How to CE Mark Your AI Software Medical Device | Notified Body Insights (MDR & AI Act)

Описание: Artificial intelligence is rapidly transforming healthcare, but bringing an AI based medical device to the European market requires a clear regulatory strategy.

In this webinar we discuss how to CE mark an AI software medical device under the EU Medical Device Regulation (MDR 2017/745) with direct insights from a Notified Body.

The session explores what reviewers actually evaluate during conformity assessment and highlights the most frequent pitfalls that delay approval for AI based medical devices.

This discussion includes perspectives from experts working directly within the Notified Body environment as well as real experience supporting manufacturers developing AI driven medical technologies.

What You Will Learn

In this webinar we cover:

• Frequent classification mistakes in AI software medical device submissions
• Common gaps in technical documentation such as risk management, cybersecurity, and GSPR mapping
• When Article 61.1 or Article 61.10 may be used for clinical evidence
• Expected performance and safety metrics for AI based medical devices
• How to monitor AI behaviour after CE marking including bias, drift, and updates
• Which software modifications require a new Notified Body review
• Interaction between the MDR and the upcoming European AI Act
• Realistic timelines and regulatory costs for startups and SMEs

Speakers

Dr Engin Çamer
Clinical Unit Manager
SZUTEST GmbH – Notified Body 2975

Alireza Sheikhi Nasrabadi
Lead Auditor and Product Reviewer
SZUTEST GmbH – Notified Body 2975

Dr Hatem Rabeh
Medical Doctor and Biomedical Engineer
Clinical Evaluation Expert
Founder of Clinical Evaluation Navigator

Dr Rabeh has supported multiple medical device startups and established companies with clinical evaluation strategies, SOTA reports, and regulatory documentation required for MDR compliance.

Topics Covered

AI medical devices
CE marking MDR
Software as a medical device
MDR 2017/745
Clinical evaluation
Risk management ISO 14971
Cybersecurity medical devices
AI Act Europe
Notified Body review
Technical documentation MDR