2023年11月3日,位于土耳其的Notice Belgelendirme, Muayene ve Denetim Hizmetleri Anonim Şirketi(公告机构编号:NB 2764)获得MDR审核资质,该公告机构为土耳其的第1家MDR公告机构,是继挪威的DNV Product Assurance AS后,第2家来自非欧盟国家的MDR公告机构,至此MDR公告机构增至40家。

截止目前,具有MDR审核资质的40家公告机构的地理分布如下:意大利有10家,德国有10家,荷兰有3家,芬兰有2家,波兰有2家,而西班牙、斯洛文尼亚、比利时、克罗地亚、法国、匈牙利、爱尔兰、挪威、捷克、斯洛伐克、塞浦路斯和瑞典、土耳其各有1家。

 截至目前为止,已获得MDR审核资质的40家公告机构清单如下: 

Body type Body Name Country
NB 0044 TÜV NORD CERT GmbH Germany
NB 0050 National Standards Authority of Ireland (NSAI) Ireland
NB 0051 IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A. Italy
NB 0123 TÜV SÜD Product Service GmbH Germany
NB 0124 DEKRA Certification GmbH Germany
NB 0197 TÜV Rheinland LGA Products GmbH Germany
NB 0297 DQS Medizinprodukte GmbH Germany
NB 0318 CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS Spain
NB 0344 DEKRA Certification B.V. Netherlands
NB 0373 ISTITUTO SUPERIORE DI SANITA’ Italy
NB 0425 ICIM S.P.A. Italy
NB 0426 ITALCERT SRL Italy
NB 0459 GMED SAS France
NB 0476 KIWA CERMET ITALIA S.P.A. Italy
NB 0477 Eurofins Product Testing Italy S.r.l. Italy
NB 0482 DNV MEDCERT GmbH Germany
NB 0483 MDC MEDICAL DEVICE CERTIFICATION GMBH Germany
NB 0494 SLG PRÜF UND ZERTIFIZIERUNGS GMBH Germany
NB 0537 Eurofins Electric & Electronics Finland Oy Finland
NB 0546 CERTIQUALITY S.r.l. Italy
NB 0598 ex:403 SGS FIMKO OY Finland
NB 0633 Berlin Cert Prüf- und Zertifizierstelle für Medizinprodukte GmbH Germany
NB 1023 INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390 Czech Republic
NB 1282 ENTE CERTIFICAZIONE MACCHINE SRL Italy
NB 1304 SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY – SIQ Slovenia
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 1912 Kiwa Dare B.V. Netherlands
NB 1936 TUV Rheinland Italia SRL Italy
NB 2265 3EC International a.s. Slovakia
NB 2274 TUV NORD Polska Sp. z o.o Poland
NB 2409 CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft. Hungary
NB 2460 DNV Product Assurance AS Norway
NB 2696 UDEM Adriatic d.o.o. Croatia
NB 2764 Notice Belgelendirme, Muayene ve Denetim Hizmetleri Anonim Şirketi Türkiye
NB 2797 BSI Group The Netherlands B.V. Netherlands
NB 2803 HTCert (Health Technology Certification Ltd) Cyprus
NB 2862 Intertek Medical Notified Body AB Sweden
NB 2975 SZUTEST Konformitätsbewertungsstelle GmbH Germany

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