EU-AIA-46-01
Conformity
46 — Derogation from conformity assessment procedure
Time-limited derogation authorization by market surveillance authority
Description
Full Analysis & Evidence Requirements
Sign in to view the full obligation text, AI-generated applicability analysis, evidence checklists, and compliance mapping.
Sign In to ViewRelated Obligations
EU-AIA-46-02
Requirement
Obligation to request authorisation after urgent use without prior approval
EU-AIA-46-03
Requirement
Immediate cessation and discarding of outputs upon refusal of authorisation
EU-AIA-46-04
Conformity
Authorisation conditional on compliance with Section 2 requirements
EU-AIA-46-05
Reporting
Notification of authorisation to Commission and other Member States
EU-AIA-46-06
Monitoring
Deemed justification absent objection within 15 days
EU-AIA-46-07
Requirement
Commission obligation to consult and decide on contested authorisations
EU-AIA-46-08
Requirement
Withdrawal of authorisation found unjustified by Commission
EU-AIA-46-09
Conformity
Limitation of derogations for products under Annex I Section A harmonisation legislation
Map this obligation to your AI systems
ReguLume automatically maps regulatory obligations to your system inventory, identifies compliance gaps, and generates remediation plans.
Get Started