Real World Data

A detailed look into the contribution of Real World Data (RWD) to medical device compliance under the EU Medical Device Regulation.

What is Real World Data?

Real World Data (RWD) is clinical data derived from real world use of a medical device on a varied patient population. RWD differs from data generated in standard clinical investigations because it is generally observational rather than interventional — i.e. RWD is generated when a population who would anyway be exposed to the medical product is simply observed, rather than performing a specific intervention for the sake of the study.

RWD is less ‘clean’ than standard clinical data but generally reflects a more heterogenous patient population that better reflects the ‘true’ population exposed to the medical product in the real world. Although arguably more difficult to generate and interpret than other forms of clinical data, RWD has become progressively more important under modern regulatory systems for drugs and medical devices.

The Medical Device Directive MDR 2017/745 requires the “proactive collection and evaluation of clinical data” on the safety and performance of all medical devices throughout the entire lifetime of the medical device. Satisfying this requirement requires manufacturers to develop a Post-Market Clinical Follow-up (PMCF) system that generates some form of RWD.

What are the sources of Real World Data?

RWD can be generated from several different sources, ranging from very basic data sources to complex systems of data collection.

Patient surveys are a simple source of RWD that is simple to implement. Patients simply answer a range of basic questions after exposure to a medical device and the data is accumulated and analysed. Although simple, in the absence of appropriate controls a survey system is inherently prone to bias since operators could easily choose the “best patients” to include in a survey.

Retrospective cohort reviews are a more sophisticated source of RWD. After obtaining appropriate permissions, patient records could be analysed to obtain information about the safety and performance of a medical intervention that took place in the past, meaning that the review itself cannot directly influence results. However, this method is again susceptible to selection bias unless controls are in place to ensure that investigators select patient records that truly reflect the real patient population, rather than favourable subsets.

Prospective data registries, done properly, are a very robust source of RWD. An appropriately designed medical device registry will collect data on the safety and performance of a medical device prospectively and continually, fulfilling the requirements for PMCF in Annex XIV Part B MDR. A medical device registry requires a study protocol that outlines how the data will be collected and that ensures consistency across multiple clinical sites. It should also outline requirements for ensuring that data sets are complete and compliant, and set out methods for analysing the data in a scientifically robust manner.

How is Real World Data analysed?

RWD comprises only the raw data itself - the next step is to apply clinical acumen to analyse and interpret the data in order to understand what it tells us about the safety and performance of a device. The ‘message’ derived from analysing and interpreting RWD is known as Real World Evidence (RWE) — the analysed proof of how a device performs during conditions of normal use.

Interpreting and analysing RWD requires clinical acumen and a scientific methodology. It is made easier and more productive if the need for the data to be interpreted in this way has been accounted for in the design of the study that generated the data. This, in turn, is another argument in favour of medical device product registries that can be designed ‘from the ground up’ by those experienced in the field.

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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.

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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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