(Frankfurt a. M./Nuremberg, 17.05.2023) The European Medical Device Regulation (MDR) has been in effect for manufacturers for about two years now. The challenges are immense. Therefore, the EU Commission has again significantly extended the transition periods. This means that certificates that have already been issued are valid for longer. However, to a large extent, the problem is only being pushed back. The fact is that regulatory requirements in Europe have risen sharply. MDR will therefore also be an important topic at MedtecLIVE with T4M 2023. At the European trade fair for medical technology, product developers and buyers from distributors, OEMs and suppliers will exchange views on the current challenges in the industry from May 23-25 in Nuremberg.
Regulation prevents innovations
At MedtecLIVE with T4M, VDE will be addressing the approval of software as a medical device. Artificial intelligence, for example, has the potential to revolutionize the medical field as well. With the unsatisfactory legal situation in Europe, companies could be left behind compared to their competitors from the USA, for example, says Dr. Cord Schlötelburg, Head of VDE Health: "With the MDR, Europe has created a regulation that hinders innovation. We want to show smaller and medium-sized companies in particular how they can still remain competitive in medical technology."
Entire processes and documentation must be MDR-compliant
For both existing and new products, the entire processes and documentation must be revised or newly created and thus made compliant with the Medical Devices Ordinance. This requires corresponding investments in know-how, infrastructure and employees and is a challenge especially for small and medium-sized companies, such as start-ups or innovative high-tech SMEs. During MedtecLIVE, VDE will therefore discuss with its experts how medical software can reach the market safely, quickly and compliantly.
Regulation of medical software at MedtecLIVE with T4M
Dr. Cord Schlötelburg and Dr. Thorsten Prinz, Senior Manager VDE, will discuss the impact of MDR on the approval of medical software together with industry lawyer Dr. Zeynep Schreitmüller from the product law firm and Peter Hartung from the consulting company seleon GmbH. Among other topics, they will discuss the certification of AI products and what start-ups should consider.
Event details: Messezentrum, Messepiazza 1, Nürnberg Messe, May 23, 2023, 13:00 – 14:15