The "The EU Regulations for Digital Medical Devices with AI Components - A Basket Full of Requirements - What Does a Manufacturer Need to Consider? (Dec 9, 2025)" training has been added to ResearchAn...
Autore: Business Wire
DUBLIN: The "The EU Regulations for Digital Medical Devices with AI Components - A Basket Full of Requirements - What Does a Manufacturer Need to Consider? (Dec 9, 2025)" training has been added to ResearchAndMarkets.com's offering.
This compact 4-hour specialist course provides manufacturers, developers and quality managers with a systematic overview of the regulatory requirements that must be observed when developing and placing AI-based medical software on the market in Europe.
In addition to EU MDR 2017/745, numerous other EU regulations and national regulations apply to the development, approval and documentation of digital medical devices with AI components, the sheer number of which can make even well-informed manufacturers and developers lose track. In addition, various legal deadlines expire or have already expired by 2031, with further requirements to be met with each deadline.
For example, the AI Act is already legally binding and applicable, while the regulations on the European Health Data Space (EHDS) have several transitional periods. It is also often unclear what exactly the legislator means by a digital medical device and how an AI component affects the requirements. It should also be borne in mind that digital products that become part of a critical infrastructure must comply with the NIS2 Directive or the KRITIS Umbrella Act. This seminar systematically guides you through the requirements for digital medical devices with AI components in the regulatory role of manufacturer and contract developer. It provides you with a structured approach on how to comply with and apply the current and future regulations.
The development and marketing of digital medical devices with AI components is subject to numerous European regulations. In addition to the EU Medical Device Regulation (MDR), the AI Act, data protection requirements (GDPR) and standards such as IEC 62304, ISO 14971 and ISO/IEC 42001 are increasingly coming into focus.
Why Should You Attend
You should attend this webinar to understand, what are the changes to the previous ISO 14971 and how to implement the changes in your risk management file in a simple and quick way. Your implementation time can be shorter with a good plan and approach and need smart ideas to reach the right level to pass the expectation by your certification company or notified body.
Who Should Attend:
Key Topics Covered:
What is a digital medical device with an AI component?
Where can the requirements for digital medical devices be found in the EU MDR 2017/745?
which other EU regulations and EU directives apply?
Which mandatory harmonized standards apply?
How do the various regulations interact and what impact does this have on the development and approval process and product documentation?
Transitional periods
Speakers:
Prof. Dr. h.c. Frank Stein
Senior Medical Device Expert
Nemius Consulting GmbH
Dr. h.c. Frank Stein, medical engineer, medical engineering experience since 25 years, clinical and research experience in cardiac surgery and cardiology, industrial experience in ophthalmology, neurology, traumatology and dental implants, active implants, active devices, international project and regulatory consulting experience in Europe, North-America, Asia, Australia, Arabic Countries, Latin-America.
For more information about this training visit https://www.researchandmarkets.com/r/huehr2
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Fonte: Business Wire