Post-Market Surveillance under the EU MDR

A comprehensive free guide to Post-Market Surveillance (PMS) of medical devices

What is Post-Market Surveillance (PMS)?

Post-Market Surveillance (PMS) can be defined as a structured process of monitoring the safety and performance of a medical device following its release onto the market. It involves the proactive collection and review of data relating to clinical experience with the device.

Effective PMS requires a combination of processes and systems that work together to develop a robust ‘picture’ of how a medical device is performing in real-world use following its commercial release.

The MDR builds upon previous requirements for PMS systems in medical devices. It requires that a Post-Market Surveillance framework is in place for all medical devices, using a design that is proportionate to risk class and appropriate for device type.

What are the MDR requirements for Post-Market Surveillance?

Post-Market Surveillance process for the EU MDR

MDR Article 83 outlines the requirements for Post-Market Surveillance systems under the new regulatory framework. Every manufacturer is required to plan, establish, document, implement, maintain and update a PMS system for every medical device. The system must be designed and documented in a PMS plan (detailed below) and then constantly updated according to a structured assessment of how well it is working and ongoing analysis of the data it has yielded.

MDR Article 83 requires that data generated by Post-Market Surveillance systems is used in specific ways; in particular it should be used to:

  • Update the benefit-risk profile of the device through contributing data about the frequency and seveity of device-related harms
  • Feed improvements to Risk Management processes
  • Update device design, Instructions For Use (IFU) and device labels to optimise device safety and performance during use
  • Form a core component of updating the Clinical Evaluation of the device
  • To identify needs for PACAs or field safety corrective actions (FSCAs)

How does an effective Post-Market Surveillance system monitor medical device safety?

Post-Market Surveillance

A well-designed PMS system will monitor the safety and performance of a medical device through two complementary domains:

  • Post-Market Clinical Follow-up (PMCF) that involves the design and conduct of clinical studies to proactively and continually assess device safety and performance
  • Vigilance systems that monitor and respond to complaints, adverse events, media reports, serious incidents and Field Safety Corrective Actions (FSCAs)

Vigilance systems can be thought of as an “ear to the ground” for any potential safety or performance concerns relating to the device. Although rare in practice, it is at least theoretically possible for vigilance systems to return no data. On the other hand, PMCF involves the continuous collection of clinical data throughout the entire clinical lifetime of the device, generating Real World Evidence (RWE) on safety and performance. In contrast to vigilance, Post-Market Clinical Follow-Up will always return some data by virtue of design.

Post-Market Surveillance systems that incorporate both arms of data collection are more robust and will more closely align with MDR requirements.

What documents must be produced in relation to MDR PMS systems?

MDR Annex III provides useful details about what technical documents must be produced in relation to Post-Market Surveillance.

All MDR PMS systems require a PMS Plan that describes in detail how the system will collect and analyse safety and performance data. A well-written PMS Plan will account for using data from a wide range of different sources including:

  • Serious incidents
  • Field Safety Corrective Actions (FSCAs)
  • Complaints
  • Databases and/or registries
  • Feedback and complaints

MDR Annex III outlines rules for constructing the PMS Plan. As a minimum the PMS plan should contain the following:

  • A documented process to collect information from the identified data sources
  • A description of methods that will be used to assess and interpret collected data
  • An explanation of the rationale used during risk analysis
  • Detail of methods for collecting and investigating complaints and analysing trends
  • Procedures for communicating with competent authorities and notified bodies
  • Methods for tracing devices following product complaints or adverse events

The output of PMS activities must be collated in a PMS output report. The format of this report varies according to the device’s risk class:

  • For Class I devices a comparatively simple PMS Report is required that simply summarises outcomes from PMS activities relating to the device.
  • For all other device classes a more detailed Periodic Safety Update Report (PSUR) must be produced with a periodicity that varies according to risk class (at least annually for Class III).

What are MedDev 2.12/1 Rev 8 and MedDev 2.12/2 rev 2? How do they relate to PMS under the MDR?

The European Commission produces a range of guidance documents, known as MedDev guidelines, in relation to medical device regulation. MEDDEV guidelines are not legally binding but are a very useful source of information when developing PMS systems and other aspects of medical device regulation.

MedDev 2.12/1 Rev 8 provides guidance on medical device vigilance systems and MedDev 2.12/2 rev 2 details guidelines for PMCF. Although neither has yet been updated (as of December 2020) to reflect changes introduced by the MDR, they are still extremely useful documents. A combination of familiarity with the content of the MedDev guidelines along with the content of relevant sections of the MDR will form the basis of an ability to develop an MDR compliant PMS system.

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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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