MDR, IVDR regulations and benefit of obtaining EU regulatory approvals

8/21/2024　

On September 6, 2024, the 11th “U.S. Medical Device Market Entry Seminar”, hosted by Globizz Corporation and sponsored by the U.S. Embassy in Japan, will be held. We will invite F. Tóth András from QTICS Group, a European medical device consulting company, as a guest speaker. He will provide insights of the European market and EU regulations that will also be useful information when expanding into the U.S. market. Prior to the seminar, we conducted a preliminary interview with Mr. András and he explained about QTICS Group's services, the current state of MDR and IVDR regulations, and the appeal of the European market.

At the seminar on September 6th, Mr. Andras will give a more detailed presentation, and there will be an opportunity to speak with him directly during the networking event following the seminar. Additionally, on September 9th, individual meetings will be held with companies considering entry into the EU market. Please check the bottom of this page for more details.

Can you introduce QTICS Group services for medical device companies?

Qtics：QTICS Group is a three-year-old service group, which has four main Divisions: Automotive, Energy - Industry, IOT-Consumer, and Medical. All our divisions have wide range of accreditations and capabilities through the participating member companies. In the medical division, several companies joined together to create an intelligent service package for medical device manufacturers that want to get CE certifications, that allows them to sell medical device products inside the European Union. Our service supports all kind of medical device manufacturers from all over the world that want to be active and successful in the European market. Those companies need to meet the requirements by the European regulations and the European or international standards. Our service group, which has eight member companies that can cover the full conformity lifecycle from regulatory, quality issues to preclinical tests and clinical validation that all needed for the successful certification of the device.

Who are your clients? Domestic or international, small or large?

Qtics：In the first two years of QTICS medical, we have been mainly working with Hungarian medical device manufacturers, mainly small and medium size. But in the last year, we have more and more requests and clients from international companies. We have German, Korean, Japanese and Chinese clients and projects as well. As I said, the regulation and the requirements for manufacturers are the same in the European Union. We can serve all size and type of international companies hopefully more and more from the Japanese market too. We can cover all type of MDR and IVDR devices and happy to receive inquiries from startups, traditional midsize or from large companies, whomever who want to sell a product in the European market.

Situations surrounding MDR, IVDR update - is everyone catching up?

Qtics: This is a huge subject, which would need an entire interview. The European Union created probably the toughest legislation seven years ago, so this is not new for the manufacturers. Still, because it's a very complex regulatory framework, many manufacturers are not up to date. This is a big part of our work that we help and guide the manufacturers in the ‘sea of requirements’ and I must tell that in that sense there's no big difference in the European or other worldwide industries. These requirements are tough, takes a lot of time and need proper financial resources as well. The ambition of the European Union legislators was to create a regulatory framework by which users have only enable safe and well performing devices. This is an ongoing and I would say endless discussion in Europe that the regulation become too tough, but now it's a fact that manufacturers must accept and work accordingly. If someone wants to sell a product, it must meet these requirements, there is no other way around. This is true for the legacy devices, so those ones that had certification under the Medical Device Directive and certainly true for those ones, that are new and were not on the market before or were not sold in the European market beforehand.

I think many Japanese companies are hesitant to challenge for EU market because they think MDR became much harder to comply with after the update. Do you have any comment or advice for them?

Qtics: I think the most important thing is that the European market is still one of the largest. It's a very important reference point Worldwide. If someone is entering the European market, will have access potentially to 400 million consumers, which is another important fact. And yes, the requirements are tougher, but no one should forget that in many other regions of the World the CE certification is a gateway pass to the market. So if someone gets the MDR CE certification, will have access to a lot of potential clients. The good news is that QTICS Medical can help to the manufacturers to get through the labyrinth of requirements. It's our task. To perform all task takes time and of course costs money, but it is doable. We are here to help, and this is something that I will highlight in the presentation on the 6th of September, that there is help, there are clear guidelines, there are clear expectations and even smaller companies, but especially the mid-size or the large companies can get through this pathway. We can guarantee that the result will be good for certification and the Notified Bodies will receive well and will issue the certifications based on the technical file that QTICS Medical supported. Well prepared technical file is the key, that can make the certification process and the time to market faster.

Do you think there is an advantage on having FDA approval when entering EU market?

According to our experiences, there is a clear advantage of having an FDA approval for medical device manufacturer when considering or entering the EU market. Just to mention a few points, the quality management system requirements are very similar or will be almost the same soon. It means that a manufacturer that is already in the US market won’t have to create a new quality management system when entering the EU market. The international standards for the preclinical and clinical tests and validations are equivalent, which means that in most cases, the manufacturers do not have to repeat these tests under the European conformity procedure. A third point that is important that the market access is different. A manufacturer that is already in the US market and willing to enter the European market will probably find it easier to enter our huge market, while the conformity procedure, as explained, is not so easy, but what comes after will be probably easier, lighter, and faster, which is a very important information for the manufacturers. An important additional point is that there are a lot of similarities in terms of how to prepare the technical file. The International Medical Device Regulatory Forum (imdrf.org) is working on that and the manufacturers can review this website and see the similar or different requirements of a well created technical file that must be submitted in most classes to a selected Notified Body under the European requirements. QTICS Medical can also help with the selection if the right Notified Body.

What else are you going to speak about during the seminar?

Qutics: It is a huge opportunity for QTICS Medical to introduce its complex intelligent service structure for the Japanese manufacturers. I hope that this personal meeting and the presentation will convince Japanese medical manufacturers to enter the European market, which is very advanced, competitive but can provide many new business opportunities.

I hope that in these personal meetings and during my presentation, I will be able to convince the participating manufacturers that are new to the EU market to start this journey. I will be there to answer all questions, to talk about the possible dilemmas or professional inquiries. I do hope that many companies will use the opportunity to meet with me personally as I'm making this trip with the ambition to present the promising possibilities, our service portfolio and to initiate as many medical device conformity project discussions as possible.