- Status
- In Force
- Penalty ceiling
- Regulated
Does it bind you?
Business-side roles with duties under this instrument.
Conformity Assessment Body5
Other Acts binding the same actors
If a role above is yours, these are the other instruments that most often bind it.
Conformity Assessment Body — also bound by 47 other Acts
Lifts Regulations 2016
28 duties
Radio Equipment Regulations 2017
27 duties
Explosives Regulations 2014
22 duties
What it requires
Regulations creating concrete business duties or carrying penalties, grouped as the instrument is structured. Titles link to the source text — blue means you’re leaving for legislation.gov.uk.
uri:annex/i/division/2
uri:annex/i/division/2
Regulated
- Limit subcontracting of certification work and keep control of key decisionsConformity Assessment Body
uri:annex/i/division/3
uri:annex/i/division/3
Regulated
- Maintain resources, processes, and qualified personnel for medical device conformity assessmentConformity Assessment Body
uri:annex/i/division/4
uri:annex/i/division/4
Regulated
- Take out liability insurance covering your conformity assessment activitiesConformity Assessment Body
uri:annex/i/division/5
uri:annex/i/division/5
Regulated
- Keep confidential information confidential with documented proceduresConformity Assessment Body
s.art003
Procedure for the designation of approved bodies
Regulated
- Use correct application form and submit electronic copy when applying to be an approved bodyConformity Assessment Body
29 other provisions — procedural and definitional
s.annex ii para.1
Designating authority: …
s.annex ii para.10
E-mail: …
s.annex ii para.11
Telephone: …
s.annex ii para.12
Legal form of the conformity assessment body: …
s.annex ii para.13
Company registration number: …
s.annex ii para.14
At company register: …
s.annex ii para.15
…
s.annex ii para.16
…
s.annex ii para.17
The following documents shall be added. In case of extension...
s.annex ii para.18
Item/issue Corresponding Annex I section Attachment number + Reference(Section/page) ORGANISATIONAL...
s.annex ii para.19
Name and signature of an authorised representative of the applicant...
s.annex ii para.2
Name of the applying conformity assessment body: …
s.annex ii para.3
Previous name (if applicable): …
s.annex ii para.4
Approved Body number (if applicable): …
s.annex ii para.5
Address: …
s.annex ii para.6
…
s.annex ii para.7
…
s.annex ii para.8
…
s.annex ii para.9
Contact person: …
s.art001
Definitions
s.art001
In this Regulation, any reference to Annex 8 to Directive...
s.art002
Interpretation of designation criteria
s.art004
Extension and renewal of designation
s.art005
Surveillance and monitoring
s.art006
Investigation of the competence of an approved body
s.art007
Exchange of experience on designation and supervision of conformity assessment bodies
s.art008
Operating of designating authorities
s.art009
Cooperation with accreditation bodies
s.art010
Entry into force and date of application
Duty extraction and severity labels are Guvnor’s analysis of the instrument, not the instrument itself. Always verify against the linked source text.