The new MDR compliance challenge

The new MDR compliance challenge

26th May 2021 marks the end of the transition period from the old Medical Device Directive (MDD) to the new Medical Device Regulations (MDR) 2017/745.

From this date, the MDR will be in full effect and EU-based medical device manufacturers will be required to provide updated technical documentation to meet the standards of the new legislative framework.

Across the industry, medical device companies are facing challenges in meeting the demands of the new legislative framework. Long-held claims of equivalence are no longer valid and the need to evidence every indication is placing huge demands on evidence-generation systems that are difficult to meet.

Why has the Medical Device Directive (MDD) been replaced?

Although generally robust and relatively permissive of innovation, the MDD was considered to have numerous flaws in enforcing medical device safety, reliability and general product quality, exposed by notorious incidents such as the metal-on-metal hip scandal. Legislators were compelled to implement reform.

The new MDR attempts to reduce the likelihood of future incidents of this nature by tightening the requirements for proving safety and effectiveness of all medical devices, regardless of how long the product has been on the market.

How will the industry be affected?

From an industry perspective, the most important changes are the need to provide evidence “on an ongoing basis” to support every individual indication, in parallel with the reduced capacity to claim equivalence to devices already approved for sale.

These changes mean that manufacturers across the industry face a significantly increased evidence-generation burden, meaning a potentially huge increase in cost to meet the demands for medical device compliance. In some cases, this may even challenge the commercial viability of a product.

Mantra Systems is the answer to this dilemma. We are experts at navigating the evidence-generation requirements of MDR and will ensure that you have the systems in place to meet the demands of the new legislation.

How can Mantra Systems help you?

Obtaining a medical device CE-Mark under MDR requires robust clinical evidence in the form of Real World Evidence (RWE), built from real world data (RWD). Generating RWE is difficult and resource-intensive. Our experienced specialists will work with you to design and
 develop your RWE generation system to the highest level of legal and regulatory compliance.

Our MEDDEV 2.12-based systems ensure full harmonization of
 data collection standards across multiple locations in full adherence to GDPR and all relevant ISO standards.

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Our unique MDR guidance resources are written by our medical experts and free to use. They cover all aspects of the new Medical Device Regulation.

Who we work with

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.

  • It was a pleasure working with you. We are completely satisfied with your service and look forward to working with you again.

    CEO, EU medical software company
  • Your service surpassed our expectations and added value across our organisation. We now feel much better placed to prepare for the MDR.

    Chief Executive, MedTech pre-start
  • A comprehensive, detailed and highly professional service.

    Regulatory Manager, UK device manufacturer
  • International

    We work with medical device manufacturers based in the UK, Europe, the US and Asia, developing MDR strategies for both physical devices and software as a medical device.

  • Diversified

    Working with us gives you access to our growing international team of MDR-trained healthcare professionals from a wide variety of clinical backgrounds.

Read more about our team and philosophy

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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