EU regulators may delay MDR enforcement. Out of the woods?

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 COVID-19. 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 Medical Device Regulation (EU) 2017/745 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 and read our White Papers to get an overview of 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.
  3. Re-visit your PMCF Plan — Whatever your existing strategy for generating PMCF data, a well-designed PMCF Study or Survey 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. When 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.

Related articles

  1. Achieving MDR Compliance for Class I medical devices

    How to achieve MDR Compliance for Class I medical devices

    We outline a strategy for the regulatory compliance of Class I medical devices.

    Sandra Gopinath Sandra Gopinath
  2. Systematic Literature Review and Clinical Evaluation

    Systematic Literature Review & Clinical Evaluation

    We help to demystify the process of systematic review of literature for Clinical Evaluation.

    Sandra Gopinath Sandra Gopinath
  3. Literature Reviews for medical devices and what to know before you start

    Literature Reviews for medical devices - what to know before you start

    We explain what you should know before beginning a Systematic Literature Review for your medical device.

    Sandra Gopinath Sandra Gopinath
  4. Five useful resources when writing a medical device CER

    Five useful resources when writing a medical device CER

    We outline five of the most useful and trustworthy Clinical Evaluation Report writing resources.

    Dr Victoria Cartwright Dr Victoria Cartwright
  5. Avoid pitfalls when writing a Clinical Evaluation Report

    Five common pitfalls when writing a Clinical Evaluation Report

    We illustrate five pitfalls when writing CERs and give you some tips to overcome them.

    Dr Paul Hercock Dr Paul Hercock
  6. How to make a medical device equivalence claim under the MDR

    Five tips for making a medical device equivalence claim under the MDR

    We'll show you what to keep in mind with regards to equivalance and Clinical Evaluation.

    Sandra Gopinath Sandra Gopinath
  7. Keeping medical devices in market and maintaining CE-marks - a guide to effective data collection

    Keeping medical devices in market & maintaining CE-marks

    The 4 golden rules to drive regulatory compliance with PMCF and vigilance data collection.

    Dr Paul Hercock Dr Paul Hercock
  8. How PMCF goes beyond simple compliance - improving products and engaging customers

    How PMCF goes beyond simple compliance

    The wider benefits of a well-designed PMCF system include improving your products and your relationship with your clients.

    Dr Paul Hercock Dr Paul Hercock
  9. PMCF systems for medical devices

    Why you'll almost certainly need a PMCF system for your medical devices

    We tell you what to be aware of under the EU MDR regarding PMCF and your medical devices.

    Dr Paul Hercock Dr Paul Hercock
  10. Our online PMCF Checker shows if your medical device requires a PMCF system

    Does my medical device need a PMCF system for MDR compliance?

    Answer 10 quick questions to check whether your medical device requires a PMCF system.

    Matthew Stinson Matthew Stinson
  11. Ensure medical device regulatory compliance of your devices through Brexit

    The impact of Brexit on medical device regulatory compliance

    How to ensure regulatory alignment of your devices in the territories affected by Brexit.

    Dr Paul Hercock Dr Paul Hercock
  12. Increasing data entry compliance in PMCF studies

    Increasing data entry compliance in PMCF studies

    5 methods every medical device manufacturer should know to improve their Post-Market Clinical Follow-up studies.

    Dr Paul Hercock Dr Paul Hercock
  13. Why medical doctors can drive MDR compliance

    Why medical doctors can drive MDR compliance

    Working with the MDR requires knowing how to work with clinical evidence. Medical doctors are perfectly positioned to meet this requirement.

    Dr Victoria Cartwright Dr Victoria Cartwright
  14. clinical investigator for pmcf eu mdr compliance

    Ensuring that clinical investigations work in practice

    How can medical device manufacturers ensure valid clinical investigations when access to medical expertise remains limited?

    Dr Paul Hercock Dr Paul Hercock
  15. Coronavirus and medical device regulations

    Relaxing medical device regulatory requirements during a healthcare crisis

    During the coronavirus pandemic, how far should we go when relaxing medical device regulatory requirements?

    Dr Paul Hercock Dr Paul Hercock
  16. EU flag

    A proposal to delay the EU MDR gets approved

    A vote in the European Parliament has decisively approved a delay to full implementation of the EU's MDR by one year, allowing the medical device industry to prioritise its Covid-19 response efforts.

    Richard Jones Richard Jones
  17. The new MDR compliance challenge

    The new MDR compliance challenge

    Across the industry, medical device companies are facing challenges in meeting the demands of the new Medical Device Regulations (MDR) 2017/745 framework.

    Dr Paul Hercock Dr Paul Hercock
  18. Sources of Real World Evidence for MDR compliance

    Sources of Real World Evidence for MDR compliance

    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.

    Dr Paul Hercock Dr Paul Hercock

More articles

Do you need help with your MDR strategy?

Talk with us

Hello there…