Conformity Assessment
For high-risk AI systems, a conformity assessment is mandatory before the system may be placed on the market. We guide the full process, from technical documentation to CE marking.
The process
Classification check
We confirm the risk classification of your AI system and determine which requirements apply based on Annexes II and III.
Technical documentation
We prepare the full technical documentation per Annex IV: system description, design, development process, validation and monitoring.
Quality management system
Setup of the QMS per Article 17: procedures for design, testing, risk management, data quality and post-market monitoring.
Risk management & data governance
Risk management system (Art. 9), data governance procedures (Art. 10), transparency (Art. 13) and human oversight (Art. 14).
Declaration of conformity & CE marking
Guidance on drafting the EU declaration of conformity and applying the CE marking to your AI system.
What you get
Examples of high-risk AI systems
For whom?
AI providers
Organizations that develop or place high-risk AI systems on the European market. CE marking is mandatory.
AI deployers
Organizations that deploy high-risk AI in their processes. You are responsible for correct use and monitoring.
Importers and distributors
Parties importing AI systems from outside the EU. You must verify conformity before resale.
Frequently asked questions
When does the obligation for high-risk AI apply?
The requirements for high-risk AI systems apply from August 2, 2026. Conformity assessment must be completed before that date for systems on the market.
Can we perform the conformity assessment ourselves?
For most high-risk systems, self-assessment (internal conformity assessment) is permitted. For AI in biometric identification, an external notified body is required. We guide both processes.
How much does a conformity assessment cost?
The investment depends on the complexity of your AI system, availability of documentation and whether a QMS already exists. In the intake we provide a concrete quote.
What if our system is already live?
Existing high-risk AI systems that remain on the market after August 2, 2026 must also comply. We help with retroactively completing the conformity assessment.
Do you have a high-risk AI system?
In a free intake we assess whether your system qualifies as high-risk and what is needed for conformity.
Book your free intake