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MDCG 2019-3 Interpretation of Article 54(2)b rev 1
Guidance on Content of the certificates, voluntary certificate transfers
Best practice guidance on designation and notification of conformity assessment bodies (NBOG BPG 2017-1)
Application form to be submitted by a conformity assessment body when applying for designation as notified body under the medical devices Regulation (MDR) (NBOG F 2017-1)
Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR) (NBOG F 2017-3)
Application form to be submitted by a conformity assessment body when applying for designation as notified body under the in vitro diagnostic devices Regulation (IVDR) (NBOG F 2017-2)
Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/746 (IVDR) (NBOG F 2017-4)
Preliminary assessment review template (MDR) (NBOG F 2017-5)
Review of qualification for the authorisation of personnel (MDR) (NBOG F 2017-7)
Review of qualification for the authorisation of personnel (IVDR) (NBOG F 2017-8)
Preliminary assessment review template (IVDR) (NBOG F 2017-6)
Guidance papers on accreditation
CERTIF 2013-06 REV 2 – Notification and the peer evaluation status of a national accreditation body
CERTIF 2012-02 REV4 – Activities of Accreditation bodies that are not accreditation
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