Post-Market Clinical Follow-up Report

How to successfully create a Post-Market Clinical Follow-up (PMCF) Report which is Medical Device Regulation (MDR) compliant.

What is a Post-Market Clinical Follow-up Report?

A Post-Market Clinical Follow-up (PMCF) Report is a structured report that summarises the findings of PMCF activities conducted in relation to a medical device. The Medical Device Regulation - MDR 2017/745 - significantly elevates the importance of PMCF compared to its level of prominence under the predecessor legislation, the Medical Device Directive MDD 93/42/EC.

Detailed rules for PMCF under the MDR are set out in Annex XIV Part B. All PMCF must be conducted according to a written PMCF plan, submitted as one component of the technical documentation needed for regulatory scrutiny along with the device itself. Periodically, findings from PMCF must be summarised in a PMCF Evaluation Report, with the contents of the Report also forming part of the Clinical Evaluation Report (CER) for the device.

What should the PMCF Report contain?

Post-Market Clinical Follow-up report for the EU MDR

Although MDR Annex XIV Part B contains detailed guidance for structuring a PMCF Plan, it does not go into similar detail for the requirements of the contents of the PMCF evaluation report. This can lead to manufacturers feeling unsure as to what to include in the report.

The EU Commission produces a range of MEDDEV guidance documents intended to help medical device manufacturers meet regulatory requirements. One of these documents - MEDDEV 2.12/2 rev 2 - focuses on PMCF activities and gives some detail about requirements for PMCF Reports. Unfortunately, MEDDEV 2.12/2 rev 2 has not yet been updated to reflect changes introduced by the MDR (as of June 2020) and still references Essential Requirements and other elements that no longer apply under the new legislation.

Nevertheless, information within MEDDEV 2.12/2 rev 2 is still of value in constructing a PMCF Report. The guidance document states that the report should reach conclusions that relate back to the original objectives and/or hypotheses for the PMCF study, as specified in the PMCF plan. Therefore, a sensible structure for a Post-Market Clinical Follow-up report would relate closely to the structure of the PMCF plan, introducing findings from the investigation at relevant points.

PMCF objectives should focus on areas such as:

  • Adverse events
  • Side-effect frequency and severity
  • Systematic misuse of the product
  • Safety and performance of the device in routine use

Therefore, data relating to each of these areas generated through PMCF studies can be summarised under the appropriate heading in the PMCF Report.

The report should also contain a summary of methods used to generate the data, and information about any method alternations that may be required for future PMCF activities. An assessment should also be made as to whether PMCF activities have been sufficient to address the full range of objectives specified in the plan.

What skills are necessary to write an MDR compliant PMCF Report?

The MDR as an entity draws heavily upon requirements for the production and interpretation of clinical data. An ability to critically appraise, interpret, and apply the findings of clinical evidence is essential in working with PMCF data, as is an ability to understand and appraise the methods by which data has been generated.

Medical professionals with suitable training in the field are very well positioned to write PMCF Reports and to work with many other aspects of MDR compliance that require the handling of clinical evidence.

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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.

  6. Yes. Software as a Medical Device is an increasingly-important segment of the medical device market. We have extensive experience in building regulatory systems for medical software and offer a special application of all our MDR services for software products. We also offer unique downloads and white papers that focus specifically on Software as a Medical Device.

  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.

  8. We believe in transparency and aim to build long-term relationships with our clients. This commitment is demonstrated by our customer-focused pricing strategy. You pay a small deposit upfront, only paying the balance when the work has been completed to your total satisfaction. For higher-value projects we offer flexible payment packages on an individual basis — please contact a member of our team to find out more.

  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.

  10. Yes. We run a number of events throughout the year focusing on specific aspects of MDR compliance. We also offer a limited number of free webinars on a limited basis — subscribe to our newsletter to be notified early when we publish new events. Of course, we also have our extensive MDR Compliance Guide and free MDR downloads suite, both of which offer extensive training on all aspects of MDR compliance.

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