Dear All,
A new NB had lastly been notified under EU Regulation 2017-745, which is GMED (France), thus becoming the 16th NB designated by NANDO, with designation NB 0459.
You’ll find here attached the PDF list of its detailed framework under MDR.
As well, the today’supdated-lists of NBs under MDR and IVDR and their detailed framework under these regulations too in PDF format.
NBs list is otherwise shortly summarized as follows :
LEGISLATION: REGULATION (EU) 2017/746 ON IVD MEDICAL DEVICES - 4 NBs
NB 0086 BSI Assurance UK Ltd United Kingdom
NB 2797 BSI Group The Netherlands B.V. Netherlands
NB 0124 DEKRA Certification GmbH Germany
NB 0123 TÜV SÜD Product Service GmbH Zertifizierstellen Germany
List and detail also available from https://ec.europa.eu/growth/tools-d...
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LEGISLATION: REGULATION (EU) 2017/745 ON MEDICAL DEVICES - 16 NBs
NB 0086 BSI Assurance UK Ltd United Kingdom
NB 2797 BSI Group The Netherlands B.V. Netherlands
NB 2409 CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft. Hungary
NB 1912 DARE!! Services B.V. Netherlands
NB 0344 DEKRA Certification B.V. Netherlands
NB 0124 DEKRA Certification GmbH Germany
NB 2460 DNV GL Presafe AS Norway
NB 0297 DQS Medizinprodukte GmbH Germany
NB 0459 GMED France
NB 0051 IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A. Italy
NB 2862 Intertek Medical Notified Body AB Sweden
NB 0483 MDC MEDICAL DEVICE CERTIFICATION GMBH Germany
NB 0482 MEDCERT ZERTIFIZIERUNGS- UND PRÜFUNGSGESELLSCHAFT FÜR DIE MEDIZIN GMBH Germany
NB 0050 National Standards Authority of Ireland (NSAI) Ireland
NB 0197 TÜV Rheinland LGA Products GmbH Germany
NB 0123 TÜV SÜD Product Service GmbH Zertifizierstellen Germany
List and detail also available from https://ec.europa.eu/growth/tools-d...
Best regards,
MME Team
