MDR
IVDR
Archives: Downloads
2019-6 v4 Q&A: Requirements relating to notified bodies
2022-15 Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDD
Notified Body
2021-22 Rev.1 Clarification on first certification – IVDR
(EU) 2017/746
Notified Body
Article 48(6)
New European Manual on Borderline and Classification for medical devices and IVDs
MDR
IVDR
MDCG 2022-14 Notified body capacity and availability of medical devices and IVDs
MDR
IVDR
MDCG 2022-13 Designation, re-assessment and notification of conformity assessment bodies and notified bodies
MDR
IVDR