LiveZilla Live Chat Software

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.

 
LIBERTY MANAGEMENT GROUP LTD.
75 Executive Drive, Suite 114
Aurora, Illinois, USA - 60504
Phone : (630) 270-2921
Fax : (815) 986-2632
E-mail : info@libertymanagement.us