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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