Providers of high-risk systems under Annex III (excluding critical infrastructure under Annex III, point 2) register in the EU database before placing the system on the market. Annex VIII Section A specifies twelve information items: provider identity and contact details, submitter identity (if different), authorised representative details (if applicable), system trade name and identification, intended purpose description, system status, notified body certificate details, deployment member states, comparable database URLs, additional information URLs, concise data collection description, and electronic instructions for use.

Each item demands preparation. The “description of the intended purpose” must be precise and consistent with AISDP Module 1 wording. The “concise description of data collection means” must be factually accurate without disclosing commercially sensitive detail. The Technical SME prepares the electronic instructions for use in a format suitable for digital publication.

The Conformity Assessment Coordinator completes registration through the Commission’s online platform, with the Technical SME reviewing technical content and Legal counsel reviewing legal content before submission.

Key outputs

• Twelve-item Annex VIII-A registration completed before market placement
• Intended purpose and data collection descriptions consistent with AISDP
• Electronic instructions for use prepared for digital publication
• Module 10 AISDP evidence