🇨🇿 Digital Omnibus: Amendments to the AI Act and Regulatory Sandboxes

The event is held in Czech language only!

Artificial intelligence is playing an increasingly important role in the development, manufacture, conformity assessment, distribution and use of medical devices. It is also an integral part of certain software devices. The AI Act will therefore have a significant impact not only on standalone AI systems, but also on medical devices and in vitro diagnostic medical devices that incorporate software or other technology using artificial intelligence.

The Digital Omnibus introduces changes to the timetable for the application of the AI Act, modifies certain obligations of economic operators and redefines the powers of European and national authorities. Of particular importance to the medical device sector are the relationship between the AI Act and the MDR and IVDR, the interaction between the applicable regulatory requirements, and the manner in which obligations under the AI Act will be incorporated into existing processes for risk management, technical documentation, clinical evaluation and conformity assessment.

A separate part of the webinar will be devoted to regulatory sandboxes. These may enable medical device manufacturers, software developers, healthcare providers and other entities to consult on, develop and test innovative AI solutions under the supervision of the competent authorities, including testing under real-world conditions.

Who is the webinar for:

• manufacturers of medical devices and IVDs

• developers of medical device software and AI systems

• healthcare providers

• notified bodies and regulatory professionals

• legal, compliance, IT and cybersecurity teams

• management teams of companies implementing AI solutions in healthcare

Speakers:

• JUDr. Jakub Král, Ph.D.

• Ing. Jan Kavalírek (CEE Ambassador for Artificial Intelligence and New Technologies)

Content:

• key changes introduced by the Digital Omnibus

• revised AI Act timetable

• high-risk AI systems

• AI as a component of a medical device

• relationship between the AI Act and the MDR and IVDR

• obligations of manufacturers and other entities

• technical documentation and risk management

• conformity assessment of AI-enabled medical devices

• role of notified bodies

• purpose of regulatory sandboxes

• conditions for admission to a sandbox

• protection of personal and health data

Further information:

• participants will have the opportunity to ask questions during the webinar

• each participant will receive a certificate of participation

• a PDF presentation will be sent to all participants

Participation fee:

• 3.900 CZK excluding VAT 

• 100 % cancellation fee applies after bindingly confirmed registration, but with the possibility of sending a replacement participant

Webinar organized by:

• Porta Medica Legal s.r.o., advokátní kancelář

  IČ: 17491681, DIČ: CZ17491681

  Registered office at Opletalova 1525/39, 110 00, Prague 1 - Nové Město