The new EU regulation on medical devices – known as the MDR (Medical Device Regulation) – became legally binding on 26 May 2021. What does it mean for medical device manufacturers operating in the European market? Stephan Vogel, Head of Business Development and Florian Pichl, Head of Business Development Plastics at Kistler, discussed this question with Urs Müller, an expert at Johner Institut Schweiz GmbH. This is the Swiss branch of the Germany-based Johner Institute, and it advises companies on the issues involved in legally compliant development, quality management and approval of medical devices.
What does the new MDR mean for manufacturers of medical devices? An interview with an expert
"There are always winners and losers. Companies that switched or extended their business models to digitalization at an early stage are winners."
Urs Müller, Expert at Johner Institut Schweiz GmbH
Mr. Müller, thanks so much for taking time out to talk with us about the latest developments – of course, MDR is on everyone’s lips these days. What objectives does it aim to achieve? What specific, practical changes does it involve? And what does the MDR mean for the industry?
U. Müller: First of all, thanks very much for inviting me to be interviewed! One important reason for introducing a new European legal basis for the regulation of medical devices was to achieve stronger control over manufacturers and authorities. It entails new – and higher – requirements for development, production, sales and marketing, and also for post-market surveillance. These changes will have a particular impact on the collection of data regarding product use. You can already see this from the fact that the MDR is actually a law, unlike its predecessor – the MDD (Medical Device Directive) – which was a guideline. For instance, there are higher requirements regarding the scope of technical documentation, safety and product performance, and also proof of clinical benefit. In addition, there are extended reporting obligations: these include the publication of information about performance and safety in EUDAMED, the new pan-European database.
What are the challenges that manufacturers have to confront at present – as regards existing products as well as new approvals?
U. Müller: Manufacturers whose portfolios include very large numbers of products that are compliant with the old legislation now have to revise their entire documentation so that it conforms to the MDR; they must also provide (additional) evidence – including clinical proof in some cases – that their products are effective and that they deliver the promised benefits. This is leading many manufacturers – especially small niche manufacturers – to withdraw products from the market. The products then become unavailable, so patient care suffers.
Another challenge concerns approvals for medical devices: the new requirements for Notified Bodies are substantially higher. There will be fewer Notified Bodies going forward – Switzerland does not actually have a Notified Body at present – and not all of them will be allowed to test the full range of products covered by the MDR. This will lead to long queues and in some cases, manufacturers who are forced to change because their Notified Body has ceased to exist will need over a year to obtain new approvals. There will be huge delays in the repayment of investments because of this.
Yet another challenge is the de-facto abolition of OEM-PLM structures, as they are known [value chains consisting of an Original Equipment Manufacturer and a Private Label Manufacturer – editorial comment]: in other words, licensed production by third parties. If PLMs must now hold complete technical documentation on the devices they sell, that means they get the OEM’s entire know-how about the production of the device – and this goes against the idea behind the OEM-PLM relationship.
You’ve just mentioned the area where you’re actively involved at the Johner Institute. Which parts of the content do you focus on in your consulting work?
U. Müller: It's several years since we began conducting training courses on the MDR, which was actually published back in 2017. Various concepts and requirements were not fully developed at the outset: the EU only specified the practical details at a late stage, in 2019 or 2020. As soon as new information became available on these topics, we immediately set about processing the content for medtech manufacturers and our clients – in our blog articles, for instance, or with more in-depth treatment as a video series in our “Audit Guarantee” training program. One example of the subjects covered is UDI [Unique Device Identification regulations – editorial comment]. In my work, I see that companies which develop software are under a particular obligation to set up a clearly structured development process, and they have to provide more comprehensive and precise documentation for the software, including the risk analysis. I’ve already mentioned the clinical evaluation. We help manufacturers to provide evidence of clinical benefit on a more qualitative basis; also, we’ve partially automated the analysis of market data and the processes of searching the literature and writing the text so that high-quality reports can be produced within a short period. We’ve developed tools that help manufacturers to respond more rapidly to changes in standards and laws.
In some cases, on top of all this, manufacturers from non-EU countries such as Switzerland have to create new roles such as distributors or European authorized representatives (known as “economic operators”) before they can even maintain their market access to the EU. The Johner Institute performs the role of authorized representative on the manufacturer’s behalf so that EU manufacturers can continue to market products in Switzerland and, conversely, so that Swiss manufacturers can market products in the EU.
Manufacturers are obviously faced with plenty of challenges now that they have to implement the MDR. But does it also offer opportunities for new business models and technologies, for example?
U. Müller: There are always winners and losers. Companies that switched or extended their business models to digitalization at an early stage are winners. As I see it, the drivers are more technological in nature – artificial intelligence, for instance; in view of social trends such as the aging society, they have huge potential for penetrating the market. New business models for the provision of services and products are also emerging in connection with the digitalization of the world of business and work. This already shows that the digitalization of business processes will play a very important part in the future – for example, to automate the documentation, surveillance and report generation processes. Manufacturers, authorities and providers will have to create suitable interfaces and data formats for information exchange throughout the entire value chain, as far as the patients themselves. Ways of developing better products from information and data will change in the future, and this will give rise to new business models. The MDR is not the main driver, but the MDR has definitely accelerated these requirements.
How is the MDR impacting supplier management and supply chain transparency?
U. Müller: These requirements are very straightforward: there is merely an obligation to document all suppliers involved in production and development, and all processes set up for production. The MDR does not go into more specific details. In this area, the revised ISO13485:2016 standard provides more clarity: it defines the requirements to be met by a quality management system for medical devices, and it also includes supply chain management. As regards compliance with the requirements for supplier management, our experience of implementation shows that more audits are being conducted – especially for critical suppliers, and even despite the presence of a QM system – so for that reason, all QM processes must be documented very accurately.
In relation to the new MDR, how do you assess the use of inline process monitoring of the type supplied by Kistler, for example?
U. Müller: The MDR contains only a few specific requirements for the manufacturing process as such. But if we look at the broader picture in relation to the requirements in the MDR, the advantages of continuous process monitoring are obvious: as well as simple, additional possibilities for assessing product quality, automated monitoring directly provides comprehensive records as evidence of production data. Increased (and preferably automated) availability of specific data will make it possible to map various aspects of the entire quality management process more efficiently. Bearing this in mind, I anticipate that the increased requirements – especially as regards process transparency and documentation – will prompt more and more manufacturers to opt for these solutions going forward, so they can store, process and evaluate their production data from various sources.
Mr. Müller, many thanks for your assessment, and for this detailed discussion! Just one more question to finish: which trends and developments do you see for the medtech industry as a whole?
U. Müller: As well as the aging society, which is generating heavier demand for medical devices in general, other trends include personalized medicine, assisted living homes, and evidence-based medicine. Artificial intelligence (AI) will be one of the fundamental technologies for these developments. In the next ten to twenty years, this technology has the potential to revolutionize our society – and the medtech market as well. Another important area where progress is urgently needed is regulatory science – the creation of better regulations on a technical and scientific basis.
The key success factors here are the requirements we specify, and our approach to the issues of IT security and data protection. Data protection and IT security directly influence the extent to which the various systems involved in treatment can be successfully networked, all the way through to the patients themselves. To achieve this, we need digital interfaces and standardized data formats – either for communication between products and/or systems, or also for transmitting the information required for regulatory purposes to oversight bodies and authorities. The overall aim here is to make processes more efficient so that technical advances can ultimately be made available to the patients.