Version detected , Modified +24 −6§
no amending act named
Explanation, written by a model and checked against the cited text
In section 4.5.2(a), the sampling plan requirement was reworded so that it now refers to ensuring that the entire range of devices covered by the certificate is sampled over the period of validity of the certificate, whereas the earlier text referred to ensuring that all devices covered by the certificate are sampled over that period.
The bullet listing this sampling-plan requirement now ends with 'and' before the following bullet on selecting and assigning personnel, a connector that was absent in the earlier version.
Cited: Annex VII, v1 (external, EUR-Lex) · Annex VII, v2 (external, EUR-Lex)
v1 is the previous version, v2 this one.
Text from EUR-Lex, before and after
Previous version 32017R0746 → this version, detected 12 August 2026 02017R0746-20170505
ANNEX VII
REQUIREMENTS TO BE MET BY NOTIFIED BODIES
1. ORGANISATIONAL AND GENERAL REQUIREMENTS
1.1. Legal status and organisational structure
1.1.1. Each notified body shall be established under the national law of a Member State, or under the law of a third country with … 5,029 unchanged words … for class B and class C devices, a sampling plan for the assessment of technical documentation as referred to in Annexes II and III covering the range of such devices covered by the manufacturer's application. That plan shall ensure that all the entire range of devices covered by the certificate are is sampled over the period of validity of the certificate,
and
select and assign appropriately qualified and authorised personnel for conducting the individual audits. The respective roles, responsibilities and authorities of the team members shall be clearly defined and documented.
(b) Based on the audit programme it has drawn up, the notified … 2,886 unchanged words … in question shall use the same methods and principles as for the initial certification decision. If necessary, separate forms shall be established for re-certification taking into account the steps to be taken for certification, such as application and application review.