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MEDICAL DEVICES Guidance document Classification of medical ...

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MEDICAL DEVICES Guidance document Classification of medical ...

... assessment is the method by which a manufacturer demonstrates that their devices comply with the requirements of Directive 93/42/EEC. The classification of the medical device will have an ... performances referred to in sections 1 and 3 of Annex I of Directive 93/42/EEC under the normal ...

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 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL ...

amending Council Directives 90/385/EEC and 93/42/EEC and Directive 98/8/EC of the ... carried out in accordance with the procedure set out in Annex VIII to Directive 93/42/EEC, and (iii) design examination and EC type examination of medical devices that incorporate, ...

http://ec.europa.eu/health/medical-devices/files/revision_docs/entr-2005-01983-01-00-en_en.pdf

Date added: November 30, 2012 - Views: 2

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ESSENTIAL REQUIREMENTS CHECKLIST - MEDICAL DEVICE DIRECTIVE ...

ESSENTIAL REQUIREMENTS CHECKLIST - MEDICAL DEVICE DIRECTIVE 93/42/EEC COMPANY: ... 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

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

Date added: September 17, 2013 - Views: 6

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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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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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www.p3-medical.com

Directive 93/42/EEC on medical devices, Annex V ... Directive 93/42/EEC on medical devices, Annex V Restricted to the aspects of manufacture concerned with securing and maintaining sterile conditions. Issue 2 Detailed scope

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 - 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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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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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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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 requirements for medical devices containing certain phthalates. ... in accordance with Annex I of Directive 67/548/EEC, ...

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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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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KiranMedicalSystemsLimited Directive 93/42/EEC

Directive93/42/EEC onmedical devices, Annex V For the following products ... Directive 93/42/EEC on medical devices, Annex V For the following products Sterile Radiation Protection Gloves, ... Twinkle Vaz Created Date:

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

Date added: July 3, 2013 - Views: 3

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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 - 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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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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OneFit Medical Directive 93/42/EEC

Directive 93/42/EEC on medical devices, Annex Il (excluding Section 4) Directive 93/42/EEC on medical devices, Annexe Il (section 4 exclue) For the following products/Pour les produits suivants The scope of registration appears on page 2 of this certificate.

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

Date added: January 4, 2014 - Views: 1

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EC Certificate TUVRheimaS-ij | - Terumo Medical ...

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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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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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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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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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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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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e ii dir 93 42 eec

EC CERTIFICATE for the Quality Assurance System according the directive 93/42/ËEC, Annex Il excluding section (4) As a notified body of the European Union.

http://cdn.atmosmed.com/docs/14974/e_ii_dir_93_42_eec_2.pdf

Date added: September 24, 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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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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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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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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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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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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ANNEX II.3 Directive 93/42/EEC

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 its design,

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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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 . ... the Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for

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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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/2014/2014_augusztus/Directive%2093_42_EEC_Annex%20II.pdf

Date added: September 24, 2014 - Views: 1

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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,%20Annex%20II.pdf

Date added: September 24, 2014 - Views: 1

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Directive 93/42/EEC

Directive 93/42/EEC on medical devices, Annex II (excluding Section 4) For the following products Lung Ventilators. CPAP Drivers and nCPAP ... Annex (Section 4) is required. This certificate is valid from 23 September 20tl until 08 April 2016 and remains valid subject to

http://www.sle.co.uk/files/library/files/products/brochures/CE%20cert.pdf

Date added: September 24, 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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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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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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.COUNCIL DIRECTIVE 93/22/EEC - Europa

.COUNCIL DIRECTIVE 93/22/EEC of 10 May 1993 ... Directive 93/6/EEC of 15 March 1993 on the ... 93/22/EEC 10/05/93 ANNEX SECTION A Services 1. (a) Reception and transmission, on behalf of investors, of orders in relation to one or more of

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

Date added: January 16, 2013 - Views: 3

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Annex V of the Directive 93/42/EEC

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 CertificatjonGrnbHcertifieSih th

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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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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Full page fax print

on the basis Of our examination under the requirements of Council Directive 93/42/EEC, Annex Il, Section 3.2. For and on behalf of the British Standards Institution, ... Validity Of this certificate is conditional on the quality system being maintained to the requirements Of the Directive.

http://www.neovasc.com/tissue-products/documents/BSI-EC-Directive-93-42-EEC-AnnexII-Article-3.pdf

Date added: September 24, 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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www.medicontur.com

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

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

Date added: September 24, 2014 - Views: 1

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Council Directive 93/42/EEC Concerning Medical Devices

Council Directive 93/42/EEC Concerning Medical Devices We, dHAL Software, with offices at 6 Menandrou Street ... is in conformity with the applicable requirements of Council Directive 93/42/EEC Annex V concerning medical devices. Notified Body: National Evaluation Center of Quality ...

http://www.dhal.com/downloads/viewboxdeclarationconformity2014.pdf

Date added: September 24, 2014 - Views: 1

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

EC Declaration of Conformity to Medical Devices Directive 93/42/EEC Manufacturer: Address Visbion Ltd Visbion House Gogmore Lane Chertsey KT16 9AP UK Telephone +44 (0)870 850 3486 ... Annex VII elements are in conformity with ISO13485:2003 requirements

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.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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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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www.peplacey.com

Directive 93/42/EEC on medical devices, Annex Il (excluding Section 4) ... Certifiæte according to Annex Il (Section 4) is required, This cemcate is valid from 16 February 2014 until 16 December 2018 and remains valid subject to satisfactory surveillance audits.

http://www.peplacey.com/pdf/Directive-93-42-EEC-US10-81763.pdf

Date added: September 24, 2014 - 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