throughout its commercial lifecycle.

PMCF Plan structure

The PMCF structure closely mirrors the plan but includes the results of undertaken activities and their impact on technical documentation. It concludes with findings related to the PMCF plan and their implications for future actions. The PMCF Plan must comprehensively outline the systems and processes through which the PMCF system will function. The PMCF Plan will be subject to regulatory review from Notified Bodies and other regulatory authorities alongside other technical documentation.

A well-written PMCF Plan should include at least:

  • Details of general methods to be applied, e.g. gathering clinical data, user feedback and/or literature searching
  • Specific methods to be used, e.g. PMCF study/survey/registry
  • Rationale for selected general and specific methods
  • A reference to relevant parts of the Clinical Evaluation Report (CER) that contain a summary of PMCF data, an appraisal of the PMCF system, and results of data analysis.
  • Specific objectives addressed by PMCF
  • Evaluation of clinical data from equivalent/similar devices, if relevant
  • Reference to any harmonised standards used in developing the PMCF Plan
  • Timescale of PMCF activities

Determining Enough Evidence under EU MDR

PMCF is the process of proactively and constantly collecting clinical data in order to demonstrate that a CE-marked medical device’s safety and performance is in line with expectations.

The Medical Device Regulation (MDR) greatly improves the importance of PMCF compared to the MDD. A detailed set of requirements for the design and conduct of PMCF activities is outlined in MDR Annex XIV Part B. A specific requirement is that all manufacturers document a PMCF Plan to detail the process that will be followed in collecting PMCF data on each of their medical devices.

It is paramount to account for all relevant laws and regulations when developing a PMCF Plan. In particular, the General Data and Performance Regulations (GDPR) establishes a strict set of standards for handling study subject’s clinical data, and the PMCF Plan should establish procedures for ensuring that the requirements of this Regulation are adhered to.

Furthermore, it is important to consider whether PMCF activities may require ethical approval before data collection can commence. Requirements for ethical approval vary between different EU Member States so it is pivotal to understand local requirements and ensure that the PMCF Plan incorporates procedures for meeting obligations.

Key considerations of PMCF under MDR

MILO Healthcare has clear understanding on the expectation of the notified bodyies whether your device requires a PMCF plan beyond the minimum literature search involves careful consideration of several factors:

  1. Adequacy of existing clinical evidence: Evaluate the existing data for each device indication, ensuring it sufficiently demonstrates safety and efficacy throughout the intended lifespan.
  2. Device innovation: For novel devices with limited pre-market clinical data, PMCF plays a crucial role in gathering real-world experience and refining the clinical evaluation.
  3. Risk classification: Higher-risk devices naturally require more robust PMCF activities to ensure ongoing safety monitoring.
  4. Anatomical location: Devices used in sensitive or critical anatomical areas may necessitate more intensive PMCF to mitigate potential risks.
  5. Intended population: Devices used by vulnerable populations, such as children or pregnant women, often require additional data collection through PMCF to ensure their safety and suitability.

Equally, the MDR places particular emphasis on clinical evaluation gap assessment for legacy devices. This involves a detailed analysis of the existing clinical data to identify any gaps or uncertainties that necessitate PMCF activities. The rationale for any PMCF plan or exemption must be clearly documented in the technical documentation for regulatory review.

Knowing the potential benefits of MILO ePRO post-marketing in medical device investigations:

  • Compliance with all relevant FDA, MDR, and GDPR requirements.
  • Ease of use for subject.
  • Operational equivalence across all likely mobile devices.
  • Full access to the feature set underlying MILO platforms.
  • real-time patient data collection.
  • user-friendly design.
  • These are some of many benefits brought by using our Platform. MILO ePro isn’t just a tool; it’s a game-changer for clinical trials.

How to report the outcomes of the patients?

Patient engagement is crucial to the success of any clinical study. MILO’s ePro approach emphasizes user-friendly design. Patients submit their results on the MILO DCT app with simplicity and intuitiveness while ensuring the security of their data.

There are two ways in which the patient can directly report outcomes via ePRO. Firstly, subjects can report during a site visit where staff can easily initiate a subject session to allow them to complete a questionnaire, or the subject can log in from home with a unique username and password. If the subject is reporting from home, they might be using a dedicated device supplied by the Sponsor or they may be using their own device loaded with the MILO APP (available on IoS and Android).