Purpose
Establish a structured readiness program for AI-enabled products seeking CE Marking under applicable EU directives/regulations (e.g., MDR, LVD, EMC).
Scope
Applies to every AI component embedded in CE-marked products or placed on the EU market, including hardware/software combinations, medical devices, industrial systems, and consumer electronics.
- Standalone software classified as medical device (SaMD)
- AI subsystems embedded in machinery or safety components
- Consumer devices with AI features impacting safety/performance
Definitions
- Technical Documentation (Technical File): Evidence package demonstrating conformity with EU directives/regulations.
- Notified Body: EU-accredited organization assessing conformity for specific directives.
- Post-Market Surveillance (PMS): Ongoing collection of data after product placement on the market.
Policy
All AI-enabled products must maintain complete CE technical documentation, risk management files, and PMS procedures. Regulatory Affairs leads liaison with notified bodies and ensures conformity assessments are scheduled and executed.
Roles and Responsibilities
Regulatory Affairs Director owns the CE readiness plan and interface with notified bodies. Product Engineering supplies design inputs, testing evidence, and change logs. Quality ensures risk management and PMS processes align with ISO 13485/ISO 14971 where applicable.
Procedures
CE readiness activities include:
- Identify applicable directives/regulations and harmonized standards.
- Compile technical documentation (architecture, risk management, validation).
- Conduct gap analysis against directive essential requirements and AI-specific obligations.
- Engage notified body (if required) and prepare audit schedules.
- Establish PMS and vigilance reporting for AI components.
- Document change-control procedures linked to CE obligations.
Exceptions
No exceptions for CE-marked products. Temporary deferment requires executive approval and must not involve market placement until conformity is proven.
Review Cadence
Regulatory Affairs reviews CE readiness status quarterly, updating gap assessments and PMS evidence. Major product changes trigger immediate review.
References
- EU Medical Device Regulation (MDR) 2017/745
- Machinery Directive, Low Voltage Directive, EMC Directive (as applicable)
- Internal documents: CE Technical File Checklist, PMS & Vigilance SOP, Notified Body Engagement Plan