2024-10
At the moment there are 50 notified bodies designated to perform audits according the MDR:
- Germany: TÜV NORD CERT GmbH, TÜV-SUD, DEKRA Certification – Germany, TÜV Rheinland, DQS, MEDCERT, MDC, SLG Prüf und Zertifizierungs GmbH, Berlin Cert Prüf- und Zertifizierstelle für Medizinprodukte GmbH, SZUTEST Konformitätsbewertungsstelle GmbH
- Italy: IMQ, Instituto Superiore di Sanita’, ICIM S.P.A., ITALCERT SRL, Kiwa Cermet Italia S.P.A., Eurofins Product Testing Italy S.r.l., CERTIQUALITY S.r.l., TUV Rheinland Italia SRL, Bureau Veritas Italia S.P.A. , Ente Certificazione Macchine SRL, MTIC InterCert
- Netherlands: DEKRA Certification The Netherlands, Kiwa Dare B.V., BSI-NL, Scarlet NB
- Other: QMD Services GmbH (Austria), SGS Belgium NV (Belgium), UDEM Adriatic d.o.o. (Croatia), HTCert (Cyprus), Institut pro Testovani a Certifikaci, a.s. and CESKY METROLOGICKY INSTITUT (Czech Republic), TÜV SÜD Danmark (Denmark), Eurofins Expert Services Oy and SGS FIMKO OY (Finland), GMED and AFNOR Certification (France), CE Certiso Orvos, and NEOEMKI (Hungary), NSAI (Ireland), DNV (Norway), TUV NORD Polska and Polskie Centrum Badan I Certyfikacji S.A. (Poland), 3EC (Slovakia), Slovenian Institute of Quality and Metrology (Slovenia), Centro Nacional de Certificacion de Productos Sanitarios (Spain), Intertek and RISE (Sweden), UDEM, Notice Belgelendirme and Kiwa Belgelendirme Hizmetleri (Turkey)
The current status of NBs under the IVDR is 13:
- Austria: QMD Services GmbH
- Finland: Sertio Oy, Eurofins
- France: GMED SAS
- Germany: DEKRA Certification – Germany, TÜV Rheinland, TÜV-SUD, MDC Medical Device Certification GmbH
- Ireland: National Standards Authority of Ireland (NSAI)
- Italy: Instituto Superiore di Sanita’
- Netherlands: DEKRA Certification B.V., BSI-NL
- Slovakia: 3EC International a.s.
Source: NANDO database
