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Anne Matousek
Senior Consultant QM & RA, Regulatory Affairs Expert

Tel.: 07131 2774-40
regulatoryaffairs(at)seleon.de

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07.07.2021

BACKWARDS NEVER! FORWARD ALWAYS!

The manufacture of medical devices must comply with the latest scientific data and regulations, including the MDR. Clinical trials and evaluations form the basis for this. And on the far side, constantly adapted input brings about innovations, which in turn benefit the users.

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Benefit for patients/innovation as a duty

If one looks at the MDR for the first time (or twice, or even several times), one can initially get the impression that the MDR is a pure paper monster, even a job creation measure - at least for medical device manufacturers, but also for authorities and notified bodies. However, on closer inspection, one can also come to the conclusion that there is a lot of potential for innovation here after appropriate preparation of one's own processes. This can be seen from some of the introductory recitals. At this point, you can briefly inform yourself about the most central topics that offer you the opportunity for innovation:

Problem

... we have a problem...

To be observed especially in processes of change and thus also in the current situation.

 

Problems suddenly appear on all sides and we focus on the problem that seems to be the biggest.

In doing so, we often react because we are no longer able, no longer have the time to act actively, we can only react.

However, this does not lead to that,

that we would actively tackle the other problems.

Here, too, people tend to wait and hope,

that the problem will somehow "shrink", disappear and thus take care of itself.

 

Most problems, however, do not do us this favour.

They just stay ????

 

In addition, there is our own thought structure.

We mostly look for interlocutors who confirm our perception of the problem and

together and in conversation, the problem grows almost "immeasurable".

In the end, hardly anyone has an idea,

where we should best start,

because one thing is quite clear,

under no circumstances must we make mistakes in the process.

 

While we plan the problem concretely and keep talking about what can happen, our actions also change more and more in our heads. We are afraid.

 

Do you know the phenomenon?

This description of the problem comes from Claudia von Schönburg, who, among other things, moderates and accompanies conflict situations as a mediator, and got us thinking. We too are familiar with this phenomenon. It appeared to us in the context of the MDR.


The MDR aims to promote the regulation of medical devices over their entire life cycle, so that the most diverse phases are covered.
The fears of many manufacturers of medical devices that the MDR could prevent innovation in the EU (e.g. through hurdles for start-ups, increasing costs due to the required clinical studies) are countered by the basic idea of constantly reviewing and thus improving products.
Certainly, the MDR imposes new and extended requirements, including the documentation of the clinical efficacy of products (clinical trials). The innovation in the product should be described in the clinical evaluation and, if necessary, in the context of a clinical trial.

The Medical Device Regulation EU 2017/745, adopted in 2017, aims to be modern, to take up innovations and now also reflects the current development in the field of eHealth - it contains points that better regulate medical devices that contain software. For example, companies need to test and understand the capabilities and limitations of the platforms they work on. This includes variables such as contrast and size of screens. Minimum hardware and IT security requirements, including protection against unauthorised access, are now set by the manufacturer. The implementation of these requirements can help improve public opinion on transparency and patient safety in the medical device industry.

In principle, MDR promotes deeper insight into the product, its application in reality and thus a better understanding. Be honest, how many products have you discovered in the course of remediation that you do not know the true intended purpose? Perhaps you have also discovered products that are not medical devices by definition? Did you also have an epiphany regarding indications when you reviewed the literature for clinical evaluation according to MEDDEV 2.7/1 Rev. 4? These are only two examples that show how we can also generate more knowledge through the additional effort.

And even after obtaining the CE mark, the MDR provides a number of specifications/tools that are often viewed negatively by manufacturers because they are associated with time and financial expenditure. Yet they offer opportunities to improve products. These are mainly increasing requirements for:

  • clinical evaluation,
  • Post-market obligations,
  • Risk management,
  • essential safety and performance requirements.

At first glance, this may seem like a pure burden for the manufacturer, but in fact this is exactly what provides the space for innovation and improved patient care. But let's take a look at this in detail.

 

Clinical evaluation and the collection of own data

The MDR, including the associated guidance documents, obliges manufacturers to conduct a clinical evaluation of their medical devices, regardless of their risk class. This involves systematically collecting, collating, analysing and evaluating clinical data on a product in order to verify the safety and performance as well as the clinical benefit of the product. For some risk classes and product groups, clinical trials will become almost inevitable in the future. Post-marketing clinical follow-up, the PMCF/Post Market Clinical Follow-up, is also envisaged.

The aim is to present detailed evidence of the performance and safety of the product as an overall picture of the current state of knowledge. To this end, it is necessary to review the assessment at regular intervals to ensure that it is up to date.

The clinical evaluation via literature (equivalence principle) is only possible for proven similar products, the waiving of clinical data is only possible for non-critical products and with justification by the manufacturer.

These innovations will certainly lead to a higher effort and cost for manufacturers with regard to clinical evaluation in the future.

But: Since the collection of clinical data is generally necessary, the effort of a clinical trial for novel products is put into perspective, since it might already be necessary for the existing product.
Also, innovative products will no longer be "disadvantaged", since expenses for clinical data will now arise for most products. In principle, it is questionable whether it is worthwhile to "wait" for a competitor to place an innovative product on the market using its own studies for "piggybacking on" it with a favourable equivalence assessment.

It would be better here to get to know one's own product better and to invest some time and money in performance data (aka preclinical data).
For the external perception of the products by users and patients, this means higher confidence in the general conformity assessment procedures. Finally, each manufacturer demonstrates through performance and clinical data that their product is safe and performs well, the risks of use must be proportionate to the expected benefits.

These requirements for safety and performance already existed under the MDD, but the requirements for evidence have been specified in the MDR.

The assessment of whether it is an equivalence product is much more profound, as the transferability of the existing clinical data needs to be justified in a much more informed way and supported by further data.

The IVDR also describes performance evaluation as an ongoing process to demonstrate the clinical performance of devices. For this purpose, the current standards should be searched to determine the state of the art and to identify specifications for testing.

 

Post-market obligations: Obligation for post-market surveillance by the manufacturer.

The EU MDR/IVDR regulations significantly strengthen post-market surveillance of devices. Manufacturers must plan, establish, document, apply, maintain and continuously update a post-market surveillance system that complies with Section I/Chapter VII of the MDR (in the IVDR also Chapter VII, Article 78 ff and Annex XIII). This system is part of the manufacturer's QM system (according to Article 10(9)) and must be designed appropriately for the risk class and type of device.
This requirement covers the entire life cycle of the medical devices, collecting and analysing data on performance, quality and safety. This allows for continuous improvement, preventive measures and corrective actions.
The data collected can be incorporated in many sections:

  • Continuous improvement and updating of risk management (in accordance with Annex I, Chapter I), (risk-benefit assessment)
  • Update of the clinical evaluation
  • Improving the performance, safety and usability of the product and thus updating/improving the instructions for use and labelling, if necessary.
  • Update of the summary report on safety and clinical performance (Art. 32)
  • To identify trends (Art. 88)
  • To identify and initiate the need for preventive, safety and corrective measures "in the field" (notification according to Art. 87 if necessary).
  • The corresponding update of the technical documentation

Such a monitoring system is suitable for systematically collecting and analysing relevant data on the performance and safety of the product over the entire product life cycle, so that manufacturers can and must draw necessary conclusions (keyword trending), get to know their product better and, if necessary, implement and monitor preventive or corrective measures. Here, too, the striving for a continuous improvement of products and their safety can be seen, from which not only consumers/patients/users, but ultimately also the manufacturers benefit and approaches for innovations are offered.

 

Updating/continuous improvement of risk management

As a central component in the realisation of medical devices, risk management is of particular importance. A positive risk-benefit assessment is indispensable for a positive conformity assessment procedure, and the MDR clearly specifies the processes of risk management. Particularly with regard to documentation, it thus imposes significantly increased requirements. Annex I, section 3 states: "Risk management is to be understood as a continuous iterative process throughout the life cycle of a product, which requires regular systematic updating." For risk analyses that may have been superficial up to now, this now means that they must be adapted to the level of detail required in the future. This also offers opportunities: already at the beginning of product development, risk management can help to identify and reduce the potential risks of the product parallel to the development processes. For the post-market section, the PMS (Post Market Surveillance or "manufacturer's system for post-market surveillance") already mentioned above is required, which is regularly reconciled with risk management. Thus, a statically structured risk management file now becomes a dynamic risk management system that must be lived. This leads to a regular update of the risk-benefit assessment and thus to an improvement of the risk management. Certainly, the additional documentation required to meet the increased requirements of the MDR depends individually on how the existing system looks and has been maintained, and may pose a major challenge to the individual manufacturer. But once this work has been done, the added value already described can be derived for the manufacturer (especially the responsible person is very happy about a properly maintained risk management with a lot of input from different directions), but especially for the patient. And depending on the target markets, this could mean a benefit not only for European patients, but also for target countries outside Europe (not yet considered by the manufacturer) and their patients.

 

Always up-to-date evidence of the safety and efficacy of medical devices:

The Essential Requirements have become Essential Safety and Performance Requirements (GSPR). Compared to the Essential Requirements of the MDD, the scope and level of detail of the requirements has increased significantly. Strictly speaking, the MDD already lived by the principle of continuous conformity assessment, but this was often not understood as a continuous process, but as a final element of a product development. Due to the increased documentation obligations in the area of the Essential Safety and Performance Requirements, the manufacturer is constantly confronted with the question, for the benefit of the user and patient, of whether his product actually corresponds to the current state of the art on the revision date and can be placed on the market by him with a clear conscience. And this really means the day. This is not a pillory with retroactive apportionment of blame, but a constantly weighing decision as to what one's own product can do, taking into account the currently available knowledge and data.

 

Our conclusion:

The obligations of manufacturers go far beyond placing on the market, but at the same time the tools of the MDR give the opportunity to continuously improve products and review their safety and performance. Regular feedback from doctors, users, patients as well as data from PMS activities can lead to more innovative products, more satisfied users and thus to continuous improvement. Global harmonisation of medical device regulations is also being pursued and has found its way into part of the MDR processes, so that distribution beyond EU borders could be simplified. And the users and patients are being demanded within the MDR to participate more in the process of improving the products at European and national level, too.

In the end, everyone benefits from the new MDR tools: the manufacturers, the users and the patients, which could eventually become anyone. They benefit from continuous improvement of medical devices and monitoring of their safety and performance. Development planning is moving further into the foreground, with user needs in particular playing a central role. Innovations should not be prevented by the new MDR, but rather encouraged. On the other hand, it should not be ignored that start-ups in particular could find the hurdles for the approval of a medical device, which have been set high by the MDR, to be a deterrent and at least put their plans for an innovative new medical device on hold.

The many new implementations also offer companies the opportunity to put processes to the test and discover optimisation possibilities. The new requirements and guidance from the standards and the GSLA of the MDR, if carefully applied, help in the continuous improvement of existing products, e.g. in the context of a risk management review. Conscientious PMS activities can quickly identify when new risks emerge or the state of the art is no longer achieved or ultimately the risk-benefit ratio shifts. All this should always be kept in mind with regard to the necessary, fundamental trust of patients in medical technology, especially in Germany as an internationally recognised location for medical technology.

To conclude, in the words of Ms. von Schönburg;

You probably all know this ;)

 

You listen to people when they announce an innovation,

what we're up to,

how we are going to do everything,

today also very important why we want this.

 

It sounds, well, let's say great.

You and most, it seems at first, may be looking forward to it.

Now this heralded innovation is meeting real-life practice,

on their people,

on the procedures and processes that are lived

(these are often written somewhat differently in the QM report)

On people's attitudes towards change

own power structures,

own framework conditions,

one's own ego.

 

Innovation meets reality

 

What happens now,

you probably know

all of them too.

 

The doubters have their say.

Oh, we can't do it that way.

That is a problem.

We have never done it like this before.

That's not where we get the others.

You can't because.

We have to think about that again.

 

I like to hear about your implemented innovation projects that still resemble the announcement at the end of the process.

 

I am curious.


You are ready for innovation but want external support? seleon has many contacts to various funding opportunities and can actively support its customers in applying for them. You are not yet ready for innovation because you are still working on the implementation of the MDR? In this case, too, we are happy to support you in designing your processes and maintaining your documentation so that you soon have room for innovation again.

 

Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only.

Every product is unique – the mandatory tasks and measures for entering the market need to be specified individually. seleon advises you on your individual questions without any obligation.

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