EU MDR Compliance Guide

How to achieve EU MDR Compliance by transitioning from the Medical Device Directive to the new Medical Device Regulation (EU) 2017/745.

What is EU MDR compliance?

EU MDR compliance

In order to gain regulatory approval for any medical device it will be necessary for manufacturers to demonstrate MDR compliance of the devices they make, as well as that of systems and processes that evaluate and document performance of the device following its release onto the market.

MDR Compliance is achieved by demonstrating conformity with all relevant requirements of the MDR. In general these requirements include:

  • Developing a medical device according to established safety and quality processes.
  • Demonstrating conformity with the Annex I General Safety and Performance Requirements (GSPRs).
  • Producing a dossier of Technical Documents according to requirements in Annex II and Annex III, and ensuring that the content of those documents is correctly structured and all claims evidenced.
  • Planning, documenting, implementing, and maintaining a Quality Management System (QMS) and Post-Market Surveillance (PMS) system.
  • Documenting and implementing a Risk Management process.
  • Undertaking a Clinical Evaluation of every medical device and documenting the evaluation in a Clinical Evaluation Report (CER).
  • Having a Person Responsible for Regulatory Compliance either within the organisation or permanently at its disposal.

Rules for assessing MDR Compliance differ according to the risk class of the device. For Class IIa, IIb and III devices a Notified Body will be required to perform an assessment of the device, associated technical files, and surveillance, quality, and risk management systems to determine whether MDR Compliance has been achieved. Although Class I devices do not normally require involvement of a Notified Body, it is still necessary to produce technical files and develop appropriate quality, Risk Management and Post-Market Surveillance (PMS) systems to monitor device performance.

MDR compliance is demonstrated by the application of a CE mark, either self-applied in the case of Class I devices, or following receipt of a certificate of conformity from a Notified Body for devices in other risk classes.

Can Mantra Systems help you?

Complete PMS systems for your medical devices

Post Market Surveillance services for EU MDR compliance of your medical devices.

  • Full / modular service
  • Tailored development
  • Ongoing maintenance
  • Technical documentation

Find out more about our Post-Market Surveillance service

How to achieve MDR compliance?

The most effective way to achieve MDR Compliance is in two phases:

  1. Understand the MDR in detail
  2. Apply that understanding to build a framework that complies with requirements

It is almost impossible to achieve MDR compliance without a detailed understanding of the MDR itself. Once a sound understanding has been established, building a compliant framework becomes much more attainable.

Phase 1 — Understand the EU MDR in detail

The text of the MDR outlines all the rules and requirements that regulators will be applying to assess every medical device submission.

The Medical Device Regulation MDR 2017/745, commonly known as the MDR, is an extensive piece of legislation that represents the largest overhaul of medical device regulation in decades. Now scheduled for full implementation in 2021, the EU MDR will replace the Medical Device Directive MDD 93/42/EC and introduce a wide range of changes in the way medical devices are regulated in Europe.

The MDR describes a detailed regulatory environment that outlines rules and regulations for all aspects of developing, marketing and monitoring the performance of medical devices. It is therefore essential that medical device manufacturers develop a detailed understanding of the MDR or risk falling short of requirements.

The MDR introduces a range of changes that place a higher burden on manufacturers in many areas, including:

  • A wider definition of the term “medical device” — The scope of the MDR is wider than that of MDD meaning that some product manufacturers, such as those that make medical apps or nanomaterials, are subject to medical device legislation for the first time.
  • A much higher requirement for clinical data — This includes the need for studies to back up every claim made about a device, along with Real World Evidence (RWE) to demonstrate that devices function safely and effectively in the hands of the ‘normal user’ outside the artificial environment of clinical trials.
  • Limitations on the concept of equivalence — Under MDD it was possible for manufacturers to claim that their device was ‘equivalent’ to a related device already approved for sale; they could then “piggy back” on the clinical evidence portfolio of that equivalent device without needing to produce their own. Under MDR, the ability to do this has been significantly constrained.

It’s also important to keep updated with harmonised standards such as ISO standards, compliance with which will lead to a presumption of compliance with the MDR in that area. In addition, the various MEDDEV guidelines provide guidance in structuring and performing a range of MDR compliance activities.

Phase 2 — Apply your understanding to build an MDR compliance framework

A thorough understanding of the MDR allows you to use the information within the Regulations, along with guidance from harmonised standards and MEDDEV guidelines, to begin constructing MDR-compliant systems and processes. Many processes that achieve MDR compliance follow the same structure, namely:

Quality Management System process for the EU MDR
  • Establish
  • Document
  • Implement
  • Maintain
  • Keep up-to-date
  • Continually improve

Applying this process to Quality Management Systems, Post-Market Surveillance Systems, Risk Management processes and Clinical Evaluation will help ensure that information gathered during the “Implement” phase is worked back into the design of the systems and responded to appropriately.

Even with a thorough understanding of the MDR, building compliant systems can be challenging. For example, demonstrating conformity to the GSPRs, developing PMCF procedures within a PMS system, and performing Clinical Evaluation all involve the design, documentation, implementation and conduct of clinical investigations. Performing and interpreting clinical investigations requires medical insight that many medical device companies do not have available in-house.

Clinical evidence in the EU MDR

Clinical evidence has assumed an even greater level of importance in demonstrating device safety and performance under the MDR than it did under the MDD. MDR compliance will require a comprehensive clinical evidence portfolio that demonstrates:

  • Safety and efficacy for every individual indication in normal use
  • Conformity to the Annex I General Safety and Performance Requirements
  • A thorough Clinical Evaluation accounting for all relevant clinical evidence whether favourable or unfavourable
  • Acceptability of benefit-risk ratio
  • Acceptable levels of side-effects and adverse events
  • Adequate responses to serious incidents

Meeting these requirements will necessitate:

  • Performing structured literature reviews, critiquing sources, and performing a scientific analysis and report of findings
  • Designing clinical investigations in line with Good Medical Practice, Annex XV MDR, and the GDPR
  • Applying different types of clinical investigation to different purposes
  • Understanding how to work with clinical sites to enhance data collection compliance
  • Ensuring requirements for patient consent and ethical approval are met
  • Implementing well-structured Vigilance systems and applying a medical interpretation to the results

Furthermore, regulatory staff need to have a good working relationship with marketing departments and sales staff, since all promotional claims made by the manufacturer must be backed by clinical evidence.

It is not enough simply to produce clinical evidence; the methods by which such evidence is produced must also be compliant with expectations. Clinical investigations must minimise the potential for bias, be adequately powered, represent the population normally subject to the device, and employ appropriate methods of statistical analysis in interpreting and applying results.

Methods must be outlined in a range of technical documents that must be submitted for regulatory scrutiny. Annex XV MDR outlines that necessary documentation includes a Clinical Investigation Plan and investigator’s brochure for each clinical investigation, as well as any other information deemed necessary to ensure proper conduct of the study and scientific validity of results.

It should be clear that designing clinical investigations intended to be part of any MDR compliance strategy is a specialist task that requires extensive clinical, regulatory, legal and medical device industry experience. Many companies will fail to produce clinical evidence of the standard required because they do not have access to such expertise in-house, threatening the regulatory approval status of their products.

How is the need to demonstrate MDR compliance affecting the industry today?

Although the MDR is not yet in full force, many manufacturers from all sectors of the industry are facing challenges in meeting the requirements for EU MDR compliance. Meeting the requirements of the MDR in time will require many manufacturers to implement new policies and strategies well ahead of the deadline.

  • Meeting the requirements for MDR compliance by the 2021 deadline will require forward planning in order to ensure that evidence is ready for submission in time.
  • Long-held claims of equivalence may no longer be valid meaning that, in many cases, new evidence portfolios will need to be produced from scratch.
  • The need to evidence every indication is placing huge demands on evidence-generation systems that will need to be expanded or re-designed in order to meet needs.

It is estimated that nearly 80% of European medical device companies do not yet have a regulatory strategy that would be sufficient for MDR compliance. This highlights both the low level of understanding and the low level of preparedness towards MDR Compliance within the industry. Many manufacturers, without a change in approach, run a real risk of regulatory approval being removed for their products after the 2021 deadline.

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 enhancing requirements for proving safety and effectiveness of all medical devices, regardless of how long the product has been on the market.

The five most important changes you will need to know about?

  1. Broader definition of “Medical Device”. Under the MDR, diagnostic software, apps, nanomaterials and some products that specifically claim not to be medical devices are amongst those that will be caught by the Article 2 MDR definition of what is a medical device.
  2. Reduced capacity to claim Equivalence. Claiming equivalence to another medical device already approved for sale will now require full unfettered access to the technical files of that medical device - something that would appear unlikely if made by a competitor.
  3. A change to risk classification of some categories of device. Generally, where any changes have been introduced they have resulted in a higher risk classification, increasing the regulatory burden on manufacturers.
  4. Reduced Notified Body capacity. As of today only 11 Notified Bodies have gained approval to perform conformity assessments under the MDR, forming a bottle-neck and making it even more important that manufacturers develop an MDR compliance strategy well ahead of the 2021 deadline.
  5. A great emphasis on clinical evidence. More than ever before, device safety and performance, benefit-risk analysis, Clinical Evaluation and post-market surveillance will require the production of high-quality clinical evidence. This includes an increased role for real world evidence in demonstrating safety and efficacy of a device in normal use.

Call us now to discuss your MDR requirements:

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MDR Consulting

Our team of medical professionals are specialists at building the clinical evidence portfolio that you need for MDR compliance of your products.

MDR Training

Our comprehensive training services are delivered by experts and address all aspects of MDR compliance.

Who we work with

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.

    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.

Download our free Mastering the MDR White Paper — An easily digestible summary of the EU MDR

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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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