The MDR Post-Market Surveillance and Vigilance process

Learn the process of Vigilance within Post-Market Surveillance when monitoring medical device safety under the Medical Device Regulation.

What is medical device Vigilance and how does it relate to Post-Market Surveillance?

Medical device Vigilance is the process of establishing and running a system to collect and report data on serious incidents, Field Safety Corrective Actions (FSCAs), and the monitoring of trends of expected side-effects. It is a reactive process that is a crucial element of all Post-Market Surveillance (PMS) systems under the MDR.

Rules for Vigilance are set out in Articles 87 - 90 of the MDR.

How does Vigilance differ from Post-Market Surveillance and PMCF?

MDR Vigilance

PMS, Vigilance and Post-Market Clinical Follow-up (PMCF) are easy to confuse because they all concern the collection of data on the safety and performance of CE-marked medical devices. However, while complementary and inter-dependent, they are not all the same and it is important to understand both how they differ and how they relate to one another.

PMS is a broad system that encompasses both Vigilance and PMCF. It is the overall process for monitoring and reacting to medical device performance following release onto the market.

PMCF concerns the proactive collection and analysis of clinical data through the generation of Real World Evidence (RWE) on the safety and performance of the device in normal use.

Vigilance, by contrast, requires a reactive system that is capable of collecting information in the event of a serious incident, complaint, or adverse event.

Therefore PMCF and Vigilance are components of a PMS system, which describes an overall strategy for monitoring medical device performance after release onto the market.

How is an MDR Vigilance plan developed?

A MDR Vigilance plan must be set out as a component of the PMS plan required by Article 83.

The Vigilance plan must include methods for:

  • collecting data on serious incidents
  • distinguishing serious incidents from expected side effects
  • analysing serious incidents and procedures for escalating to competent authorities
  • receiving and analysing complaints
  • compiling data on trends

Article 89 requires that the Vigilance plan must describe a process for following up on serious incidents. The follow-up process must include:

  • An investigation on the facts
  • A risk assessment
  • Communication with notified body and competent authority
  • Provision of devices for examination “as is” without making any changes to them.

The Vigilance plan must also include a method for reporting significant data obtained through the Vigilance system to regulatory authorities.

What are the requirements for MDR Vigilance?

MDR Vigilance must satisfy the requirements in Articles 87 - 90 of the MDR. The system must be outlined in technical documents that form part of the portfolio required by Annex II MDR.

Manufacturers are required to report serious incidents to competent authorities as soon as a causal relationship to the device has been established, and absolutely within the following time frames:

  • no later than 15 days after most serious incidents
  • no later than 2 days post incident if it represents a serious threat to public health
  • no later than 10 days post incident in the event of a death
  • it is permissible for manufacturers to submit a partial report initially in order to meet these deadlines.

The document MEDDEV 2.12-1 “Guidelines on a medical device Vigilance system” published by the European Commission provides detailed guidance on constructing an MDR-compliant Vigilance system.

How MDR Vigilance is different to MDD Vigilance?

MDR Vigilance is far more extensive than Vigilance under the MDD and is better differentiated from PMS. In many ways, the additional detail within the text of the MDR relating to Vigilance, compared with the incomplete description in the MDD, is a real benefit to manufacturers — under the MDR, expectations and requirements are far more clearly defined and analysing whether expectations have been met is easier and more transparent.

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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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