Coronavirus and medical device regulations

Relaxing medical device regulatory requirements during a healthcare crisis

A healthcare crisis such as the Covid-19 pandemic means that adaptations must be made across the medical device industry. Manufacturers, regulators, and product users are being asked to do more with fewer resources, meaning that processes must be streamlined in order to meet demands.

One step that has been considered is a partial relaxation of regulatory obligations to enable more products to be brought to market. The one-year delay to full implementation of the MDR arguably stands as evidence that regulators understand the difficulties that manufacturers are currently facing. Other proposed measures include allowing re-use of single use devices to ensure ongoing availability of critical products.

In the event of a global health crisis, the Medical Device Regulations MDR 2017/745 allows for a partial step down from full regulatory enforcement. MDR Article 59 describes a procedure for emergency derogation from standard conformity assessment processes in the event of a public health emergency. Article 59 enables Competent Authorities to allow normal conformity assessment procedures to be bypassed for devices that are deemed essential in responding to the healthcare emergency. Unsurprisingly, in the context of the current crisis, Article 59 applications to the MHRA have been very numerous.

While it is a priority to ensure that life saving products are made available to staff and patients as quickly as possible, it is also vital that the safety and performance of medical devices is subject to the appropriate level of scrutiny. A balance must be found and the industry must ensure safety as well as product availability. The medical device market is one of the most tightly regulated sectors in the world for good reason — unsafe or ineffective medical devices could cause far more problems than they solve.

We believe that conformity derogation procedures have an important role to play in securing device availability at times of crisis. However, we also believe that they should very much be the exception and that normal medical device regulatory processes should continue to be the default position. Product safety should take priority given the vast range of devices already available on the market.

Understandably, all medical device manufacturers are keen to reduce time and money spent on regulatory processes. However, the best approach is to work with a regulatory professional who will advise on the most efficient route to medical device certification. Working with a services provider who is an MDR expert will ensure than your devices are made available quickly, and that their regulatory approval status is protected well into the future.

Mantra Systems brings medical expertise to MDR compliance. Our team of expertly-trained medical professionals deliver MDR support services focused on clinical evidence, clinical evaluation, PMS, PMCF and clinical investigation design. Consult with a member of our team to discuss your requirements.

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Our clients come from across the industry and range from pre-start businesses to stockmarket-listed multinationals. We aslo 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 in future.

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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 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 services are 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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