The forum for the regulatory requirements of the MDR and IVDR enters the next round. This year, it will once again take place as a face-to-face event at the Landesmuseum Mainz. Alternatively, it is possible to join in via livestream. Our CEO Miriam Schulze will be there with two presentations:

Through the regulatory jungle: successful software development under the EU Medical Device Regulation
The presentation aims to guide the audience through the jungle of Regulation (EU) 2017/745 and sensitize them to the key aspects and requirements in the development of software. It will address the importance of each challenge and explain how these can be successfully overcome. The following key questions are used to navigate the audience through the jungle:

• Classification: Is it medical software, yes, no or maybe?
  And if so, which class?
• Technical documentation: What and how must be documented?
• Cybersecurity: What measures are required to protect the software from cyber threats?
• Risk management: How can risks be identified, assessed and controlled?
• User-friendliness (usability): How is it ensured that the software can be used safely and effectively?
• Clinical evaluation: How is the performance and safety of the software proven?
• Post-Market Surveillance (PMS): How is the software monitored and further developed after the market launch?

Between the AI Act and MDR: regulatory framework for AI-supported medical devices
The panel discussion will shed light on the complex regulatory requirements arising from the introduction of artificial intelligence (AI) in medical technology.
With the parallel implementation of the EU’s new AI Act and the Medical Device Regulation (MDR), Europe faces the challenge of creating a coherent and innovation-friendly environment. Experts from the medical technology industry, legislation and the healthcare sector will discuss how these regulations can be reconciled in order to ensure both the safety and effectiveness of products and to promote innovation in the industry. The focus will be on identifying synergies and conflicts between the regulatory frameworks, practical experiences and future prospects for the development and market launch of AI-supported medical devices. The discussion aims to derive concrete recommendations on how regulatory processes can be optimized in order to strengthen Europe as a leading location for medical technology innovations.

Sounds exciting? Our experts look forward to meeting you at the eHealth Congress.

You are welcome to connect in advance: