Medical device CE marking

Instituto Superiore di Sanita’ (ISS) 19th NB under the MDR



On February 16, 2021, the 19th Notified Body has been designated under the MD Regulation and included in the European Commission NANDO database: Instituto Superiore di Sanita’ (ISS) (NB# 0373) in Italy. The 18th Notified Body was officially designated on January 9, 2021: SGS FIMKO OY (NB# 0598 / ex-0403), Finland.

This follows the removal of BSI UK (NB# 0086) from NANDO on 1 January 2021 as a direct consequence of the UK leaving the European Union and the designation of UDEM Adriatic d.o.o. (NB# 2696) on December 15, 2020.

Source: NANDO database


The current status of NBs under the IVDR is 4, after removal of BSI UK as per January 1st, 2021.

Source: NANDO database