# Commission Implementing Regulation (EU) No 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices (Text with EEA relevance), 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:

Extent: E+W+S+N.I.

4.1.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.

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Source: https://www.legislation.gov.uk/eur/2013/920/annex/I/division/4 (the official version)
Page: https://openlegislation.uk/eu-regulation-2013-920/annex-I/division-4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.

