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

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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) ... 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/...

Basic Information about the European Directive 93/42/EEC on Medical ... For clinical investigations the rules laid down in Article 15 and Annex X of the MDD apply ...

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

Date added: August 18, 2016 - Views: 1

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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 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...

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: 1

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CLASSIFICATION CRITERIA Definitions for the...

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: 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/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: 5

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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: 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 ... Directive include: Clinical data (Annex X) ...

http://www.quality-service.ch/pdf/Medical%20Device%20Directive%2093.pdf

Date added: August 29, 2016 - Views: 1

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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 (93/42/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: 3

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

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: 4

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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: 1

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

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: 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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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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EC Certificate Product Service - Sivantos

EC Certificate Full Quality ... Directive 93/42/EEC on Medical Devices (MDD), Annex II excluding (4) ... • Directive for Active lmplantable Medical Devices 9013851EEC

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

Date added: August 29, 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 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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EC -Directive 93/ 42/EEC Annex II, Article 3...

EC -Directive 93/ 42/EEC Annex II, ... [Full Quality Assurance System Medical Devices] Certificate for a Quality Management System ... 42 #3 #42 ...

http://unimed-m.ru/upload/file/R-RUI%20E-Catalogue.pdf

Date added: September 30, 2016 - Views: 1

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By Royal Charter EC Certificate -Production...

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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INFORMATION ON TERUMO MEDICAL DEVICES AND...

April 2012 1/2 INFORMATION ON TERUMO MEDICAL DEVICES AND PHTHALATES (DEHP, DBP, BBP) Phthalates of Concerns and the Medical Device Directive 93/42/EEC

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

Date added: August 19, 2016 - Views: 1

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Med-Info Council Directive International expert...

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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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.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 ...

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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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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CE Marking and Conformity Assessment Procedures...

CE Marking and Conformity Assessment Procedures for Medical Devices Medical Devices 93/42/EEC ... to Directive 93/42/EEC Annex II, Section 4,

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

Date added: August 19, 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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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 - 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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LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/...

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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MDD 93/42/EEC - vapormed.com

Directive 93/42/EEC on Medical Devices (MDD), Annex Il ... For marketing of class Ill devices an additional Annex Il (4) certificate is mandatory. See also notes ...

http://www.vapormed.com/media/pdf/EC-Certificate_93-42EEC.pdf

Date added: August 29, 2016 - 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 III (Devices in Class IIb and III)

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

Date added: August 18, 2016 - Views: 2

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European Medical Device Directive - Essential...

European Medical Device Directive – Essential Requirements Checklist ... Essential Requirements – Annex I, 93/42/EEC as compliance . amended by Directive 2007/47/EC .

https://www.tga.gov.au/sites/default/files/devices-forms-ecmra-ep-checklist.pdf

Date added: August 30, 2016 - Views: 1

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Rules for Conformity Assessment of Medical Devices...

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

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EN - TSAPPS at NIST

EN EN EUROPEAN COMMISSION Brussels, XXX […](2011) COMMISSION ... Annex 1 to Directive 90/385/EEC and Annex I to Directive 93/42/EEC, respectively, ...

https://tsapps.nist.gov/notifyus/docs/wto_country/EEC/full_text/pdf/EEC405(english).pdf

Date added: September 27, 2016 - Views: 1

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Directive 93/42/EEC on Medical Devices, Annex II...

Directive 93/42/EEC on Medical Devices, Annex II (4) ... This certificate is valid only together with EC Certificate according to Directive . 93/42/EEC . on .

http://sanatmetal.com/content/_common/attachments/5-701-204-1111_emki_1343.pdf

Date added: November 13, 2016 - 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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According to MDD - TÜV Rheinland

According to MDD Annex IX [93/42/EEC] Rule 1 All non-invasive devices are in Class I , unless one of the rules set out hereinafter applies. Rule 2

http://www.tuv.com/media/india/medicaldevices_1/According_to_MDD_Annex_IX_93_42EEC.pdf

Date added: October 3, 2016 - 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 met. ... EC Directive, and can be used by ...

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

Date added: August 29, 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: 6

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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 Union, DEKRA Certification _GrnbH çertifie$,fthat C;

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

Date added: August 29, 2016 - Views: 1

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Essential Requirements according to MDD 93/42/EEC;...

Essential Requirements according to MDD 93/42/EEC; Annex I; ... tion, of category 1 or 2, in accordance with Annex I to Directive 67/548/EEC, these devices must be

https://www.medentika.de/fileadmin/user_upload/Medentika/Download/Essential_Requirements.pdf

Date added: September 16, 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 CertificatjonGrnbHcertifieSih th ... directive 93/42/EEC annex V.

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

Date added: August 29, 2016 - 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 Directive stipulates the classification

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

Date added: August 21, 2016 - Views: 1

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CE Marking – Changing & Evolving Requirements

Directive 93/42/EEC . Copyright © 2013 BSI. All rights reserved. 4 New Regulations – 2015? ... human beings, which are listed in Annex XV shall be considered

http://www.bsigroup.com/meddev/LocalFiles/en-US/Roadshow%20Resources%202013/02%20CE%20Marking-%20Changing%20Requirements%20-%20September%202013.pdf

Date added: August 21, 2016 - Views: 1

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www.velfina.com

EC Directive 93/42/EEC Annex Il, Article 3 Full Quality Assurance System Medical Devices ... EC Directive, and can be used by the company Cologne, 27.10.2009

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

Date added: August 29, 2016 - Views: 1

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

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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Class 1, Rule 1, per Annex IX of Directive 93/42/...

... per Annex IX of Directive 93/42/EEC Global Medical ... Council Directive 93/42/EEC concerning medical devices as amended ... Medical Device Directive 93/42/EEC.

http://incenter.medical.philips.com/doclib/getDoc.aspx?func=ll&objId=6583776&objAction=Open

Date added: August 30, 2016 - Views: 3

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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/ECC, Annex II Author: Memmert GmbH +Co. KG Created Date:

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

Date added: August 30, 2016 - Views: 1

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Directive 93/42/EEC - ultracontrolo.com

Directive 93/42/EEC on medicai devices, Annex II (excluding Section 4) Forthefollowing proflucts ... Certificate according to Annex II (Section 4} is required.

http://www.ultracontrolo.com/certificados/93_42_EEC.pdf

Date added: August 29, 2016 - Views: 1