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A Look Inside the New EU Medical Device Regulation

We talked to our Chief Compliance Officer, Rok Hrovatin, about the new medical device regulation that is being introduced in the EU in May 2021. The MDD will be replaced with Regulation (EU) 2017/745.

A Look Inside the New EU Medical Device Regulation

Essentially, the objectives of the two regulatory acts are the same – they both aim at safe, functional devices and ensuring the risks related to their use are acceptable. Yet, for a manufacturer of medical devices the difference between the two is in how these goals are achieved and how they need to be demonstrated. These are unveiled once the MDR is studied, understood, and followed.

What are the main challenges the medical device industry is facing with the introduction of the new medical device regulations?

So, the key challenges of industry will be in (now) quick adaptation to the new rules of demonstration of compliance (i.e., conformity assessment procedures) – depending on the classification of each particular device and on the options available for a particular class. While the core of the risk-based classification of medical devices remains the same under MDR – the higher the risk, the higher the class, and the stricter requirements are imposed to medical devices – there are modifications and amendments in the classification rules themselves.

As for example, related to “medical software” a new rule, Rule 11, has been prepared. It is expected that this rule will make the path to market for most ‘SaMD’ (Software as a Medical Device) better defined, but also more challenging, for example, with increased timelines and costs.

This might have an impact on smaller companies and startups, in particular, not being aware of their obligations. In contrast, the eventual impact of the MDR will be to further protect and enhance public health by ensuring the safety and performance of SaMD throughout their lifecycle.

What are the main changes in the new European Medical Device Regulation?

There are a number of changes between the two documents, i.e. between the MDD (Medical Device Directive – 93/42(EEC) and the MDR (Medical Device Regulation (EU) 2017/745). To list just a few of them:

  • Post-market surveillance results will have to be reported on a regular basis, together with periodic safety update reporting to the European database;
    Vigilance requirements are more strict, and they bring shorter notification periods;
  • Precise definitions of stakeholders, i.e. economic operators, in the business chain are given – together with their responsibilities;
  • MDR is introducing the responsibilities of the Person Responsible for compliance with the MDR 2017/745 Medical Devices Regulation;
  • The definition of medical device has undergone slight modification and the scope of devices considered by the regulation has increased;
  • A completely new classification rule for medical software (our strong point) and amendments for some other product groups;
  • Then, linked to the risk class – there are options for conformity assessment procedures, which are simplified in a sense;
  • The role of a clinical evaluation is emphasized in general;
  • The requirements for Unique Device Identification system – improving the traceability of devices on the market;
  • More and better technical documentation is required.

If you look specifically at medical devices classification within the EU MDR, how is it different from what we are used to from MDD?

As previously noted, the core of the classification stays the same – the higher the risk, the higher the class. However, the EU MDR will contain five more rules for classification than the previous Medical Device Directive (MDD). Which are the new rules?

  • Rule 11: A new class of high-risk software has been introduced, which includes stand-alone software (software that can work offline, or is a portable application),
  • Rule 19: concerning devices incorporating or consisting of nanomaterials,
  • Rule 20: concerning inhalers,
  • Rule 21: concerning substances,
  • Rule 22: concerning active devices with a diagnostic function.

    Since we act predominantly in a software development area, I would like to share an example for the new Rule 11; an app that helps users to calculate drug doses falls into Class III, because the errors which may potentially be involved pose high-risks for the apps users/patients.

    ArrowFast FREE MDR PDF

When we look at the classification being different, does that mean that pretty much every medical device will need to go through reclassification?

Yes I agree, this will be the case, even though for most of the devices the risk class will remain the same as it was under MDD, there will be devices as well, where classification will change.

Anyhow new devices will have to go through classification. Manufacturers will have to assign an appropriate class, and this will be reviewed later by notified bodies.

Also, all old devices which have been certified already within the MDD, have already been assigned a risk class. Yet, once the certificate expires a re-certification (or new certification) in line with MDR will have to be done, and then of course the classification will have to be reviewed. And yes, if the class doesn’t match anymore, then the classification would have to be done again.

If we look at an example of MDD-compliant medical devices that are ready for renewal, will they need to be recertified under the MDR as a matter of course?

This depends on the risk class of a particular device. If the device is risk class I, no such instrument as CE certificate was foreseen under the MDR.

In all other cases however, the device will have to be recertified again. And even then, the urgency for the recertification depends on the validity of the existing certificate. The devices which were certified in accordance with MDD, remain CE-certified until the expiration of the certificate or until May 2024 – whichever comes first.

We noticed in the process of certification that many of our clients encounter significantly long waiting times with the notified bodies in Europe. Do you know why this is so, and how long do you expect this to last?

In the last five to 10 years, the number of notified bodies has been reduced. In this respect, the MDD (and MDR as well) do set requirements for the qualification of a notified body. Stricter monitoring of notified bodies indicated that some of them were not up to the requirements. Ceasing the operations of these bodies required the manufacturers to switch to the remaining notified bodies, thus increasing the queues.

In recent years, we have also experienced the trend of an increasing number of startups in the medical device industry. New technologies and fresh ideas for often new medical devices have emerged. This trend coincides with extended queues from a smaller number of notified bodies above.

Further on, the transition from MDD to MDR has been ongoing – naturally extending the conformity assessment procedures, and thus the queues. My guess is that no one expects the situation to improve significantly during the transition period, i.e. until 2024.

If medical device companies come to you and ask where do I get more information about the new medical device regulation, where do you point them?

You have several options, but certainly if one wants to be very formal and wants to be very much to the point and to detail, that would be official Journal of the European Commission, and the original text of the EU medical device regulation, which is actually quite a puzzle sometimes.

It tends to be a rather long, and isn’t an easy read. The thing is, not all the information is so direct that it can be implemented as stated, so most people need to have additional explanation and a correct interpretation of requirements at hand.

Things are clarified more in detail through MDCG guidelines. In this respect, the Medical Devices Coordination Group texts are easier to read, they are more hands-on, and more oriented towards its practical use.

However, my recommendation is not to only read the MDR or MDCG guidelines as they are, but also to visit a seminar or even consult a company which is already implementing the new requirements in practice, and that understands the requirements. It may well happen, that mutual efforts and exchange of information bring both sides to the desired results faster. So, there are many options to start exploring the regulation. Some of them require more efforts, some less.

You can also download a free MDR PDF, where you will find the important steps medical device companies need to follow in order to get a medical device certification in Europe.

Does the introduction of the MDR mean a step forward towards the alignment of the European and American medical device regulations?

In some respect, I think it does. With the question we are addressing the work and purpose of another body – after 2012 the role of previous GHTF (Global Harmonization Task Force) has been to some extent taken over by the IMDRF (International Medical Device Regulators Forum), aligning the requirements and practices on the top level.

In essence, the key objective of any regulation, as I said earlier, remains the same: each regulation sets the frame to assure safe use of devices, i.e. the related risks are acceptable, and that the devices do attain their intended purposes.

The use of standards is another topic that may be addressed, as regulations in general do consider and recognize standards, which at least to some extent unify the (technical) requirements. Perhaps it should be noted here, to consider the equivalency of standards – as national deviations may require a bit of additional work.

So, if we look at the example of the 510k being used in the FDA, but not really being available in the MDR. What’s your stand on this, how do you see the two regulations aligning in this particular example?

Well, 510k in the US is one way to go. You can basically also find the basics in the European Medical Device Regulation, for example for a similar device on the market which was reviewed and approved before, then successfully used. That might be reflected in parts of European Medical Device Regulation, like clinical evaluation, which has to be done. It foresees the possibility that there would be devices on the market which are equivalent. This is the right expression, equivalent to the device you would want to place on the market, and what one has to do is to demonstrate the equivalence between these devices. Then, based on the results from the previous device one would be able to confirm the clinical acceptance and the clinical evaluation of the new device. But, it is only one part of the European Medical Device Regulation.

We consider artificial intelligence and machine learning as the tools of choice of many new medical devices cropping up in the industry. What about the regulatory framework as prescribed in the new MDR regulation in regards to AI & ML? 

I think you are right, in recent years AI has penetrated the segment of medical devices.

At a glance, it seems the technical progress has even been faster than the regulatory progress in this field. Still, there are regular requirements for all medical software in place, with no specifics yet in the EU. Particular guidelines and proposals how to handle the field can be obtained nowadays, in other countries. Anyhow, the topic is relatively broad, so I propose we open a separate session to discuss it in detail. How would this work for you?

If you have any questions about this article or if you are interested in how you can reduce the time to market of your medical device, please contact us at The ArrowFast team of experts will be happy to help you.


ArrowFast Team

ArrowFast Team

ArrowFast Team - A group of Medical Device Engineering Specialists

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