Need Assistance?

Whitepaper
Medical Devices

BSI Group recommendations for the AI omnibus proposal

BSI Group is providing this position paper in response to the European Commission’s AI Omnibus proposal.

Download Whitepaper

BSI recommendations for the AI omnibus proposal

This whitepaper outlines impacts on NBs’ operations, capacity, effectiveness, and offers recommendations to align the AI Act with existing frameworks.

Removal of dataset testing for Annex I, Section A products.
Single application and assessment procedure for Notified Bodies.
Role of Notified Bodies in GPAI assessments.
Harmonized standards and application dates.
Integrity of Annex I and the new legislative framework.

Insights & Media

Find out more from global experts in healthcare standards

View Insights & Media

Six Reasons You Choose AI Performance from BSI

Read the Blog

Building Trust in High-Risk Biometric AI Systems: Why Accreditation Matters

Read the Blog

AI Governance and Assurance Webinar

Watch the Webinar

AI Algorithm Auditing and Dataset Testing (AA&DT)

Watch the Webinar

Ensuring trust and conformity of AI enabled Medical Devices

Watch the Webinar

AI Machine Learning and Medical Devices

Read the Whitepaper

Contact us

Let's shape your organization's future together

Reach out and see how we can help guide you on your path to sustainable operational success.

Get in touch