Program

09:00

Plenary session 1

ENG

MDR/IVDR transition and innovation

The MDR/IVDR requires the full recertification of all medical devices according to the new requirements. This transition involves enormous costs, leading companies to withdraw a significant portion of their devices from the market, or smaller manufacturers to simply cease production.

Additionally, during the transition period, no significant modifications to the devices are possible. According to manufacturers, the current European regulations stifle innovation. The first regulatory approvals for innovative medical devices have shifted from Europe to the United States. How, then, can European medical innovation be sustained within the current regulatory framework, or how should the regulations be changed to reinvigorate innovation?

Dr. Joó Tamás

Journalist

Diana Hoch

CEO & founder

Thomas Childers

Manager

11:15

Plenary session 2

HUN

MDR/IVDR transition experiences

In the past period, especially after the MDR's mandatory application deadline of 05/26/2024, more and more CE certificates have been issued, so all involved actors have more and more experience. How do notified organizations see the submitted technical documentation? What kind of experiences can the consultants pass on?

Dr. Joó Tamás

Journalist

Diana Hoch

CEO & founder

14:15

Plenary session 3

HUN

New horizontal requirements

The medical technology industry's burdens related to the MDR/IVDR transition will be further increased by the EU's new horizontal legislation to be introduced in the near future. What new horizontal requirements appear? How can these requirements be met?

Dr. Joó Tamás

Journalist

Diana Hoch

CEO & founder

15:15

Plenary session 4

HUN

The practical applications of AI

So far, we have only talked about the huge potential of Artificial Intelligence (AI), but free generative AI applications have democratized the technology, making it accessible to anyone. It has become clear that anyone who does not use AI, including even to make their daily work more efficient, will be at a competitive disadvantage in the market. But what, how can you use AI? What results can we expect from the application of AI?

Dr. Joó Tamás

Journalist

Diana Hoch

CEO & founder

19:00

Dinner

Gala Dinner Reception

Room 1

Room 2

Room 3

Room: Amazonas 1

09:30

Section 1

ENG

New horizontal requirements

The topic brought up in the panel discussion of the plenary session is explained in more detail in this section. The speakers present the effects of the AI regulation, the cyber security regulation (NIS2), the GDPR, and the green transition / new battery regulation on the health industry.

Dr. Joó Tamás

Journalist

Diana Hoch

CEO & founder

Thomas Childers

Manager

10:45

Section 2

ENG

eHealth

One of the political priorities of the EU is the digital transition, of which eHealth is a part. eHealth, i.e. innovative digital healthcare and care, can improve the quality and availability of care, as well as increase the overall efficiency of the healthcare industry. In the section, we will explore the possibilities provided by the European Health Data Space or cross-border electronic health services.

Dr. Joó Tamás

Journalist

Diana Hoch

CEO & founder

Thomas Childers

Manager

13:30

Section 3

ENG

Software development challanges

In contrast to devices, it is almost impossible to determine the adequacy of medical software with subsequent tests, which is why strict supervision and documentation of the design process is essential. This presents great challenges for developers. In this section, we provide support to address these challenges.

Dr. Joó Tamás

Journalist

Diana Hoch

CEO & founder

Thomas Childers

Manager

14:45

Section 4

ENG

eRegulatory

Fulfilling the increasingly strict regulatory requirements in the near future is unthinkable without digitization. Countless digital solutions are available on the market, from planning to the creation of technical documentation, the development of which was boosted by the application of AI for even more efficient solutions. In this section, we are looking for an answer to the question, what is the future of handling regulatory affairs in the age of AI?

Dr. Joó Tamás

Journalist

Diana Hoch

CEO & founder

Thomas Childers

Manager

Room: Amazonas 2 + 3

09:30

Section 5

ENG

FDA workshop

The alarming requirements of the MDR/IVDR have directed the attention of innovative manufacturers to the United States, a market in which it currently seems easier to bring an innovative product to market than in Europe. In this section, we present the success factors of FDA approval, potential pitfalls, and what awaits the manufacturer after certification in the world's largest medtech market.

Dr. Joó Tamás

Journalist

Diana Hoch

CEO & founder

Thomas Childers

Manager

10:45

Section 6

ENG

MDR transition best practice

We will continue the session presenting good practices, which aroused great interest at last year's conference. We present the first Hungarian company with a CE certificate, the questions of the daily operation of the PMS system, and the effective practical application of UDI.

Dr. Joó Tamás

Journalist

Diana Hoch

CEO & founder

Thomas Childers

Manager

13:30

Section 7

ENG

Additiv (3D) Manufacturing Technology

Although the topic of additive manufacturing (3D printing) is not new, this technology is now starting to break into industries with high technological expectations, such as the medical technology industry, the automotive industry, the aerospace industry or the space industry. In this section, we present the related new standards and technical solutions.

Dr. Joó Tamás

Journalist

Diana Hoch

CEO & founder

Thomas Childers

Manager

14:45

Section 8

ENG

Challenges from design to production

From a working prototype to a manufacturable product is a long journey. The design and development must be completed, and the medical device needs to be produced at the appropriate quality. This lengthy process is fraught with numerous pitfalls, and in this section, we offer useful tips to help navigate them.

Dr. Joó Tamás

Journalist

Diana Hoch

CEO & founder

Thomas Childers

Manager

Room: Amazonas 4 + 5

09:30

Section 9

ENG

Development opportunities of the Hungarian healthcare innovation ecosystem

The development of the Hungarian health industry innovation ecosystem is supported by all interested parties, but different points of view can already be identified in terms of solutions. In this workshop, representatives of state actors, large domestic companies and investors will look for possible solutions that take into account the perspectives of all interested parties.

Dr. Joó Tamás

Journalist

Diana Hoch

CEO & founder

Thomas Childers

Manager

10:45

Section 10

ENG

Opportunities and Challenges in Establishing University Spinoffs and Startups: How to Embrace Market Logic in University Innovation Ecosystems?

Since both life sciences innovation and academic systems are inherently international, this session will feature speakers representing a variety of ecosystem roles and geographies. The discussion will focus on the opportunities and challenges in establishing university startups and spinoff companies.

Dr. Joó Tamás

Journalist

Diana Hoch

CEO & founder

Thomas Childers

Manager

13:30

Section 11

ENG

Mini Scientific Student Conference

The organizers of the conference consider it extremely important to address innovative university students as well, to involve them in the professional blood circulation, and at the same time provide them with an opportunity to build their relationships. We implement this mission with the involvement of the BME Medical Technology Voluntary Circle in the framework of a mini Scientific Student Conference. The presentations are selected in the framework of a tender, which can be submitted with theses prepared in 2023-2024.

Dr. Joó Tamás

Journalist

Diana Hoch

CEO & founder

Thomas Childers

Manager

14:45

Section 12

ENG

Drug-Device Combination Products

Special requirements apply to combined drug-device products in the MDR. It is a big challenge for manufacturers that in addition to the notified body, the drug licensing authorities must also be involved in the conformity assessment. In this section, we will review the difficulties and try to offer solutions.

Dr. Joó Tamás

Journalist

Diana Hoch

CEO & founder

Thomas Childers

Manager