EU MDR Compliance Guide

How to transition from the Medical Device Directive to the new Medical Device Regulation (EU) 2017/745 for EU MDR Compliance.

What is 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 (SPRs).
  • 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.

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:

  • 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 General SPRs, 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.

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