Version detected , Modified +21 −6§
no amending act named
Explanation, written by a model and checked against the cited text
In section 4.5.2(a), the description of the sampling plan's coverage requirement was reworded from ensuring that all devices covered by the certificate are sampled over the certificate's period of validity to ensuring that the entire range of devices covered by the certificate is sampled over that period.
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 32017R0745 → this version, detected 12 August 2026 02017R0745-20170505
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 … 5,055 unchanged words … for class IIa and class IIb 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 … 3,054 unchanged words … notified body 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 taken for certification such as application and application review.