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CLASSIFICATION CRITERIA Definitions for the...

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CLASSIFICATION CRITERIA Definitions for the...

Definitions for the classification rules 1.1. Duration ... Annex 9 directive 93/42/EEC amended, concerning medical devices Subject: Medical devices, Directive

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

Date added: November 29, 2011 - Views: 18

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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: 16

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

B COUNCIL DIRECTIVE 93/42/EEC ... Annex I to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions

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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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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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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GUIDELINES ON MEDICAL DEVICES - European...

GUIDELINES ON MEDICAL DEVICES CLINICAL INVESTIGATIONS: SERIOUS ADVERSE EVENT REPORTING ... Annex X of Directive 93/42/EEC, as amended by Directive 2007/47/EC.

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

current EC Medical Device Directive 93/42/EEC become mandatory on March 21, ... Directive include: Clinical data (Annex X) is required for all products ...

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

Date added: July 17, 2013 - Views: 2

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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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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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DIRECTIVE 93/ 42/ EEC - CE Marking

DIRECTIVE 93/42/EEC . ... essential requirements of Annex I to the present Directive shall apply as far as safety and performance related device features are ...

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

Date added: May 17, 2013 - Views: 2

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

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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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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velfina.com

APPROVAL EC Directive 93/42/EEC Annex V, Article 3 Quality Assurance System Production -rÜVRheinland Manufacturer: Scope: Date of Expiry: Registration No.:

http://velfina.com/upload/certificates/Directive_93_42_EEC_Annex_V.pdf

Date added: September 24, 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.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 7, 2016 - Views: 1

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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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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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93. 42. EEC & 90.385. EEC New Regulation

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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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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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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www.polydentia.ch

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.polydentia.ch/fileadmin/Download_Documents/Directive_93_42_EEC.pdf

Date added: July 31, 2015 - Views: 1

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KMBT C654-20151210115438

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 7, 2016 - 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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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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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: July 31, 2015 - Views: 1

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

1 The Medical Device Directive1 2 3 Directive 93/42/EEC Applicable since June 1993 and mandatory since June 1998 To Be Considered: The Medical Device Directive (MDD ...

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

Date added: February 28, 2012 - Views: 17

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www.heisig.de

Manufacturer: Products: Expiry Date: EC Certificate Directive 93/42/EEC Annex V Production Quality Assurance Medical Devices TUVRheinland Registration No.:

http://www.heisig.de/fileadmin/user_upload/pdf/zertifizierung/EC-Certificate_MDD_93_42_EEC_Annex_V.pdf

Date added: June 12, 2015 - Views: 1

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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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Spellman High Voltage Electronics GmbH - EC...

... manufacturer and final inpsection of the medical devices as specified within the scope of X-Ray generators ... Directive 93/42/EEC Annex II Excluding ...

http://www.spellmanhv.com/~/media/Files/Downloads/Germany%2093_42_EEC.ashx

Date added: October 22, 2014 - Views: 1

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Ultravision International Ltd Directive 93/ 42/ ...

Directive 93/42/EEC on medical devices, Annex V ... Ultravision International Ltd ... Directive 93/42/EEC

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

Date added: July 31, 2015 - Views: 1

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www.medicontur.com

EC Certificate Full Quality Assurance System: HU14/7098, continued MEDICONTUR MEDICAL Engineering Ltd. Directive 93/42/EEC on medical devices, Annex Il (excluding ...

http://www.medicontur.com/files/Quality_assurance/2014/2014_augusztus/Directive%2093_42_EEC_Annex%20II.pdf

Date added: September 24, 2014 - Views: 1

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sterimedix.com

SGS Certificate GB97/9964, continued Sterimedix Ltd Directive 93/42/EEC Annex Il (excluding section 4), Annex V, Annex V (sterility aspects only),

http://sterimedix.com/pdf/Directive-93-42-EEC.pdf

Date added: September 24, 2014 - Views: 1

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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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ANNEX II Directive 93/ 42/ EEC (without section...

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

Ref. 201509 rev. 01 GUIDANCE DOCUMENT EU Medical Device Directive (93/42/EEC) labelling requirements Sterile Barrier Association, Pennygate House, St Weonards ...

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

Date added: February 7, 2016 - Views: 1

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TO COUNCIL DIRECTIVE 93/ 42/ EEC OF JUNE...

declaration of conformity to council directive 93/42/eec of 14 june 1993· concerning medical devices iii manufacturer: medical device: classification -annex ix:

http://www.viscot.com/download/Declaration%20of%20Conformity%2093.42.EEC%20June%201993.pdf

Date added: May 5, 2013 - Views: 5

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Directiva - medicontur.com

EC Certificate Full Quality Assurance System: HU14/7098, continued MEDICONTUR Medical Engineering Ltda Directive 93/42/EEC on medical devices, Annex Il (excluding ...

http://www.medicontur.com/files/Quality_assurance/2014_new_certies/Directive%2093_42_EEC_Annex%20II.pdf

Date added: October 25, 2014 - Views: 1

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

217 Rev 01 Council Directive 93/42/EEC Index Page 11 of 69 Indent Parag Annex Article Term Line L 3 III.1.2. IX 1Class I, in all other cases 5162 C1

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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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

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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QS Certificate Quality Assurance System Directive ...

Title: QS Certificate Quality Assurance System Directive 93/42/ECC, Annex II Author: Memmert GmbH +Co. KG Created Date: 7/17/2008 4:10:20 PM

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

Date added: March 16, 2014 - Views: 2

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www.velfina.ro

TÜVRheinland APPROVAL EC Directive 93/42/EEC; Annex Il without Article 4 Registration No.: Report No.: Manufacturer: Scope: Date of expiry: Full Quality Assurance System

http://www.velfina.ro/certificari/Directive%2093_42_EEC_annex%20II%201008_PansAg.pdf

Date added: March 16, 2014 - Views: 1

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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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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://obelismedical.net/wp-content/uploads/2014/12/Doc_Legislation_MD_2003.12.EC_.pdf

Date added: December 29, 2014 - Views: 1

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

Amendments to the MDD 93/42/EEC . TABLE OF CONTENTS . ... (Annex I) of the Machinery directive to the extent to which they are more specific than the ER of MDD ...

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

Date added: April 4, 2015 - Views: 1

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www.hagerwerken.de

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

http://www.hagerwerken.de/_uploads/media/23131_CE%20Approval%20Annex%20II%2093_42_EEC_GB%2005-2014.pdf

Date added: November 27, 2014 - Views: 1

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www.otopront.de

Manufacturer: Scope: APPROVAL EC Directive 93/42/EEC Annex Il, Article 3 Full Quality Assurance System Medical Devices TUVRheinland Registration No.:

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

Date added: April 18, 2014 - Views: 1