Medical device CE marking

25th NB under the MDR designated: SGS Belgium NV

2021-11

MDR:

The 25th Notified Body under the MDR was designated and included in the NANDO database: SGS Belgium NV (NB #1639).

Previously designated in 2021: CERTIQUALITY S.r.l. (NB #0546), TUV Rheinland Italia SRL (NB# 1936), Eurofins Product Testing Italy S.r.l. (NB #0477), Kiwa Cermet Italia S.P.A. (NB #0476), Eurofins Expert Services Oy (NB# 0537) in Finland, Instituto Superiore di Sanita’ (ISS) (NB# 0373) in Italy and SGS FIMKO OY (NB# 0598 / ex-0403) in Finland.

Source: NANDO database

IVDR:

On August 19, the 6th Notified Body under the IVDR was designated and included in the NANDO database: GMED SAS (NB #0459) in France.

The other 5 are:
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