Medical device CE marking

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

2021-02

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

IVDR:

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

Source: NANDO database