- Latest available (Revised)
- Original (As adopted by EU)
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)
You are here:
What Version
More Resources
Revised version PDFs
- Revised 19/05/20200.28 MB
Legislation originating from the EU
When the UK left the EU, legislation.gov.uk published EU legislation that had been published by the EU up to IP completion day (31 December 2020 11.00 p.m.). On legislation.gov.uk, these items of legislation are kept up-to-date with any amendments made by the UK since then.
This item of legislation originated from the EU
Legislation.gov.uk publishes the UK version. EUR-Lex publishes the EU version. The EU Exit Web Archive holds a snapshot of EUR-Lex’s version from IP completion day (31 December 2020 11.00 p.m.).
Status:
This is the original version as it was originally adopted in the EU.
This legislation may since have been updated - see the latest available (revised) version
2.The second paragraph of Section 2 of Annex XI to Directive 93/42/EEC shall be interpreted as including the following elements:
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.
Options/Help
Print Options
PrintThe Whole Regulation
PrintThe Whole Annex
PrintThis Division only
Legislation is available in different versions:
Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.
Original (As adopted by EU): The original version of the legislation as it stood when it was first adopted in the EU. No changes have been applied to the text.
Opening Options
Different options to open legislation in order to view more content on screen at once
More Resources
Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:
- the original print PDF of the as adopted version that was used for the EU Official Journal
- lists of changes made by and/or affecting this legislation item
- all formats of all associated documents
- correction slips
- links to related legislation and further information resources
More Resources
Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:
- the original print PDF of the as adopted version that was used for the print copy
- correction slips
Click 'View More' or select 'More Resources' tab for additional information including:
- lists of changes made by and/or affecting this legislation item
- confers power and blanket amendment details
- all formats of all associated documents
- links to related legislation and further information resources
All content is available under the Open Government Licence v3.0 except where otherwise stated. This site additionally contains content derived from EUR-Lex, reused under the terms of the Commission Decision 2011/833/EU on the reuse of documents from the EU institutions. For more information see the EUR-Lex public statement on re-use.