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Commission Implementing Regulation (EU) No 920/2013Show full title
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)
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2.The second paragraph of Section 2 of Annex XI to Directive 93/42/EEC shall be interpreted as including the following elements:U.K.
2.1.
Subcontracting shall be limited to specific tasks. The subcontracting of the auditing of quality management systems or of products related reviews in its entirety is not allowed. The conformity assessment body shall in particular keep internal the review of the qualification and the monitoring of the performance of the external experts, the experts’ assignment to specific conformity assessment activities, and the final review and decision-making functions.
2.2.
Where a conformity assessment body subcontracts specific tasks or consults external experts related to the conformity assessment, it shall have a policy describing the conditions under which subcontracting or the consultation of external experts may take place. Any subcontracting or consultation of external experts shall be properly documented and be subject to a written agreement covering, among others, confidentiality and conflict of interests.
2.3.
The conformity assessment body shall establish procedures for assessing and monitoring the competence of all subcontractors and external experts used.
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