Critical class (Annex IV)

Critical products in Annex IV (e.g. smart meter gateways, secure elements): the strictest assessment routes with a notified body.

Critical products are listed in Annex IV and are subject to the strictest conformity assessment routes under Article 47 and Annex VIII, always with third-party involvement. The technical documentation and its traceability are central because the notified body's examination and subsequent surveillance rest on them.

Annex III / IV structure

Annex IV (critical) (Regulation (EU) 2024/2847, Art. 47)

The Regulation's own structure names these 3 items in Annex IV:

• hardware devices with security boxes
• smart meter gateways and other advanced security purpose devices for secure cryptographic processing
• smartcards and similar devices, including secure elements

This is the Regulation's own structure (Regulation (EU) 2024/2847, Annex IV), not an assessment of any specific product. Whether a particular product falls within a named item is the manufacturer's guided questionnaire answer, never an assumption of this site.

Conformity assessment

EU-type examination + conformity based on full quality assurance (Module H), notified body required

Key obligations

• Strictest conformity assessment route under Article 47 and Annex VIII
• Notified body examination of the type and full quality assurance of production
• Annex VII technical documentation is the examination basis; traceability is mandatory
• Regular surveillance by the notified body for the certified type