Division 6.1.2.3 Definition of assessment procedures

The assessment procedures are defined in Annex F to this TSI.

Module D may only be chosen where the manufacturer operates a quality system for production, final product inspection and testing, approved and surveyed by a notified body.

Module H2 may only be chosen where the manufacturer operates a quality system for design, production, final product inspection and testing, approved and surveyed by a notified body.

The conformity and suitability for use assessment shall cover the phases and characteristics as indicated by X in the Table 1 of Annex D to this TSI.