An upcoming one-hour online webinar will guide developers and manufacturers through the process of CE marking AI-based medical device software under the Medical Device Regulation (MDR). Scheduled for Friday 7 November 2025 at 15:00 – 16:00 CET, the session will bring practical insights from experienced reviewers at SZUTEST Konformitätsbewertungsstelle GmbH, a designated Notified Body, making it highly relevant for professionals in medical technology, regulatory affairs, and quality management.
In this article:
- When and where is the event?
- What topics will be covered?
- Who are the speakers?
- Who should attend?
- FAQ
- Key takeaways
- Disclaimer
- Registration link
When and where is the event?
The webinar takes place on Friday 7 November 2025 from 15:00 to 16:00 Central European Time, which is 9:00 to 10:00 Eastern Standard Time. The session will be hosted online via Microsoft Teams, allowing participants from any location to join.
What topics will be covered?
The session will focus on regulatory and technical aspects that affect CE marking AI medical device software under MDR. Key agenda points include:
- Common classification errors in AI software submissions
- Typical gaps in technical documentation, covering risk management, cybersecurity, and mapping to General Safety and Performance Requirements (GSPR)
- Clarification on using Article 61.1 versus 61.10 for clinical data needs
- Standards for expected performance and safety metrics in AI devices
- Post-market monitoring of AI behaviour including bias, drift, and software updates
- Criteria determining when software changes require a new Notified Body review
- The relationship between MDR requirements and the upcoming EU AI Act
- Realistic timelines and cost considerations for small and medium enterprises
Who are the speakers?
The panel consists of professionals with direct experience in medical device review and evaluation:
- Dr Engin Camer, Clinical Unit Manager, Szutest GmbH (NB 2975)
- Alireza Sheikhi Nasrabadi, Lead Auditor and Product Reviewer, Szutest GmbH (NB 2975)
- Hatem Rabeh, MD, MSc Ing, Clinical Evaluation Expert
Who should attend?
This webinar is intended for regulatory professionals, software developers in the MedTech sector, quality managers, and clinical evaluators working with AI medical devices. It will also be valuable for SMEs preparing submissions for MDR compliance.
FAQ
1. Is the event free of charge?
The source information does not specify fees. Prospective participants should check the registration page for details.
2. Will there be an opportunity to ask questions?
Yes. The webinar will include a live Q&A segment where attendees can engage directly with the speakers.
3. Is prior knowledge of MDR required?
While not mandatory, familiarity with MDR concepts will help participants benefit more from the session.
4. Will the session be recorded?
The event information does not indicate whether a recording will be available.
Key takeaways
This webinar provides a structured overview of practical regulatory considerations for AI-based medical device software seeking CE marking under MDR. The direct involvement of Notified Body experts ensures the content will be relevant for industry stakeholders seeking to avoid delays and ensure compliance.
Disclaimer
This announcement is for informational purposes only. The author has no affiliation with the event organizers.
Registration link
For more information or to book, visit: https://events.teams.microsoft.com/event/9c455233-28f3-4a3f-b76c-53a015414179@8a23ed8b-e339-430b-97f3-0173f61370ec