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) ... 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/...

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

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: 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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DIRECTIVE 93/42/EEC - cemarking.in

DIRECTIVE 93/42/EEC . COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices . ... Directive 76/764/EEC of 27 July 1976 on the approximation of the ...

http://cemarking.in/Directive%2093-42-EEC.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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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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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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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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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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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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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) of Directive 93/42/EEC 6 OJ L 247, 21.9.2007, p. 21

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

Date added: August 21, 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 listed in the annex according to the directive 93/42/EEC ...

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

Date added: August 29, 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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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: 2

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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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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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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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MEDICAL DEVICES Guidance document Classification...

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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bsi. - ghorthodontics.com

Directive 93/42/EEC on Medical Devices, Annex II excluding Section 4 No. Issued To: ... For and on behalf of BSI, a Notified Body for the above Directive ...

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

https://www.auditdata.com/media/1390/ec_certificate_93-42-eec_mdd_annex_ii.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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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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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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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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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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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: 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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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 applicable Medical Devices Directive, ...

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

Date added: August 29, 2016 - Views: 1

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COMMISSION DIRECTIVE 2003/12/EC on the...

on the reclassification of breast implants in the framework of Directive 93/42/EEC concerning medical devices ... point 4 of Annex II to Directive 93/42/EEC.

http://www.lne-gmed.com/pdf/en/directive_2003_12.pdf

Date added: August 28, 2016 - Views: 1

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GBUK Directive 93 42 EC Annex II SGS 87416 - GBUK...

Directive 93/42/EEC on medical devices, Annex Il (excluding Section 4) For the following products ... Certificate according to Annex Il (Section 4) is required.

http://www.gbukhealthcare.com/wp-content/uploads/pdf/GBUK-Directive-93-42-EC-Annex-II-SGS87416.pdf

Date added: August 29, 2016 - Views: 1

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EC Certificate - DENTSPLY Implants

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

http://www.dentsplyimplants.com/~/media/M3%20Media/DENTSPLY%20IMPLANTS/1215030%20TUV%20EC%20Certificate%20Directive%209342EEC%20Annex%20II%20Dentsply%20Implants%20Manufacturing%20GmbH.ashx?filetype=.pdf

Date added: August 29, 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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MEDICAL DEVICES : Guidance document

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

http://ec.europa.eu/consumers/sectors/medical-devices/files/meddev/2_1_5____06-1998_en.pdf

Date added: August 21, 2016 - Views: 1

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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/EEC)

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

applies a quality assurance system for the medical devices listed in the annex according to the directive 93/42/EEC annex ll. The approval is based on the result

http://www.erbe-med.com/pdf/Appendix_II_to_the_directive_93-42-EEC_excluding_section_4.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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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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DQS GmbH - osmed

DQS GmbH Deutsche ... Annex II of Directive 93/42/EEC with respect to the following medical devices: ... As set out in section 5, Annex II, of the said directive,

http://www.osmed.biz/pdf/2009_10-Annex-II-93-42-EEC.pdf

Date added: August 29, 2016 - Views: 1

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www.velfina.ro

EC Directive 93/42/EEC; Annex Il without Article 4 ... The requirements of Annex Il (without Article 4) of the directive have been ... aforementioned EC Directive, ...

http://www.velfina.ro/certificari/Directive%2093_42_EEC,%20Annex%20II.pdf

Date added: August 29, 2016 - 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 immediately notified to all competent authorities of

http://ec.europa.eu/DocsRoom/documents/10330/attachments/1/translations/en/renditions/native

Date added: August 19, 2016 - Views: 1

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www.otopront.de

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.

http://www.otopront.de/fileadmin/pdf/zertifikate/English/MDD_93-42-EEC_-_english.pdf

Date added: August 29, 2016 - Views: 1

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KMBT C654-20151210115438 - Memmert

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.memmert.com/fileadmin/products/documents/quality_certificates/EU_MDD-93-42_2020_en.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: 1

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sterimedix.com

Directive 93/42/EEC on medical devices, Annex Il (excluding Section 4) ... Certificate according to Annex Il (Section 4) is required. Page 2 of 2 . Created Date:

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

Date added: August 21, 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

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EC Certificate TlfVRheinland - CeramOptec

EC Certificate TlfVRheinland Directive 93/42/EEC ... excluding section 4 of the directive 93/42/EEC have been met for the ... defined by Annex II,

http://www.ceramoptec.de/fileadmin/user_upload/pdf/Zertifikate/CO_CERT_93-42-EEC-E_2015-06-22.pdf

Date added: August 29, 2016 - Views: 1