MDR认证注册、FDA认证注册咨询认证机构，在医疗器械欧盟MDR认证、美国FDA注册咨询领域深耕多年，经验丰富、认证。精英MDR认证团队，为您提供从医疗器械MDR临床到上市后跟踪一条龙式服务。
2022年5月30日，NANDO更新了医疗器械法规相关的公告机构名单.
以下机构目前获得了MDR公告机构授权：
3EC International a.s. (Slovakia) – NB2265(MDR)
BSI Group The Netherlands B.V.(Netherlands) – NB2797 (MDR)
CE Certiso és Kórháztechnikai Ellen
ő
rz
és Tanúsító Kft. (Hungary) – NB2409 (MDR)
CERTI S.r.l. (Italy) – NB0546 (MDR)
DEKRA Certification GmbH (Germany) – NB0124(MDR)
DEKRA Certification B.V. (Netherlands) – NB0344(MDR)
DNV Product Assurance AS (Norway) – NB2460(MDR)
DQS Medizinprodukte GmbH (Germany) –NB0297 – (MDR)
Eurofins Expert Services Oy (Finland) – NB0537(MDR)
Eurofins Product Testing S.r.l. (Italy) – NB0477(MDR)
GMED SAS (France) – NB0459 (MDR)
IM ITALIANO DEL MARCHIO DIQUALITÀ S.P.A. (Italy) –NB0051 (MDR)
Intertek Medical Notified Body AB (Sweden)– NB2862 (MDR)
Istituto Superiore di Sanita (Italy) – NB0373(MDR)
ITALCERT SRL (Italy) – NB0426 (MDR)
Kiwa Cermet Italia S.P.A. (Italy) – NB0476(MDR)
Kiva Dare B.V. (Netherlands) – NB1912 (MDR)
MDC Medical Device Certification GmbH(Germany) – NB0483(MDR)
MEDCERT Zertifizierungs-undPrüfungsgesellschaft für die MedizinGmbH (Germany) – NB0482 (MDR)
National Standards Authority of Ireland /NSAI (Ireland) – NB0050(MDR)
SGS Belgium NV (Belgium) – NB1639 (MDR)
SGS FIMKO OY (Finland) – NB0598 (ex-0403) –(MDR)
Slovenian Institute of andMetrology / SIQ (Slovenia) –NB1304 (MDR)
TÜV NORD CERT GmbH (Germany) – NB0044 (MDR)
TÜV NORD Polska Sp. z o.o (Poland) – NB2274(MDR)
TÜV Rheinland Italia SRL (Italy) – NB1936 (MDR)
TÜV Rheinland LGA Products GmbH (Germany) –NB0197 (MDR)
TÜV SÜD Product Service GmbH (Germany) – NB0123(MDR)
UDEM Adriatic d.o.o. (Croatia) – NB2696 (MDR)
EU Notified Bodies designated underthe EU IVDR (2017/746)
以下机构获得了IVDR的授权：
3EC International (Slovakia) – NB2265 (IVDR)
BSI (Netherlands) – NB2797 (IVDR)
DEKRA Certification (Germany) – NB0124 (IVDR)
DEKRA Certification (Netherlands) – NB0344(IVDR)
GMED SAS (France) – NB0459 (IVDR)
TÜV Rheinland LGA (Germany) NB0197 – (IVDR)
TÜV SÜD (Germany) – NB0123 (IVDR)
以下机构已经基本完成了机构资格审核，即将获得NB资格
Berlin Cert – NB0633 – MDR (IVDR unknown)
ECM Italy – 1282 – MDR only
ICIM SpA – NB0425 – MDR only
PCBC – NB1434– MDR and IVDR
QMD Services – MDR and IVDR
TÜV NORD Polska – NB2274 –MDR only
