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Notified Body - Medical Device CE Marking
A notified body is an organization that has been accredited by an EU Member State to conduct a conformity assessment under the relevant EU Directives and issue CE certificate. After certification manufacturers can affix CE Mark on their Medical device and are free to market their devices in all EU Member states. Manufacturers can choose any notified body for conformity assessment (audit) regardless of which country the notified body is accredited.
Medical device CE Marking consists of two stage audit. Generally the stage one audit is offsite - depends on the device's intended use and risk. Stage two audit is performed at the facility against ISO 13485 compliance. Audit duration and number of auditors are determined by the notified body based on device class and risk involved. Notified bodies are also conducting unannounced audits to confirm the quality system compliance.
List of Notified bodies accredited for Medical Device CE Marking
NB Number |
Notified Body Name |
Country |
NB 0044 |
TUV NORD CERT GmbH |
Germany |
NB 0050 |
National Standards Authority of Ireland (NSAI) |
Ireland |
NB 0051 |
IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITA S.P.A. |
Italy |
NB 0068 |
IRCM ISTITUTO DI RICERCHE E COLLAUDI MASINI S.R.L. |
Italy |
NB 0086 |
BSI |
United Kingdom |
NB 0088 |
LLOYD'S REGISTER QUALITY ASSURANCE LTD |
United Kingdom |
NB 0120 |
SGS United Kingdom Limited |
United Kingdom |
NB 0123 |
TUV SUD Product Service GmbH Zertifizierstellen |
Germany |
NB 0124 |
DEKRA Certification GmbH |
Germany |
NB 0197 |
TUV Rheinland LGA Products GmbH |
Germany |
NB 0297 |
DQS Medizinprodukte GmbH |
Germany |
NB 0318 |
AGENCIA ESPANOLA DE MEDICAMENTOS Y PRODUCTOS SANITARIOS |
Spain |
NB 0344 |
DEKRA Certification B.V. |
Netherlands |
NB 0373 |
ISTITUTO SUPERIORE DI SANITA |
Italy |
NB 0402 |
SP Sveriges Tekniska Forskningsinstitut |
Sweden |
NB 0408 |
TUV AUSTRIA SERVICES GMBH |
Austria |
NB 0413 |
INTERTEK SEMKO AB |
Sweden |
NB 0426 |
ITALCERT SRL |
Italy |
NB 0434 |
DNV GL Business Assurance Norway AS |
Norway |
NB 0459 |
Laboratoire national dessais / G-MED |
France |
NB 0470 |
NEMKO AS |
Norway |
NB 0473 |
AMTAC CERTIFICATION SERVICES LTD |
United Kingdom |
NB 0476 |
KIWA CERMET ITALIA S.P.A. |
Italy |
NB 0477 |
Eurofins Product Testing Italy S.r.l. |
Italy |
NB 0481 |
ECM-ZERTIFIZIERUNGSGESELLSCHAFT FUR MEDIZINPRODUKTE IN EUROPA MBH |
Germany |
NB 0482 |
MEDCERT ZERTIFIZIERUNGS |
Germany |
NB 0483 |
MDC MEDICAL DEVICE CERTIFICATION GMBH |
Germany |
NB 0494 |
SLG PRUF UND ZERTIFIZIERUNGS GMBH |
Germany |
NB 0499 |
SOCIETE NATIONALE DE CERTIFICATION ET D HOMOLOGATION S.A.R.L. (SNCH) |
Luxembourg |
NB 0535 |
BSI Group Deutschland GmbH |
Germany |
NB 0537 |
VTT Expert Services Oy |
Finland |
NB 0543 |
Presafe Denmark A/S |
Denmark |
NB 0546 |
CERTIQUALITY S.R.L. |
Italy |
NB 0598 |
SGS FIMKO OY |
Finland |
NB 0633 |
BERLIN CERT PRUF |
Germany |
NB 0636 |
PRUFSTELLE FUR MEDIZINPRODUKTE GRAZ |
Austria |
NB 0653 |
NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY |
Greece |
NB 0805 |
THERAPEUTIC GOODS ADMINISTRATION |
Australia |
NB 0843 |
UL INTERNATIONAL (UK) LTD |
United Kingdom |
NB 1008 |
TUV Rheinland InterCert Muszaki Felugyeleti es Tanusito Korlatolt Felelossegu Tarsasag |
Hungary |
NB 1011 |
Orszagos Gogyszereszeti es Elelmezes |
Hungary |
NB 1014 |
ELEKTROTECHNICKY ZKUSEBNI USTAV, s.p. |
Czech Republic |
NB 1023 |
INSTITUT PRO TESTOVANI A CERTIFIKACI, a. s. |
Czech Republic |
NB 1250 |
SCHWEIZERISCHE VEREINIGUNG FUR QUALITATS- UND MANAGEMENTSYSTEME |
Switzerland |
NB 1254 |
QS Zurich AG |
Switzerland |
NB 1293 |
EVPU a.s. |
Slovakia |
NB 1370 |
BUREAU VERITAS ITALIA S.P.A. |
Italy |
NB 1434 |
POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. |
Poland |
NB 1639 |
SGS Belgium NV |
Belgium |
NB 1783 |
TURKISH STANDARDS INSTITUTION (TSE) |
Turkey |
NB 1912 |
DARE!! Certifications |
Netherlands |
NB 1936 |
TUV Rheinland Italia SRL |
Italy |
NB 1979 |
SGS Hungaria Minosegellenorzo, Kereskedelmi es Szolgaltato Kft |
Hungary |
NB 1984 |
Kiwa Meyer Belgelendirme Hizmetleri A.S. |
Turkey |
NB 2138 |
Alberk QA Uluslararasi Teknik Kontrol ve Belgelendirme Anonim Sirketi |
Turkey |
NB 2195 |
Szutest Teknik Kontrol ve Belgelendirme Hizmetleri Ticaret Limited Sirketi |
Turkey |
NB 2265 |
3EC International a.s. |
Slovakia |
NB 2282 |
DQS Polska Sp. z o.o |
Poland |
NB 2292 |
UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi Sanayi ve Ticaret Limited Sirketi |
Turkey |
NB 2409 |
CE Certiso Orvos- es Korhaztechnikai Ellenorzo es Tanuusito Kft. |
Hungary |
The above list is for reference only, the accreditation status may change, please visit European Commission website for current status.
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