Medical device CE marking

Eurofins Expert Services Oy 20th NB under the MDR

2021-04

MDR:

On April 7, 2021, the 20th Notified Body has been designated under the MD Regulation and included in the European Commission NANDO database: 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.

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 still 4, after removal of BSI UK as per January 1st, 2021.

Source: NANDO database