EU regulators may delay MDR enforcement

Out of the woods? EU regulators may delay MDR enforcement

It has been extensively documented that much of the medical device sector was facing challenges in being ready to meet the 26th May 2021 MDR implementation date. Sweeping regulatory changes and a lack of notified body capacity meant that many providers felt ill-prepared even before the emergence of the COVID-19 pandemic. Factor in the disruption caused by the coronavirus outbreak and it should be no surprise that many were calling upon regulators to delay full implementation of the MDR.

Reports now suggest that these calls may be answered.

While this would be welcome news for many, what would a delay mean in practice? To what extent can preparations for EU MDR be put on ice?

Although it is sensible in the short-term to focus on dealing with the exceptional pressures caused by the coronavirus outbreak, we believe that the importance of preparing for MDR enforcement must not be entirely displaced. This possible delay calls for a new wave of focus, using the extra time productively to gain broader advantages from being ready for the MDR.

Up until now, many companies across the industry were trying to do “just enough” to scrape through the 26th May deadline, viewing the MDR as a challenge rather than an opportunity. Our view all along has been that, with the correct approach, the EU MDR presents a unique opportunity for exceptional companies to prove the worth of their products and their wider organisation. Any implementation delay simply magnifies that opportunity.

Wisely investing the extra time to re-evaluate and partly re-purpose your existing MDR transition strategy could yield opportunities to make better use of clinical data, build relationships with clinical sites, and find solutions to compliance challenges that can better serve the needs of your wider organisation. With the correct strategy, regulatory departments have the opportunity to spearhead the development of new publications and to safeguard the competitive position of the company against competitors who have taken their eye off the MDR ball.

So what specifically can be done to make best use of an extra year? Here are 5 tips:

  1. Enhance your understanding of the MDR as an instrument. At 175 pages, the MDR is a challenging instrument to work with. Very few in the industry would profess to have a thorough understanding of the legislation itself, yet it holds all the answers to ensuring MDR compliance of your products both now and in the future. Download our white paper or register for one of our live seminars to learn everything you need to know about the MDR.
  2. Perform a Gap Analysis. Go back to basics and use Annex I MDR to re-evaluate how robustly your existing clinical data portfolio demonstrates conformity with the general safety and performance requirements that are relevant to your products. Engage with our team of specially trained medical professionals to bring an expert medical opinion to your Gap Analysis.
  3. Re-visit your PMCF plan. Whatever your existing strategy for generating PMCF data, a well-designed medical device registry offers a host of advantages in data robustness, minimising bias, ensuring data continuity and building relationships with clinical sites.
  4. Take stock of your technical documentation. Use the time to conduct an audit of your technical documents and compare your portfolio with the requirements in Annexes II and III of the MDR. Contact us for help in updating your documents to the required standard.
  5. Write a CER, even if not yet due. Compiling a CER to the requirements of the MDR rather than the MDD is a fantastic way to uncover any gaps in your Clinical Evaluation. It’s about much more than just the document — identifying any areas of deficiency now leaves plenty of time to address them before the revised MDR implementation date. Our medical specialists are experts at writing CERs and performing Clinical Evaluation of medical devices.

The likely delay to full MDR implementation is a great opportunity to take stock, zoom out and re-assess your regulatory strategy. A sensible investment of time now will ensure you are well ahead of the competition when the MDR does come into full force. This is much more than just a box-ticking exercise — done properly, it helps ensure that your devices can continue to be where they are needed most — in the hands of your customers, providing better and safer healthcare for patients everywhere.

Out of the woods? Not quite, but the regulators might have pruned the trees a little.

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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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