Third-Party Conformity Assessment – Annex VII
When Is It Required?
An assessment by a Notified Body is only required for certain high-risk systems, in particular remote biometric identification and certain law enforcement AI.
Procedure (Annex VII)
The procedure comprises the assessment of:
- Quality Management System — comprehensive review of the QMS by the Notified Body
- Technical Documentation — review for completeness and plausibility
- Sample Testing — tests on the system itself
The Notified Body issues a certificate upon a positive outcome.
BAUER GROUP Position
Systems requiring an Annex VII assessment are automatically a No-Go for the EU market. The effort involved (Notified Body costs, preparation time, recurring audits) is disproportionate for the BAUER GROUP business model.