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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) ... accordance with Annex I to Directive 67/548/EEC, ...

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

Date added: April 2, 2015 - Views: 4

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Basic Information about the European Directive 93/...

Basic Information about the European Directive 93/42/EEC on Medical Devices . ... VII of the Medical Devices Directive 93/42/EEC (MDD) Annex II ...

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: 19

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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 amending Council Directive 90/385/EEC on the approximation of the laws of the ...

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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CLASSIFICATION CRITERIA Definitions for the...

Definitions for the classification rules 1.1. ... For the purposes of this Directive devices other than those referred to ... Annex 9 directive 93/42/EEC amended, ...

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

Date added: November 29, 2011 - Views: 18

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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: December 19, 2011 - Views: 24

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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: March 16, 2014 - Views: 1

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Annex II of Directive 93 42 EEC - MESA Med

Annex to Certificate Certificate registration No.: 304486 MR2 Certificate unique ID: 170602814 Effective date: 2014-12-11 MESA Medizintechnik GmbH

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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www.weinmann-emergency.com

EC Certificate Directive 93/42/EEC Annex Il, excluding Section 4 Full Quality Assurance System Medical Devices TÜVRheinland Manufacturer: Products:

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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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 93/42/EEC in an adequate human clinical environment.

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

Date added: March 6, 2013 - Views: 1

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MEDICAL DEVICES Guidance document Classification...

This MEDDEV contains guidance for the application of the classification rules for medical devices as set out in Annex IX of Directive 93/42/EEC1, as amended. It

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

Amendments to the MDD 93/42/EEC . ... (Annex I) of the Machinery directive to the extent to which they are ... paragraph in the Articles 3 of Directive 93/42/EEC, ...

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

Date added: April 4, 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 ... Directive include: Clinical data (Annex X) ...

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

Date added: July 17, 2013 - Views: 2

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cdn.atmosmed.com

DEK OEKRA EKAA EC CERTIFICATE for the Quality Assurance System 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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static.plenummedia.com

APPROVAL EC Directive 93/42/EEC Annex VI, Article 3 Quality Assurance System Product Medical Devices TÜVRheinland Manufacturer: Scope: Date of Expiry:

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 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: October 9, 2015 - Views: 1

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Product Service EC Certificate - corpuls

EC Certificate Full Quality Assurance System Directive 93/42/EEC on Medical Devices (MDD), Annex 11 excluding (4) (Devices in Class lIa, IIb or 111)

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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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: December 28, 2014 - 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: December 23, 2015 - Views: 1

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EC -Directive 93/ 42/EEC Annex II, Article 3...

EC -Directive 93/ 42/EEC Annex II, Article 3 Certificate for EN ISO 13485: 2003 [Full Quality Assurance System Medical Devices] Certificate for a Quality Management ...

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

Date added: January 4, 2014 - Views: 1

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www.p3-medical.com

SGS EC Certificate Full Quality Assurance System: GB96/7424, continued P3 Medical Limited Directive 93/42/EEC on medical devices, Annex Il (excluding section 4)

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

Date added: February 17, 2014 - Views: 3

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www.pall.com

Statutory Instrument 2002 No. 618 ... has been assessed against the requirements of Annex Il of the Medical Devices Directive 93/42 ... Directive 93/42/EEC and 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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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 Annex II, ...

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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Appendix II of the directive 93-42 EEC -...

DE EC CERTIFICATE for the Quality Assurance System according the directive 91/471 Annex Il excluding seß As a notified body of the European Union, DE5RÁ r i 1

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

Date added: October 9, 2015 - Views: 1

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www.velfina.com

Manufacturer: Scope: Date of Expiry: APPROVAL EC Directive 93/42/EEC Annex Il, Article 3 Full Quality Assurance System Medical Devices TÜVRheinland

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

Date added: September 24, 2014 - Views: 1

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bsi. - G&H Orthodontics

bsi. By Royal Charter EC Certificate -Full Quality Assurance System Directive 93/42/EEC on Medical Devices, Annex II excluding Section 4 No. Issued To:

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

Date added: November 30, 2015 - Views: 1

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

SQS as a conformity assessment body identification number 1250 herewith certifies the company Borer Chemie AG CH-4528 Zuchwil the use of a quality assurance system in ...

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

Date added: September 24, 2014 - Views: 1

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Content of mandatory certificates - MedDev INFO

Content of mandatory certificates Chapter: 2.5.1 Conformity assessment procedures; General rules ... (Annex V of the Directive 93/42/EEC on Medical Devices)

http://www.meddev.info/_documents/R2_5_1-4_rev4.pdf

Date added: December 6, 2011 - Views: 21

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EC Certificate - DENTSPLY Implants

EC Certificate Full Quality Assurance System Directive 93/42/EEC on Medical Devices (MDD), Annex II excluding (4) (Devices in Class lla, llb or III)

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 13, 2013 - Views: 2

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ritter-online.de

TÜVRheinland EC Certificate Directive 93/42/EEC Annex Il, excluding Section 4 Full Quality Assurance System Medical Devices Manufacturer: Products:

http://ritter-online.de/pdf/iso/Directive_93-42-EEC_Annex_II.pdf

Date added: July 31, 2015 - 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: February 8, 2016 - Views: 1

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NBOG’s Best Practice Guide AIMDD, 2010-3

NBOG’s Best Practice Guide 2010-3 NBOG BPG 2010-3 Page 2 of 35 Module B = EC type-examination. ... Directive 93/42/EEC on Medical devices, Annex II excluding (4)

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

Date added: December 6, 2011 - Views: 34

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93.42.EEC & 90.385.EEC New Regulation - Xavier...

Directive 93/42/EEC . Copyright © 2012 BSI. All rights reserved. 4 New Regulation ... For devices listed in Annex XV for which the manufacturer does not claim

http://xavierhealth.org/wp-content/uploads/Halliday_How-to-Get-a-Product-into-the-European-Market.pdf

Date added: November 26, 2013 - Views: 1

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Guidance on Design-Dossier Examination and Report...

Guidance on Design-Dossier Examination and ... – the Medical Devices Directive 93/42/EEC section 4 of Annex II and section 4 ... 93/42/EEC Annex III and 98/79/EC ...

http://www.nbog.eu/resources/NBOG_BPG_2009_1.pdf

Date added: December 31, 2011 - Views: 34

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411 08e Checklist MDD Annex I - DQS...

411.08 Checklist for evaluation of the essential requirements 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 10, 2015 - 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: November 20, 2012 - Views: 2

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

... Medical Device Directive (MDD) 93/42/EEC]. It ... demonstrate conformity of the product to the Medical Device Directive: Annex II, Annex VII and Annex IV,

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

Date added: February 28, 2012 - Views: 17

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EC Certificate - DENTSPLY Implants

Illiò SUD Product Service EC Certificate EC Design-Examination Certificate Directive 93/42/EEC on Medical Devices (MDI)), Annex Il (4) (Devices in Class Ill)

http://www.dentsplyimplants.com/~/media/M3%20Media/DENTSPLY%20IMPLANTS/1214423%20Certificate%20DENTSPLY%20IM%20EC%20Design%20Examination.ashx?filetype=.pdf

Date added: June 25, 2013 - Views: 3

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www.auditdata.com

O o EC Certificate Full Quality Assurance System Directive 93/42/EEC on Medical Devices (MDD), Annex Il excluding (4) (Devices in Class lla, 11b or Ill)

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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217-pdf 01Council Directive 93-42-EEC Index -...

217 Rev 01 Council Directive 93/42/EEC Index Page 2 of 69 Indent Parag Annex Article Term Line L 5 1 1active implantable devices 512 1A I, 1.3. IX active medical ...

http://www.quality-works.com/download/council-directive-93-42-eec-index-preview.pdf

Date added: May 15, 2012 - Views: 4

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www.terumomedical.com

EC Certificate Directive 93/42/EEC Annex Il, excluding Section 4 Full Quality Assurance System Medical Devices TÜVRheinland Manufacturer: Products:

http://www.terumomedical.com/aboutus/93-42-EEC-color(nocover).pdf

Date added: January 8, 2013 - Views: 3

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KMBT C654-20151210115438 - Memmert

EC Certificate Directive 93/42/EEC Annex Il, excluding Section 4 Full Quality Assurance System Medical Devices TÜVRheinland Manufacturer: Products.

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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Understanding the Machinery Directive (2006/42/EC)

Understanding the Machinery Directive ... the Medical Devices Directive 93/42/EEC. 3) ... File and the Directive . The requirements for Annex IV Machinery ...

http://www.intertek.com/uploadedFiles/Intertek/Divisions/Commercial_and_Electrical/Media/PDF/Industrial/Guidance-Machinery-Directive.pdf

Date added: April 13, 2013 - Views: 6

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EC Declaration of Conformity to Medical Devices ...

EC Declaration of Conformity to Medical Devices Directive 93/42/EEC Manufacturer: Address ... EC Declaration of Conformity to Medical ... Annex VII elements are in ...

http://www.visbion.com/wp-content/uploads/2013/08/043_97128-EC-Declaration-of-Conformity-Iss8.pdf

Date added: September 26, 2013 - Views: 1

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

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: March 20, 2015 - Views: 12

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Directive 93/42/EEC - Research Instruments

EC Certificate Full Quality AssuranceSystem: GB98/13044, continued Research Instruments Ltd Directive 93/42/EEC on medical devices, Annex II (excluding section 4)

http://www.research-instruments.com/wp-content/uploads/RI-MDD-CE-iss-14.pdf

Date added: January 31, 2015 - Views: 1

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L 105/18 Official Journal of the European Union...

(11) Annex I to Directive 93/42/EEC sets out the essential requirements that medical devices must meet pursuant to that Directive. Points 8.1 and 8.2 of that Annex set

http://www.lne.eu/publications_en/directives/03-32e.pdf

Date added: September 12, 2013 - Views: 2

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sterimedix.com

SGS EC Certificate Full Quality Assurance System: GB97/9964, continued Sterimedix Ltd Directive 93/42/EEC on medical devices, Annex Il (excluding section 4)

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

Date added: October 9, 2015 - Views: 1

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EC Certificate TlfVRheinland - CeramOptec

A EC Certificate TlfVRheinland Directive 93/42/EEC Annex II, excluding Section 4 Full Quality Assurance System ÜVledical Devices Registration No.: HD 60101585 ...

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

Date added: May 1, 2016 - Views: 1

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Ultravision International Ltd Directive 93/42/EEC

Directive 93/42/EEC ... Ultravision International Ltd Commerce Way, Leighton Buzzard, ... Directive 93/42/EEC on medical devices, Annex V

http://ultravision.co.uk/files/6113/6197/8755/UV_MDD_93_42_EEC_Directive.pdf

Date added: July 31, 2015 - Views: 1