Directive 93 42 Eec Annex I pdfs

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B COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993...

B COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1) ... ...

http://www.emergogroup.com/sites/default/files/file/europe-consolidated-mdd-93-42-eec.pdf

Date added: April 2, 2015 - Views: 6

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Basic Information about the European Directive 93/...

Basic Information about the European Directive 93/42/EEC on Medical ... For clinical investigations the...

http://www.mdc-ce.de/fileadmin/user_upload/Downloads/mdc-Dokumente/Broschueren/040100_basic_info_93-42-EEC_06_e.pdf

Date added: December 4, 2013 - Views: 22

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Annex IX in the Medical Device Directive (93/42/...

DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 September 2007 ... set out in ...

http://ec.europa.eu/consumers/sectors/medical-devices/files/revision_docs/2007-47-en_en.pdf

Date added: September 28, 2012 - Views: 2

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DIRECTIVE 93/42/EEC - cemarking.in

DIRECTIVE 93/42/EEC . COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices . ... ...

http://cemarking.in/Directive%2093-42-EEC.pdf

Date added: July 29, 2016 - Views: 1

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EC Certificate Product Service - Sivantos

EC Certificate Full Quality ... Directive 93/42/EEC on Medical Devices (MDD), Annex II excluding (4) ......

https://media.sivantos.com/siemens-website/media/2014/05/EC_TUV-Certificate_2014_en.pdf

Date added: October 9, 2015 - Views: 1

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GUIDELINES ON MEDICAL DEVICES - European...

GUIDELINES ON MEDICAL DEVICES CLINICAL INVESTIGATIONS: ... 12 in line with Annex 7.2.3.5 of Directive...

http://ec.europa.eu/consumers/sectors/medical-devices/files/meddev/2_7_3_en.pdf

Date added: December 19, 2011 - Views: 26

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Product Service EC Certificate - corpuls

EC Certificate Full Quality ... Directive 93/42/EEC on Medical Devices ... inspection of the respective...

http://www.corpuls.com/fileadmin/pdf/Unternehmen/EN/131114_QM-System_GB_93-42-EWG-Annex-II.pdf

Date added: June 30, 2015 - Views: 1

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Medical device directive 93/42/EEC and the...

Medical device directive 93/42/EEC and the revision 2007/47/EC The changes (Amendment 2007/47/EC) to the...

http://www.quality-service.ch/pdf/Flyer_2007_47_EC_Vers01.pdf

Date added: February 29, 2012 - Views: 14

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CLASSIFICATION CRITERIA Definitions for the...

ANNEX IX CLASSIFICATION ... Definitions for the classification rules 1.1. Duration Transient ... For the...

http://www.lne-gmed.com/pdf/en/annex9-directive-93-42-amended.pdf

Date added: November 29, 2011 - Views: 19

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Amendments to the MDD 93/42/EEC - Crimson language

Amendments to the MDD 93/42/EEC . ... are also covered by the machinery directive need to meet the ER (...

http://www.crimsonlanguage.com/system/files/KEMAGuide_MDD_Revisions_0.pdf

Date added: April 4, 2015 - Views: 3

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NIST GCR 01-815 A Guide to the EU Medical Device ...

A Guide to the EU Medical Device Directive ... (EU) Medical Device Directive (MDD) 93/42/EEC]. It ......

http://gsi.nist.gov/global/docs/EUGuide_MedicalDvceDirective.pdf

Date added: February 28, 2012 - Views: 17

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EU Medical Device Directive (93/42/EEC) labelling...

EU Medical Device Directive (93/42/EEC ... The essential requirements of the Medical Device Directive (93...

http://www.sterilebarrier.org/media/59124/European-Union-Medical-Device-Directive-labelling-requirements.pdf

Date added: February 8, 2016 - Views: 4

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bsi. - ghorthodontics.com

Directive 93/42/EEC on Medical Devices, Annex II excluding Section 4 No. Issued To: ... For and on behalf...

https://www.ghorthodontics.com/PDF/QA/MDD-93_42-EEC.pdf

Date added: November 30, 2015 - Views: 1

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www.auditdata.com

Directive 93/42/EEC on Medical Devices (MDD), Annex Il ... For marketing of class Ill devices an...

https://www.auditdata.com/media/1390/ec_certificate_93-42-eec_mdd_annex_ii.pdf

Date added: February 8, 2016 - Views: 1

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MEDICAL DEVICES Guidance document Classification...

MEDICAL DEVICES: Guidance document - Classification of ... performances referred to in sections 1 and 3...

http://economie.fgov.be/nl/binaries/02-classificatiegids_COM_2_4_1_rev_9_classification_en_tcm325-45934.pdf

Date added: May 1, 2016 - Views: 1

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Appendix II of the directive 93-42 EEC - Erbe Med

according the directive 91/471 Annex Il ... applies a quality assurance system for the medical devices...

http://www.erbe-med.com/pdf/EC_93-42-EEC_EN.pdf

Date added: October 9, 2015 - Views: 1

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www.p3-medical.com

Directive 93/42/EEC on medical devices, Annex V ... Annex V Restricted to the aspects of manufacture...

http://www.p3-medical.com/pdf/Directive%2093%2042%20EEC%20Annex%20V.pdf

Date added: March 16, 2014 - Views: 1

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www.weinmann-emergency.com

Directive 93/42/EEC Annex Il, excluding Section 4 ... excluding section 4 of thedirective 93/42/EEC have...

https://www.weinmann-emergency.com/downloads/quality/EC_directive_93_42_EEC_annex_II_EN.pdf

Date added: May 1, 2016 - Views: 1

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Contents of Technical Documentation for MDD 93/42/...

Contents of Technical Documentation for MDD 93/42/EEC and IVDD 98/79/EC 140017/00 Page 1 of 3 © mdc...

https://www.mdc-ce.de/fileadmin/user_upload/Downloads/mdc-Dokumente/Formulare_Recommend/140017_00_e_Contents_of_Technical_Documentation_MDD_93-42-EEC_IVDD_98-79-EC.pdf

Date added: June 18, 2016 - Views: 1

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cdn.atmosmed.com

according the directive 93/42/EECJ Annex V As a notified body of the European Union, DEKRA...

http://cdn.atmosmed.com/docs/14975/e_v_dir_93_42_eec_3.pdf

Date added: September 24, 2014 - Views: 1

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GUIDELINES ON MEDICAL DEVICES CLINICAL...

90/385/EEC and to Annex X of Directive 93/42/EEC: “All serious adverse events must be fully recorded and...

http://ec.europa.eu/DocsRoom/documents/16477/attachments/1/translations/en/renditions/native

Date added: July 29, 2016 - Views: 1

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Directive 90/385/EEC on active implantable medical...

M1 Council Directive 93/42/EEC of 14 June 1993 L 169 1 12.7.1993 M2 Council Directive 93/68/EEC of 22...

http://www.emergogroup.com/sites/default/files/file/europe-consolidated-90-385-eec.pdf

Date added: March 20, 2015 - Views: 12

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EN - Choose your language

EN EN EUROPEAN COMMISSION Brussels, 27.8.2010 COM ... of Directive 93/42/EEC 5 Annex I section 13(6)(h)...

http://ec.europa.eu/consumers/sectors/medical-devices/files/pdfdocs/reprocessing_report_en.pdf

Date added: January 1, 2012 - Views: 4

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MEDICAL DEVICES : Guidance document

MEDICAL DEVICES : Guidance document ... Directive 93/42/EEC, ... Annex V, section 3.2 of Directive 93/42/...

http://ec.europa.eu/consumers/sectors/medical-devices/files/meddev/2_1-1___04-1994_en.pdf

Date added: January 25, 2012 - Views: 3

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www.pall.com

Directive 93/42/EEC and the Medical Devices Regulations 2002 ... has been assessed against the...

http://www.pall.com/pdfs/About-Pall/Switz_Med_Dev_Dir_9342EEC.pdf

Date added: May 1, 2014 - Views: 1

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cdn.atmosmed.com

according the directive 93/42/EEC Annex Il excluding section (4) As a notified body of the European...

http://cdn.atmosmed.com/docs/14974/e_ii_dir_93_42_eec_4.pdf

Date added: December 28, 2014 - Views: 1

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static.plenummedia.com

EC Directive 93/42/EEC Annex VI, ... The requirements of Annex VI, Article 3 of the directive have been...

http://static.plenummedia.com/30324/files/20090910140714-ec_directive_93_42_ecc.pdf

Date added: April 18, 2014 - Views: 1

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Annex II of Directive 93 42 EEC - Mesa Med

DQS Medizinprodukte GmbH is a Notified Body according to CouncilDirective 93/42/EEC ... Annex II –...

http://www.mesamed.de/mesa-ftp/pdf/eng/zertifikat_annex_2_of_directive_93_42_eec_eng.pdf

Date added: March 5, 2015 - Views: 1

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Med-Info Council Directive International expert...

Council Directive 93/42/EEC on Medical Devices Diagnosis, prevention, monitoring, ... Annex IX of the ...

http://www.tuv-sud.co.uk/uploads/images/1384776337983527690051/revision-of-mdd-93-42-eec.pdf

Date added: October 4, 2015 - Views: 1

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certificate_EC Directive 93/42/EEC -...

Directive 93/42/EEC Annex Il, excluding Section 4 ... excluding section 4 of thedirective 93/42/EEC have...

http://www.rapidbiomed.com/wp-content/uploads/2016/04/E_93_42_EEC.pdf

Date added: June 18, 2016 - Views: 1

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INFORMATION ON TERUMO MEDICAL DEVICES AND...

April 2012 1/2 INFORMATION ON TERUMO MEDICAL DEVICES AND PHTHALATES (DEHP, DBP, BBP) Phthalates of...

http://www.terumo-europe.com/SiteCollectionDocuments/About%20Terumo/medical-devices-containing-phthalates.pdf

Date added: July 31, 2015 - Views: 1

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NBOG’s Best Practice Guide AIMDD, 2010-3

NBOG’s Best Practice Guide applicable for AIMDD, MDD, ... Directive 93/42/EEC on Medical Devices, Annex...

http://www.nbog.eu/resources/NBOG_BPG_2010_3.pdf

Date added: December 6, 2011 - Views: 36

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www.velfina.com

EC Directive 93/42/EEC Annex Il, Article 3 Full Quality Assurance System Medical Devices ... EC Directive...

http://www.velfina.com/upload/certificates/Directive_93_42_EEC_Annex_II.pdf

Date added: September 24, 2014 - Views: 1

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GUIDELINES ON MEDICAL DEVICES - MedDev INFO

GUIDELINES ON MEDICAL DEVICES ... Annex 7 of directive 90/385/EEC and section 2.1 of Annex X of directive...

http://www.meddev.info/_documents/2_7_4_en.pdf

Date added: March 6, 2013 - Views: 1

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Directive 93 42 EEC - polydentia.ch

Directive 93/42/EEC on medical devices, Annex Il ... Certificate according to Annex Il ... Directive 93_...

http://www.polydentia.ch/uploads/tx_iplpdprodotti/Directive_93_42_EEC_01.pdf

Date added: July 29, 2016 - Views: 1

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QS Certificate Quality Assurance System Directive ...

Directive 93/42/EEC, Annex Il for the design, ... QS Certificate Quality Assurance System Directive 93/42...

http://eco-analytika.com/d/169064/d/directive_93_94_eec_ii_english.pdf

Date added: March 16, 2014 - Views: 14

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Medical Device Directive 93/42/EEC CE-Marking What...

Directive 93/42/EEC Harmonized European Standards, available for a fee. They areconsidered the ‘state of...

http://www.ce-mark.com/medical%20devices%20know%20and%20do.pdf

Date added: December 23, 2015 - Views: 3

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CE Marking and Conformity Assessment Procedures...

CE Marking and Conformity Assessment Procedures for Medical Devices Medical Devices 93/42/EEC ... to ...

https://www.tuv-nord.com/cps/rde/xbcr/SID-96592261-6973CCA1/tng_en/information-ce-symbol.pdf

Date added: March 30, 2016 - Views: 1

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Conformity Assessment 3.9 A 4 Declaration of...

Declaration of Conformity In Annex II, ... • the EC directive(s) ... Reference 93/42/EEC article 11 and ...

https://www.mdc-ce.de/fileadmin/user_upload/Downloads/Leitlinien/EK-Med/EK-Med_309_1107_A04_EN_Declaration_of_Conformity.pdf

Date added: September 9, 2015 - Views: 1

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411 08e Checklist MDD Annex I - dqs-med.de

411_08e_Checklist_MDD_Annex_I.docx Version: 1.0 1 /12 ... according to the medical device directive 93/42...

http://www.dqs-med.de/fileadmin/wissen/pdf/zertifizierungsdokumente/411_08e_Checklist_MDD_Annex_I.pdf

Date added: August 10, 2015 - Views: 1

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www.p3-medical.com

Directive 93/42/EEC on medical devices, Annex Il (excluding section 4) Issue 21 Detailed scope Sterile...

http://www.p3-medical.com/pdf/Directive%2093%2042%20EEC%20Annex%20II.pdf

Date added: February 17, 2014 - Views: 3

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Directive 93/42/EEC - Ultra-Controlo

Directive 93/42/EEC on medicai devices, Annex II (excluding Section 4) For the followmg products ......

http://ultracontrolo.com/certificados/CERTIFICADO_93_42.pdf

Date added: July 29, 2016 - Views: 1

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ANNEX II Directive 93/42/EEC (without section 4)

˚ fi ˛ ˝ ˙ ˆ ˙ ˚ ˇ ˘ ˚ ˚ ˝ ˘ ˝ ˚ ˙˝ ˚˛ ˇ ANNEX II Directive 93/42/EEC (without section 4) This Appendix...

http://stemcup.com/v/pdf/EC_Certificate_Annex_II_3.pdf

Date added: July 29, 2016 - Views: 1

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INTERPRETATIVE DOCUMENT of the Commission’s...

93/42/EEC / Annex 1 of Directive 90/385/EEC or is more specific than the essential requirements of the...

http://ec.europa.eu/DocsRoom/documents/10261/attachments/1/translations/en/renditions/native

Date added: July 29, 2016 - Views: 1

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sterimedix.com

Directive 93/42/EEC on medical devices, Annex Il (excluding Section 4) ... Certificate according to Annex...

http://sterimedix.com/pdf/Directive%2093-42-EEC.pdf

Date added: October 9, 2015 - Views: 1

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KMBT C654-20151210115438 - Memmert

Directive 93/42/EEC Annex Il, excluding Section 4 ... excluding section 4 of thedirective 93/42/EEC have...

https://www.memmert.com/fileadmin/products/documents/quality_certificates/EU_MDD-93-42_2020_en.pdf

Date added: February 8, 2016 - Views: 1

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EC Certificate - Allied Healthcare Products, Inc.

EC Certificate FULL QUALITY ASSURANCE SYSTEM Directive 93/42/EEC on IVledical Devices, Annex II (3) ......

http://www.alliedhpi.com/images/AHPI_CE.pdf

Date added: July 8, 2014 - Views: 1

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U:QUALITYZertifikate u Konformitaetserklaerungen...

,0 ~ EC Certificate Product Service Full Quality Assurance System Directive 93/42/EEC on Medical Devices...

http://www.corpuls.com/fileadmin/pdf/Unternehmen/EN/QM-System_GB_93-42-EWG-Annex-II.pdf

Date added: October 21, 2013 - Views: 1

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MEDICAL DEVICES : Guidance document

MEDICAL DEVICES : Guidance document ... THE COUNCIL DIRECTIVE 93/42/EEC ON MEDICAL DEVICES ... Background...

http://www.emergogroup.com/sites/default/files/file/europe-medev-2_1-5.pdf

Date added: May 5, 2016 - Views: 2