Directive 93 42 Eec Annex I pdfs

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B COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 - Emergo

B COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1) ... Directive 89/391/EEC of 12 June 1989 on the introduction of

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

Date added: August 21, 2016 - Views: 1

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Basic Information about the European Directive 93/42/EEC on ...

MDD: THE MEDICAL DEVICES DIRECTIVE 93/42/EEC INCLUDING DIRECTIVE 2007/47/EC.....6 MEDICAL DEVICE ... labeling as outlined in Annex I of the MDD.

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

Date added: August 19, 2016 - Views: 3

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

DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 September 2007 ... set out in Annex VIII to Directive 93/42/EEC, and (iii)

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

Date added: August 21, 2016 - Views: 1

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GUIDELINES ON MEDICAL DEVICES - European Commission

GUIDELINES ON MEDICAL DEVICES CLINICAL INVESTIGATIONS: ... 12 in line with Annex 7.2.3.5 of Directive 90/385/EEC and Annex X.2.3.5 of Directive 93/42/EEC .

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

Date added: August 18, 2016 - Views: 3

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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/EEC Annex II Ref: Device: Date:

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

Date added: August 19, 2016 - Views: 8

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MEDICAL DEVICES Guidance document Classification of ... - Statbel

MEDICAL DEVICES: Guidance document - Classification of ... performances referred to in sections 1 and 3 of Annex I of Directive 93/42/EEC under the normal conditions ...

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

Date added: August 21, 2016 - Views: 1

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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 the art’, and ... Annex II (minus point 4) ...

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

Date added: August 24, 2016 - Views: 2

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Annex 9 directive 93/42/EEC amended ... - LNE / G-MED

ANNEX IX CLASSIFICATION ... Definitions for the classification rules 1.1. Duration Transient ... For the purposes of this Directive devices other than those referred ...

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

Date added: August 21, 2016 - Views: 3

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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 (Annex I) ... 93/42/EEC, respectively, which ...

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

Date added: August 21, 2016 - Views: 3

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Directive 90/385/EEC on active implantable ... - Emergo

This document is meant purely as a documentation tool and the institutions ... Directive 93/42/EEC of 14 June 1993 L 169 1 12.7.1993 M2 Council Directive 93/68/EEC ...

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

Date added: August 19, 2016 - Views: 12

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Med-Info MDD revised – a survey of the essential modifications

a survey of the essential modifications ... the Medical Devices Directive 93/42/EEC (MDD) and the ... Annex II, 3.2b, ...

http://www.tuv-sud.com/uploads/images/1378298411363048000564/revision-of-mdd-93-42-eec.pdf

Date added: August 21, 2016 - Views: 3

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ANNEX II.3 Directive 93/42/EEC - Borer Chemie

ANNEX II.3 Directive 93/42/EEC This approval is based on the result of the audit documented in the report dated April 7, 2010. The scope of validity covers the products

http://www.borer.ch/uploads/media/RL_93-42-EWG_CE_1250_en_01.pdf

Date added: August 29, 2016 - Views: 1

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By Royal Charter EC Certificate -Production Quality Assurance

bsi. By Royal Charter EC ... Directive 93/42/EEC on ... on the basis of our examination of the quality assurance system under the requirements of Council Directive 93 ...

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

Date added: August 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 is valid only in connection

http://www.stemcup.ch/v/pdf/EC_Certificate_Annex_II_3.pdf

Date added: August 29, 2016 - Views: 1

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

Contents of Technical Documentation for MDD 93/42/EEC and IVDD 98/79/EC 140017/00 Page 1 of 3 © mdc 2016-02-04 ... according to Annex IX of Directive 93/42/EEC

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: August 29, 2016 - 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_42_EEC.pdf

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

Date added: August 21, 2016 - Views: 1

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Annex II of Directive 93 42 EEC - Mesa Med

DQS Medizinprodukte GmbH is a Notified Body according to Council Directive 93/42/EEC ... Annex II – excluding Section 4 of Council Directive 93/42/EEC

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

Date added: August 29, 2016 - Views: 1

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Product Service EC Certificate - corpuls

EC Certificate Full Quality ... Directive 93/42/EEC on Medical Devices ... inspection of the respective devices I device categories in accordance with MDD Annex 11.

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

Date added: August 28, 2016 - 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 concerns to securing and maintaining sterility conditions.

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

Date added: September 30, 2016 - Views: 1

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

EU Medical Device Directive (93/42/EEC ... The essential requirements of the Medical Device Directive (93/42/EEC) ... for labelling of medical devices in Annex 1 ...

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

Date added: August 18, 2016 - Views: 4

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Med-Info Council Directive International expert information ...

contained in Directive 93/42/EEC incl. 2007/47/EC What exactly is a Medical Device? ... Annex IX of the Directive stipulates the classification

https://www.tuv-sud.com/uploads/images/1441713496633121630881/council-directives-9394eec.pdf

Date added: November 13, 2016 - Views: 1

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www.pall.com

Directive 93/42/EEC and the Medical Devices Regulations 2002 ... has been assessed against the requirements of Annex Il of the Medical Devices Directive 93/42/EEC, ...

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

Date added: August 21, 2016 - Views: 1

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

A Guide to the EU Medical Device Directive ... (EU) Medical Device Directive (MDD) 93/42/EEC]. It ... following Annexes of the Directive: Annex II EC Declaration of ...

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

Date added: August 21, 2016 - Views: 1

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e ii dir 93 42 eec - ATMOS Med

according the directive 93/42/ËEC, Annex Il ... applies a quality assurance system for the medical devices listed in the annex according to the directive 93/42/EEC ...

http://cdn.atmosmed.com/docs/14974/e_ii_dir_93_42_eec_2.pdf

Date added: March 5, 2017 - Views: 1

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www.weinmann-emergency.com

Directive 93/42/EEC Annex Il, excluding Section 4 ... excluding section 4 of the directive 93/42/EEC have been met for the listed products.

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

Date added: August 29, 2016 - Views: 1

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GUIDELINES ON MEDICAL DEVICES

23 Annex X of Directive 93/42/EEC and Annex 7 of Directive 90/385/EEC, respectively. 24

https://www.globalcomplianceseminar.com/wp-content/uploads/2016/03/MEDDEV-2.12-2-Rev-2-POST-MARKET-CLINICAL-FOLLOW-UP-STUDIES.pdf

Date added: August 21, 2016 - 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 insufflator tubing, ... according to Annex Il ...

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

Date added: August 21, 2016 - Views: 1

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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 ... Certificate according to Annex II (Section 4) is required.

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

Date added: August 29, 2016 - Views: 8

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93/42/EEC - incenter.medical.philips.com

Council Directive: 93/42/EEC ... The product is Class IIa according to Annex IX of Directive 93/42/EEC. Global Medical Device Nomenclature Code (GMDN) is 37257.

http://incenter.medical.philips.com/doclib/getDoc.aspx?func=ll&objId=579638&objAction=Open

Date added: January 26, 2017 - Views: 1

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LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical ...

LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices Page 1 Name and address of the notified bodies Identification ... Annex II Annex IV Annex V

http://emisoft.co.uk/standards/europe/93-42-md/nb.pdf

Date added: August 30, 2016 - Views: 1

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Experience with Directive 93/42/EEC (MDD) - ffm-luebeck.com

Experience with Directive 93/42/EEC Preliminary Remarks Scope of this presentation is based on the Dräger product portfolio: • Anaesthesiology

https://www.ffm-luebeck.com/fileadmin/website/Presse/RegulatoryAffairs2012/3-LectureExperience_with_Directive_Gebhardt.pdf

Date added: August 29, 2016 - Views: 1

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Rules for Conformity Assessment of Medical Devices according ...

Rules for Conformity Assessment of Medical Devices according to Directive 93/42/EEC ... (Annex V Directive ...

http://www.rina.org/en/Lists/PageAttachments/Rules_certification_ISO_13485.pdf

Date added: August 21, 2016 - Views: 1