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MEDICAL DEVICES Guidance document Classification of medical ...

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MEDICAL DEVICES Guidance document Classification of medical ...

In order to ensure that conformity assessment under the Medical Device Directive functions effectively, ... These are referred to as the ‘classification rules’ and are set out in Annex IX of Directive 93/42/EEC. They correspond, to a large extent, to the classification rules

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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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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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 ... Certificate according to Annex II (Section 4) is required.

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 ...

ESSENTIAL REQUIREMENTS CHECKLIST - MEDICAL DEVICE DIRECTIVE 93/42/EEC COMPANY: ... ESSENTIAL REQUIREMENTS CHECKLIST - MEDICAL DEVICE DIRECTIVE 93/42/EEC ... in accordance with Annex I to Directive 67/548/EEC, these

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 ...

meaning of Directive 93/42/EEC (*) and if it satisfies the essential requirements laid down therein for that device, ... 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/files/EUROPE-CONSOLIDATED-MDD-93-42-EEC.pdf

Date added: November 21, 2012 - Views: 3

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GUIDELINES ON MEDICAL DEVICES - MedDev

MEDDEV 2.7/4 December 2010 GUIDELINES ON MEDICAL DEVICES ... investigations laid out in annex 7 of directive 90/385/EEC and in annex X of directive 93/42/EEC as amended by directive 2007/47/EC. The clinical investigations shall be

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

Date added: March 6, 2013 - Views: 1

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

current EC Medical Device Directive 93/42/EEC become mandatory on March 21, 2010. By March 21, ... Directive include: Clinical data (Annex X) is required for all products (independent of classification, including Class I devices) and from every

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

Date added: July 17, 2013 - Views: 2

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

Directive 2007/47/EC amends Directive 90/385/EEC on active implantable medical devices and Directive 93/42/EEC on medical devices. The changes concern, among others, ... (Annex IX of Directive 93/42/EEC), new certification in accordance

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: 6

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

Basic Information MDD 93/42/EEC 040100/6 Page 2 of 20 © mdc / 2009-11-13 PREFACE This booklet is intended to provide an introduction to the principles of European ‘New Approach

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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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 ... The new requirements are set out in the Directive’s Essential Requirements (Annex 1) section 7.5. ... Symbol for "CONTAINS or PRESENCE of PHTHALATES”: Dibutyl phthalate (DBP) or .

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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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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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 Devices Directive (93/42/EEC) Active Implantable ...

Medical Devices Directive (93/42/EEC) • Annex II Full Quality Assurance ... is defined in Directive (93/42/EEC) as: Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the

http://www.iregqms.com/files/EU%20Medical%20Device%20CE%20mark%20process.pdf

Date added: November 26, 2013 - Views: 1

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Directive 93/42/EEC - Purple Surgical - Welcome

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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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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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 ... Certificate according to Annex II (Section 4} is required.

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

Date added: July 3, 2013 - Views: 2

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

Existing Directive93/42/EEC . Copyright © 2012 BSI. All rights reserved. 3 Directive 93/42/EEC . Copyright © 2012 BSI. ... Article 42 Point 4 Annex VIII Technical Doc . Vigilance System Full Quality Assurance Annex X Batch Verification .

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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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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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: 4

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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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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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mipm.com

Directive 93/42/EEC on medical devices, ... Richtlinie 93/42/EEC Für Medizinprodukte, Beilage Il (ausgenommen Sektion 4) For the following products I Die Zertifizierung umfasst ... Cerüficate according to Annex Il (Section 4) is required.

http://mipm.com/dokument/QS_Certificate_Quality_Assurance_System_Directive_93-42-EEC%2C_Annex_II_excluding_%284%29_1392197743_1110.pdf

Date added: March 19, 2014 - 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_EN1.pdf

Date added: April 10, 2014 - Views: 1

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

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) is not applicable to the following products:

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

Date added: February 28, 2012 - Views: 16

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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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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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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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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, where their third paragraphs state that: “Where a device incorporates, as an integral part, a human blood derivative, the notified body shall,

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

on the reclassification of breast implants in the framework of Directive 93/42/EEC concerning medical devices (Text with EEA relevance) ... By way of derogation from the rules set out in Annex IX to Directive 93/42/EEC, breast implants shall be reclassified as medicaldevicesfallingwithinClassIII.

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

Date added: October 4, 2012 - Views: 2

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

.COUNCIL DIRECTIVE 93/22/EEC of 10 May 1993 ... 42, 22. 2. 1990, p. 7.((2) OJ No C 304, 4. 12. 1989, p. 39; and OJ No C 115, 26. 4. ... 93/22/EEC 10/05/93 ANNEX SECTION A Services 1. (a) Reception and transmission, on behalf of investors, ...

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 Lübeck, ... MDD Annex I, Clause 9.1: If the device is intended for use in combination with other devices or equipment, the

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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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 section 4)

http://www.medicontur.com/files/Quality_assurance/2014/Directive_93_42_EEC_Annex2.pdf

Date added: August 8, 2014 - Views: 1

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www.biodenta.com

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

http://www.biodenta.com/downloads/certificates/BDCH_93_42_EEC_Annex_II_Dental_Implant_System_en.pdf

Date added: August 8, 2014 - 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 III) Full quality assurance (Annex II) EC design examination (Annex II, 4) Manufacturer's option Manufacturer's option EC

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

Date added: December 16, 2013 - Views: 1

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

... Visbion EC Declaration of Conformity Issue 8 ... Annex II elements are in conformity with ISO13485:2003 requirements as verified by ... EC Declaration of Conformity to Medical Devices Directive 93/42/EEC Manufacturer: Address: Visbion Ltd Visbion House Gogmore Lane

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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www.medicontur.com

EC Certificate Production Quality Assurance System: Certificate HU14/7099, continued MEDICONTUR MEDICAL ENGINEERING Directive 93/42/EEC on medical devices, Annex V

http://www.medicontur.com/files/Quality_assurance/2014/Directive_93_42_EEC_Annex5.pdf

Date added: August 8, 2014 - Views: 1

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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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EC Certification - West Pharma

... and then only in accordance with the agreed upon Certification ... Directive 93/42/EEC for Medical Devices, Annex V . ... transposing Annex V of the Directive 93/42/EEC on medical devices.

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 Certification - Henry Schein Brand

Directive 93/42/EEC for Medical Devices, ... Annex V of the Directive 93/42/EEC on medical devices via an Own Branding arrangement. We certify that the ... The certificate remains the property of Intertek, to whom it must be returned upon request.

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

Date added: July 6, 2013 - 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: 2

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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 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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LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical ...

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 Annex VI Class Ilb active devices for administering gas and/or extracting medicines/substances

http://obelis.net/docs/MDD-notified_body.pdf

Date added: January 7, 2013 - Views: 2