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Annex 9 directive 93 / 42 / EEC amended, concerning ... - LNE ...

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Annex 9 directive 93 / 42 / EEC amended, concerning ... - LNE ...

B ANNEX IX CLASSIFICATION CRITERIA I. DEFINITIONS 1. Definitions for the classification rules 1.1. Duration Transient Normally intended for continuous use for less than 60 minutes.

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

Date added: November 29, 2011 - Views: 14

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MEDICAL DEVICES Guidance document Classification of medical ...

guidelines relating to the application of . the council directive 93/42/eec on medical devices

http://ec.europa.eu/health/medical-devices/files/meddev/2_4_1_rev_9_classification_en.pdf

Date added: January 29, 2012 - Views: 49

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GUIDELINES ON MEDICAL DEVICES - MedDev

7 of directive 90/385/EEC and section I.1a of Annex X of directive 93/42/EEC ). Any such justification will have to be based on a proper clinical evaluation. Depending on clinical claims, risk management outcome and on the results of the

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

Date added: March 6, 2013 - 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 Anaesthetic Gás Scavenging Systems ULTRASEG Medicai Vacuum Systems ULTRAVAC Medicai Compressed Air Systems MEDIAR & ULTRAAR Medicai Oxygen Supply Systems ULTRAOX

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

Date added: November 26, 2013 - Views: 2

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ESSENTIAL REQUIREMENTS CHECKLIST - MEDICAL DEVICE DIRECTIVE ...

reproduction, in accordance with Annex I to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions ... ESSENTIAL REQUIREMENTS CHECKLIST - MEDICAL DEVICE DIRECTIVE 93/42/EEC COMPANY:

http://www.topra.org/sites/default/files/er_checklist_090925.pdf

Date added: September 17, 2013 - Views: 6

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

B COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic

http://www.emergogroup.com/files/EUROPE-CONSOLIDATED-MDD-93-42-EEC.pdf

Date added: November 21, 2012 - Views: 3

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IMPLEMENTATION OF DIRECTIVE 2007/47/EC AMENDING DIRECTIVES 90 ...

classification rules (Annex IX of Directive 93/42/EEC), new certification in accordance with the conformity assessment procedure applicable to the reclassified device is necessary for devices placed on the market or put into service as of 21 March 2010. 4.

http://ec.europa.eu/health/medical-devices/files/guide-stds-directives/transitionalperiod_2007-47-ec_guidance_final_en.pdf

Date added: May 5, 2012 - Views: 5

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INFORMATION ON TERUMO MEDICAL DEVICES AND PHTHALATES (DEHP ...

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/terumo/_pdf/medical-devices-containing-phthalates.pdf

Date added: September 9, 2012 - Views: 4

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KiranMedicalSystemsLimited Directive 93/42/EEC

Directive93/42/EEC onmedical devices, Annex V For the following products Sterile Radiation Protection Gloves, ... Directive 93/42/EEC on medical devices, Annex V For the following products Sterile Radiation Protection Gloves, Sterile Radiation shield.

http://www.kiranxray.com/certificate/CE_0120_RPG-1.pdf

Date added: July 3, 2013 - Views: 3

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OneFit Medical Directive 93/42/EEC

EC Certificate Full Quality Assurance System: FR12/00999, continued/suite OneFit Medical Directive 93/42/EEC on medical devices, Annex Il (excluding section 4)

http://www.onefit-medical.com/assets/files/Certificat_CE.pdf

Date added: January 4, 2014 - Views: 1

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www.p3-medical.com

EC Certificate Production Quality Assurance System: Certificate CBI 2/86101, continued P3 Medical Limited Directive 93/42/EEC on medical devices, Annex V

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

Date added: March 16, 2014 - Views: 1

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Directive 93/42/EEC - Purple Surgical

EC Certificate Production Quality Assurance System: Certificate GB11/83845, continued Purple Surgical International Limited Directive 93/42/EEC on medical devices, Annex V

http://www.purplesurgical.com/images/stories/documents/ce_directive_9342_eec.pdf

Date added: July 3, 2013 - Views: 4

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Labelling of medical devices containing phthalates - Eucomed

The revised Medical Device Directive 93/42/EEC as amended by Directive 2007/47/EC has included new ... category 1 or 2, in accordance with Annex I of Directive 67/548/EEC, and the device is intended to administer and/or remove medicines, ...

http://www.eucomed.org/uploads/Press%20Releases/Eucomed%20Recommendation%20on%20labelling%20of%20medical%20devices%20containing%20phthalates.pdf

Date added: January 30, 2012 - Views: 12

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G & H Wire Directive 93 / 42 / EEC Silicone Rubber: Non-latex ...

Directive 93/42/EEC Silicone Rubber: Non-latex Intraoral Elastic Bands, Orthodontic Wires, Orthodontic Springs, Temporary Orthodontic Implant Screws, Orthodontic Expanders, Ligature Wires, Otthodontic Bands, Orthodontic Tubes, and

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

Date added: November 3, 2013 - Views: 2

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Medical device directive 93/42/EEC and the revision 2007/47/EC

Medical device directive 93/42/EEC and the revision 2007/47/EC The changes (Amendment 2007/47/EC) to the current EC Medical Device Directive 93/42/EEC become mandatory on March 21,

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

Date added: July 17, 2013 - Views: 2

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EC Certificate - Dentsply Implants

" 0 EC Certificate EC Design-Examination Certificate Directive 93/42/EEC on Medical Devices (MDD), Annex II (4) (Devices in Class 111) No. G7 13 06 81854 007

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: 2

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

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 System

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

Date added: January 4, 2014 - Views: 1

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

the European Directive 93/42/EEC on Medical Devices . Basic Information MDD 93/42/EEC ... labeling as outlined in Annex I of the MDD. Safety requirements are not restricted to patients but include users and, where applicable, other persons.

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: 3

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GUIDANCE ON THE COMMISSION DIRECTIVE ON THE RECLASSIFICATION ...

AIM OF THE DIRECTIVE 6. The purpose of the Directive is to provide by way of derogation from the general classification rules of Annex IX of the Medical Devices Directive 93/42/EEC, for

http://www.mhra.gov.uk/home/groups/es-era/documents/websiteresources/con2031594.pdf

Date added: April 2, 2013 - Views: 3

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

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: 1

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APPROVAL EC Directive 93/42/EEC Annex Il, Article 3 Full ...

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

http://eng.astar.pl/wp-content/uploads/sites/2/2012/12/Certyfikat_EC_MDD_Annex_II_EN.pdf

Date added: March 9, 2014 - Views: 1

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Directive 93/42/EEC - Ultra-Controlo

Directive 93/42/EEC on medicai devices, Annex II (excluding Section 4) Forthefollowing proflucts MEDICAI VACUUM SYSTEM, MEDICAL COMPRESSED AIR SYSTEM, MEDICAI OXYGEN SUPPLY SYSTEM For placing on the market of Class III devices covered by this certjficate, an EC Design Examination

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

Date added: July 3, 2013 - Views: 2

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www.p3-medical.com

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

vi Text of Directive 93/42/EEC -----27 Annex I Essential Requirements -----47 Annex II EC Declaration of Conformity -----

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

Date added: February 28, 2012 - Views: 16

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

Directive 93/42/EEC . Copyright © 2012 BSI. All rights reserved. 4 New Regulation – No ??/2015 . Copyright © 2012 BSI. All rights reserved. 5 Medical Device. ... requirements of Annex I of Directive 2001/83/EC of the European Parliament

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

(Annex V of the Directive 93/42/EEC on Medical Devices) We hereby declare that an examination has been carried out following the requirements of the national legislation to which the undersigned is subject, transposing annex V of the Directive 93/42/EEC on medical

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

Date added: December 6, 2011 - Views: 20

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Medical Device Directive Certificate - Terumo

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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COUNCIL OF THE EUROPEAN UNION 15734/13 MI 962

used in Directive 93/42/EEC class IIa and IIb mobile medical devices other than portable emergency defibrillators . Delegations will find attached document C(2013) 6835 final. Encl.: C(2013) 6835 final . ... the Annex IV to Directive

http://register.consilium.europa.eu/doc/srv?l=EN&f=ST%2015734%202013%20INIT

Date added: May 1, 2014 - Views: 2

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

COMMISSION DIRECTIVE 2003/12/EC of 3 February 2003 on the reclassification of breast implants in the framework of Directive 93/42/EEC concerning

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

Date added: October 4, 2012 - Views: 2

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European Medicines Agency recommendation on the procedural ...

are described in Annex I, Section 7.4, of Directive 93/42/EEC as amended and Annex I, Section 10 of Directive 90/385/EEC as amended respectively, where their second paragraphs state that: “Where a device incorporates, as an integral part, a substance which, if used separately, may be

http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500123441

Date added: May 10, 2014 - Views: 1

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EC Certificate - Drendel

A.. ® EC Certificate TUVRheinland Directive 93/42/EEC Annex 11, excluding Section 4 Full Quality Assurance System Medical Devices Registration No.: HO 60089620 0001

http://www.drendel.com/fileadmin/user_upload/downloads/Zertifikate/2014/Richtlinie_93_42_Anhang_II_Englisch.pdf

Date added: March 19, 2014 - Views: 1

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. COUNCIL DIRECTIVE 93 /22/ EEC - Europa - Esma |

.COUNCIL DIRECTIVE 93/22/EEC of 10 May 1993 on investment services in the securities field THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the

http://www.esma.europa.eu/system/files/Dir_93_22.PDF

Date added: January 16, 2013 - Views: 3

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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? Medical Device means any instrument, ... to the essential requirements of Annex I of the Directive and issues a type examination certificate. Annex IV: EC verification

http://www.tuev-sued.de/uploads/images/1384776341055526320183/council-directive-93-42-eec.pdf

Date added: April 10, 2014 - Views: 2

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Experience with Directive 93 / 42 / EEC (MDD )

Experience with Directive 93/42/EEC (MDD) A medical device manufacturer’s retrospective view on 19 years of experience with Directive 93/42/EEC

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

Date added: July 3, 2013 - Views: 1

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ISO Med s.a.r.1. Directive 93/42/EEC - FBMedical

EC Certificate Full Quality Assurance System: FROO/51371.00, continued/suite ISO Med s.a.r.l. Directive 93/42/EEC on medical devices, Annex Il (excluding section 4)

http://www.fbmedical.fr/qualite/pdf/2_CE_ISO%20Med.pdf

Date added: April 18, 2014 - Views: 2

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of the Directive 93/42/EEC concerning medical devices No. MD ...

EC CERTIFICATE OF CONFORMITY Production quality assurance system, Annex V of the Directive 93/42/EEC concerning medical devices No. MD - 220/1/2009

http://www.mensor.pl/declaration_of_conformity_ce.pdf

Date added: December 6, 2012 - Views: 3

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ANNEX II.3 Directive 93/42/EEC - Meridian

C e r t i f i e d M a n a g e m e n t S y s t e m s Si t erand b y ANNEX II.3 Directive 93/42/EEC This Appendix is valid only in connection with the following certificate:

http://www.meridian.ch/fileadmin/media/pdf/zertifikate/105193_en_9001_13485_app_anh_12_03.pdf

Date added: February 17, 2014 - Views: 2

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EC Certification - Henry Schein Brand

Directive 93/42/EEC for Medical Devices, Annex V (OBL) ... AMTAC Certification Services Limited is a Notified Body according to Directive 93/42/EEC for medical devices, with identification number 0473. This Certificate is for the e.

http://www.henryscheinbrand.com/WEFiles/File/IntertekV.pdf

Date added: July 6, 2013 - Views: 1

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EC Certification - West Pharma

Directive 93/42/EEC for Medical Devices, Annex V . ... AMTAC Certification Services Limited is a Notified Body according to Directive 93/42/EEC for medical devices, with identification number 0473. Certificate Number: Initial Certification Date:

http://www.westpharma.com/en/products/Documents/Intertek%20Annex%20V%20limited%20to%20sterility%20certificate%20346%20CE.pdf

Date added: January 15, 2014 - Views: 1

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EC Declaration of Conformity to Medical Devices Directive 93 ...

Annex II elements are in conformity with ISO13485:2003 requirements as verified by Notified Body ... EC Declaration of Conformity to Medical Devices Directive 93/42/EEC Manufacturer: Address: Visbion Ltd Visbion House Gogmore Lane Chertsey KT16 9AP UK

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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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: 3

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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 111)

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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EC Certificate - Allied Healthcare Products, Inc.

EC Certificate FULL QUALITY ASSURANCE SYSTEM Directive 93/42/EEC on IVledical Devices, Annex II (3) Certificate Number 41316939-01 initial Certification Date

http://www.alliedhpi.com/images/AHPI_CE.pdf

Date added: July 8, 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/download_pdf/Directive-93-42-EEC.pdf

Date added: March 16, 2014 - Views: 1

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www.technovent.com

EC Certificate Full Quality Assurance System: GB98/12403, continued Technovent Limited and Principality Medical Limited Directive 93/42/EEC on medical devices, Annex Il (excluding section 4)

http://www.technovent.com/DIR%2093-42-eec%20annex%202%20exp%2017092015.pdf

Date added: May 10, 2014 - Views: 1

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AT SERTiFiKASI According to Annex II of the Directive 93/42 ...

According to Annex II of the Directive 93/42/EEC on Medical Devices CE . EC CERTIFICATE , 2195 . AT SERTiFiKASI . 93/42/A T Yonetmeligi(T/bbi Cihaz), EK li'ye gore

http://www.agorakimya.com.tr/images2/sistem_belgelerimiz/ce_2195_med_07010004_rev_01.pdf

Date added: July 3, 2013 - Views: 1

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Notified Body for Medical Devices Directive 93/42/EEC

Directive 93/42/EEC VTT, NOTIFIED BODY NO 0537 VTT has a long experience as a Notified Body under the Medical Devices Directive. ... (Annex II) EC design examination (Annex II, 4) Manufacturer's option Manufacturer's option EC verification (Annex IV) Production quality

http://www.vttexpertservices.fi/files/services/exp/brochures_eng/mdd_brochure.pdf

Date added: December 16, 2013 - Views: 1

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Page 1/1

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

http://accuro.pl/portal/certyfikat-ec.pdf

Date added: May 19, 2014 - Views: 1

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EC Certification - Henry Schein Brand

Directive 93/42/EEC for Medical Devices, Annex II (OBL) ... AMTAC Certification Services Limited is a Notified Body according to Directive 93/42/EEC for medical devices, with identification number 0473. AMTAC Certification Services Limited, ...

http://www.henryscheinbrand.com/WEFiles/File/CE%20Certificate_Annex%20II%20.pdf

Date added: January 4, 2014 - Views: 1

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QS Certificate Quality Assurance System Directive 93/42/ECC ...

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: 1