Medical device CE marking

Kiwa Cermet Italia S.P.A. 21st NB under the MDR

2021-07

MDR:

On July 15, 2021, the 21st Notified Body under the MDR was designated and included in the NANDO database: Kiwa Cermet Italia S.P.A. (NB #0476) in Italy.

The 20th Notified Body was designated on April 7, 2021: Eurofins Expert Services Oy (NB# 0537) in Finland, the 19th Notified Body was designated on February 16, 2021: Instituto Superiore di Sanita’ (ISS) (NB# 0373) in Italy and the 18th Notified Body on January 9, 2021: SGS FIMKO OY (NB# 0598 / ex-0403), Finland.

Source: NANDO database

IVDR:

The current status of NBs under the IVDR is still 5:

BSI Group The Netherlands B.V. (NB# 2797)
DEKRA Certification B.V. (NB# 0344)
DEKRA Certification GmbH (NB# 0124)
TÜV Rheinland LGA Products GmbH (NB# 0197)
TÜV SÜD Product Service GmbH Zertifizierstellen (NB# 0123)

Source: NANDO database