Sources of Real World Evidence for MDR compliance

Sources of Real World Evidence for MDR compliance

There are multiple ways to generate Real World Evidence (RWE). At Mantra Systems our objective is to make sure that our clients choose the method of real-world data harvesting that is right for them. This article outlines some of the different methods available for collecting real-world data and producing RWE.

The choice of real-world data collection method is often driven by a combination of factors. Some of the factors to consider include:

  • market sector
  • availability of external data sources
  • product type
  • available company resources
  • time and criticality

Unfortunately, the method chosen by medical device manufacturers often isn’t the best one for their needs. A poor choice of RWE generation method tends to lead to an accumulation of problems over time, as weaknesses of either collection method or the data itself tend to compound as data collection is ongoing.

Manufacturers may also find that compliance of data collection by investigators is far below requirements if insufficient attention is given to the choice of data collection method. Ultimately, the wrong choice leads to both time and money being wasted and leaves a critical problem remaining to be solved.

Differing market sectors

Some market sectors are extremely fortunate in this regard as there are already a number of external or nationalised registries that collect data on the performance of multiple products within a sector. For example, the National Joint Registry in the UK collects real-world data on the performance of joint replacement implants. This is a rich source of data that companies can access to compile evidence for regulatory submission, and has the advantage of being consecutive, non-selective, and objective (ie administered by an external agent rather than the manufacturer of the product in question).

Other market sectors are not so fortunate. In the absence of such nationalised registries, manufacturers must find other ways to generate RWE.

For some products, a simple patient survey may suffice, perhaps collecting outcome measures such as EQ-5D-5L or pain VAS in return for a modest reward. This will suffice for lower risk devices where the level of scrutiny of RWE is comparatively light. The priority is to collect incidences of Adverse Events and, ideally, some limited functional outcomes data.

Common problems

For products in higher risk categories (Class IIb and III under the MDR), a more robust system of real-world data collection will be required.

In some cases it may be possible to buy data from a commercial external database administered by a data provider. This has the advantage of avoiding the need to build a new data collection system “from scratch”, however there are numerous disadvantages to this approach.

Firstly, the manufacturer will have no control over which data points are collected, meaning that they have no ability to tailor the data collected to the needs of either themselves or their customers.

Secondly, the manufacturer has no control over HOW the data was collected — in the era of GDPR and other important data control measures, the manufacturer will need to provide justification for the data collection methods employed in generating their RWE.

Thirdly, the data remains owned by the data provider, meaning there is no opportunity to make multiple uses of the same data at different times without paying repeatedly to extend licenses.

Perhaps most importantly, such data is almost always retrospective. Regulators increasingly require prospective data to support regulatory submissions, and the inherent inflexibility of retrospective datasets may often mean that manufacturers need to seek alternative or ancillary data to maintain regulatory approval over time.

A solution

For these reasons and many others, a dedicated medical device registry offers numerous advantages. One particular advantage of a dedicated product registry is the ability to record data in real-time. In an increasingly digital world, this is a huge advantage of such a data collection system. Dedicated product registries are also prospective.

Our dedicated registry building service will ensure that you have the most robust, adaptable, personalised and appropriate Real World Evidence generation system for your individual requirements. Our team of experts will work with you to build the an observational device registry that will meet your RWE-generation needs both now and in the future.

We also have the necessary experience to create a registry that offers value to your customers, allowing you and your customers to become strategic partners in both medical device scrutiny and data generation, the uses of which will stretch far beyond mere regulatory compliance.

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Our clients come from across the industry and range from pre-start businesses to stockmarket-listed multinationals. We also have key strategic partners based in the UK and Denmark.

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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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