Division 4 Sections 6 of Annex 8 to Directive 90/385/EEC and of Annex XI to Directive 93/42/EEC shall be interpreted as including the following elements:

The conformity assessment body shall take out appropriate liability insurance corresponding to the conformity assessment activities for which it is notified, including the possible suspension, restriction or withdrawal of certificates, and the geographic scope of its activities, unless liability is assumed by the State under domestic legislation or the Member State itself carries out the inspections directly.