Artificial Intelligence knocking on your door? The upcoming Artificial Intelligence Act’s Technical Documentation Requirements and how to integrate them into a Medical Device Regulation Submission

Preconference Workshop Description: As the EU Artificial Intelligence Act (AIA) is expected to enter into force in 2024, planning for its implementation should start now. Manufacturers of AI-enabled medical devices will need to shoulder the responsibility of demonstrating conformance to both the Medical Device Regulation (MDR) and the upcoming AIA. This pre-conference session will empower participants to understand the additional technical documentation requirements of the upcoming AIA and how to effectively combine them with an MDR technical documentation submission. Moderators of this session will share their experience from negotiations from Brussels' Trilogues, European technical committees and international working groups. The group will also present example devices and requirements as well as highlight areas that may warrant extra scrutiny from Notified Bodies based on the type of device.

Proposed Preconference Workshop Agenda Outline:

7:30 – 8:30 AM: Networking Breakfast & Welcome for Workshop Registrants

8:30 – 10:30 AM: Workshop Opening & Session Block 1:

1. Brief overview of the EU AI Act trajectory and how it impacts MDR CE marked devices (in application and current)


2. Participant Activity 1 – Requirements of EU Legislative Technical Documentation


3. Technical documentation requirements for both the MDR and EU AI Act


4. GSPRs and State of the Art


5. Declaration of Conformity requirements


6. Participant Activity 2 – Scrutiny of Examples

10:30 – 11:00 AM: Refreshment Break for Preconference Workshop Registrants 

11:00 – 12:30 AM: Workshop Session Block 2:

1. Risk Management and Mitigations


2. Participant Activity 3 – Technical documentation of specific devices

12:30 – 1:30 PM: Lunch & Networking for Preconference Workshop Registrants

1:30 – 3:00 PM: Workshop Session Block 3 and Closing:

1. Scrutiny of Submissions


2. Participant Activity 4- Reviewing Sample Technical Documentation to identify weaknesses and strengths

3:00 – 3:15 PM: Refreshment Break for Preconference Workshop Registrants 

3:15 – 4:00 PM: Questions for Speakers

4:00 PM: All Pre-Conference Workshops adjourn for the day