uri:annex/i/division/2
- Limit subcontracting of certification work and keep control of key decisions
Retained EU Law
2013
United Kingdom
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)
At a glance
What's here
5 compliance obligations
What this Act requires
Sections that create concrete duties on businesses or carry penalties. Procedural and definitional sections are folded into the “Browse other sections” expander at the bottom of each group. Click any section title to read the source text on legislation.gov.uk.
uri:annex/i/division/3
- Maintain resources, processes, and qualified personnel for medical device conformity assessment
uri:annex/i/division/4
- Take out liability insurance covering your conformity assessment activities
uri:annex/i/division/5
- Keep confidential information confidential with documented procedures
Procedure for the designation of approved bodies
- Use correct application form and submit electronic copy when applying to be an approved body
Browse 29 other sections — procedural / definitional / commencement
Designating authority: …
E-mail: …
Telephone: …
Legal form of the conformity assessment body: …
Company registration number: …
At company register: …
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The following documents shall be added. In case of extension...
Item/issue Corresponding Annex I section Attachment number + Reference(Section/page) ORGANISATIONAL...
Name and signature of an authorised representative of the applicant...
Name of the applying conformity assessment body: …
Previous name (if applicable): …
Approved Body number (if applicable): …
Address: …
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Contact person: …
Definitions
In this Regulation, any reference to Annex 8 to Directive...
Interpretation of designation criteria
Extension and renewal of designation
Surveillance and monitoring
Investigation of the competence of an approved body
Exchange of experience on designation and supervision of conformity assessment bodies
Operating of designating authorities
Cooperation with accreditation bodies
Entry into force and date of application
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