"AI in Medical Devices" was the topic of the event on July 5 and was discussed widely in Berlin. Currently, the AI Act is being under negotiation in Brussels and this is exactly that time when reasonable questions of AI software manufacturers need to be taken into attention, otherwise the huge opportunity for faster and more accurate diagnostics 'Made in Germany' will be lost.

The most burning questions are:

• Which regulatory requirements arise for AI use from the Medical Device Regulation?

• What will manufacturers have to face with the AI Act from Brussels?

Steffen Buchholz 8Department of Medical Device Safety at the German Federal Ministry of Health) provided insights into the negotiations on the Brussels AI Act.

Another program topic dealt with the certification process. Juri Rohde from FUSE-AI was invited by Bitkom as guest speaker to share his expertise on the certification process and to pass on tips and tricks.

The conclusion of the participants

• Unfortunately, anyone who wants to have their medical device certified has to wait in line. Due to the small number of notified bodies, there are long waiting times.

• Forewarned is forearmed. Documentation will be easier if there are quality assurance structures in the company right from the start.

• The implementation of the AI Act leaves many questions unanswered. Overregulation and significant cost increases may not be excluded.

Are you interested in being advised about certification? We are looking forward to offering you an in-house workshop, feel free to contact Juri Rohde!

Juri Rohde
+ 49 40 - 450 318 - 34
juri.rohde@fuse-ai.de