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

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

MDD: THE MEDICAL DEVICES DIRECTIVE 93/42/EEC INCLUDING DIRECTIVE 2007/47/EC.....6 MEDICAL DEVICE ... labeling as outlined in Annex I of the MDD.

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: 4

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MEDICAL DEVICES Guidance document Classification of medical ...

In order to ensure that conformity assessment under the Medical Device Directive functions ... rules’ and are set out in Annex IX of Directive 93/42/EEC.

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

Date added: January 29, 2012 - Views: 52

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

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

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 ...

appropriate to amend <b>Directive</b> <b>93</b>/<b>42</b>/<b>EEC</b>, Council <b>Directive</b> 90/385/<b>EEC</b> of ... under <b>Annex</b> VIII to <b>Directive</b> <b>93</b>/<b>42</b>/<b>EEC</b> is also to be given to the patient and that it

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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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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Directive 93/42/EEC - Ultra-Controlo,ar medicinal,vácuo ...

Directive 93/42/EEC on medicai devices, Annex II (excluding Section 4) For the followmg products ... 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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GUIDELINES ON MEDICAL DEVICES - MedDev

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. ... (MEDDEV 2.12/2: ...

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

Medical device directive 93/42/EEC and the revision 2007/47/EC The changes (Amendment 2007/47/EC) ... Directive include: Clinical data (Annex X) is required for all

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

Date added: July 17, 2013 - Views: 2

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Content of mandatory certificates - MedDev INFO - MEDICAL ...

(Annex VI of the Directive 93/42/EEC on Medical Devices) We hereby declare that an examination of the under mentioned product quality system has been carried out

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

Date added: December 6, 2011 - Views: 21

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

Medical Devices Directive (93/42/EEC) • Annex II Full Quality Assurance ... Active implantable devices covered by Directive 90/385/EEC; ...

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

Date added: November 26, 2013 - Views: 4

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Labelling of medical devices containing phthalates

The revised Medical Device Directive 93/42/EEC as amended by Directive 2007/47/EC has included new ... Directive’s Essential Requirements (Annex 1) section 7.5.

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

Directive 93/42/EEC . Copyright © 2012 BSI. All rights reserved. 4 New Regulation ... 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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DENTSPL V lmplants NV Directive 93/42/EEC

EC Certificate Full Quality Assurance System: BE06/761247, continued DENTSPL V lmplants NV Directive 93/42/EEC on medical devices, Annex II (excluding section 4)

http://www.dentsplyimplants.com/~/media/M3%20Media/DENTSPLY%20IMPLANTS/1223600%20DENTSPLY%20Implants%20NV%20CE%20Certificate%20Annex%20II%20SimPlant%20software%20platform.ashx?filetype=.pdf

Date added: December 28, 2014 - Views: 1

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COUNCIL DIRECTIVE 93/6/EEC - Esma |

COUNCIL DIRECTIVE 93/6/EEC of 15 March 1993 ... Annex to Directive 93/22/EEC until the warrant's expiry date; 17. Repurchase agreement and reverse

http://www.esma.europa.eu/system/files/Dir_93_6.PDF

Date added: August 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)

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

Date added: January 4, 2014 - Views: 1

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EC Certificate - DENTSPLY Implants, Dental products, dental ...

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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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 ...

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 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 ...

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

Date added: January 4, 2014 - Views: 1

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Med-Info Council Directive International expert information ...

Council Directive 93/42/EEC on Medical Devices Diagnosis, prevention, monitoring, ... Annex IX of the Directive stipulates the classification

http://www.tuv-sud.com/uploads/images/1384776341055526320183/council-directive-93-42-eec.pdf

Date added: December 8, 2013 - Views: 6

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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 ...

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

Date added: November 3, 2013 - Views: 2

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www.p3-medical.com

Directive 93/42/EEC on medical devices, ... Directive 93/42/EEC on medical devices, Annex V Restricted to the aspects of manufacture concerned with securing and

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.3 Directive 93/42/EEC - Meridian AG: Home

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 ...

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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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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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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NBOG’s Best Practice Guide AIMDD, 2010- 3

Table 4 Possible certificates for Notified Bodies under Directive 90/385/EEC ... 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: 19

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Directive 93/42/EEC - Ultra-Controlo,ar medicinal,vácuo ...

Directive 93/42/EEC on medicai devices, Annex II (excluding Section 4) Forthefollowing proflucts ... 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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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

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

Date added: July 3, 2013 - Views: 3

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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 ...

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

Date added: February 28, 2012 - Views: 17

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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: 5

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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 ... point 4 of Annex II to Directive 93/42/EEC.

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

Date added: October 4, 2012 - 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/pdf/2_CE_ISO%20Med.pdf

Date added: January 31, 2015 - Views: 1

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TÜVRheinland EC Certificate Directive 93/42/EEC Annex Il ...

TÜVRheinland EC Certificate Directive 93/42/EEC Annex Il, excluding Section 4 Full Quality Assurance System Manufacturer: Registration No.: Report No.:

http://eng.astar.pl/wp-content/uploads/sites/2/2012/12/Astar-Certificate-EC-12-12-20141.pdf

Date added: March 5, 2015 - Views: 1

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.COUNCIL DIRECTIVE 93/22/EEC - Esma |

.COUNCIL DIRECTIVE 93/22/EEC of 10 May 1993 ... 42, 22. 2. 1990, p. 7. ... Annex to this Directive. (9) OJ No L 193, 18. 7.

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

Date added: January 16, 2013 - Views: 3

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

Directive 93/42/EEC, Annex Il for the design, ... QS Certificate Quality Assurance System Directive 93/42/ECC, Annex II Author: Memmert GmbH +Co. KG Created Date:

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

Date added: March 16, 2014 - Views: 1

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Spellman High Voltage Electronics GmbH - EC Certificate ...

Title: Spellman High Voltage Electronics GmbH - EC Certificate Directive 93/42/EEC, Annex II Excluding (4) Subject: Spellman High Voltage Electronics GmbH has a full ...

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

Date added: October 22, 2014 - Views: 1

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Certification of Medical Devices according to Directive 93/42/EEC

according to the 93/42/EEC MD Directive* and, when relevant, ... carried out in line with relevant annex/es to the MDD 93/42/EEC Directive; their selection

http://www.siq.si/index.php?eID=tx_nawsecuredl&u=0&file=fileadmin/siqnew/osv/DOKUMENTI/MDD_DP006E.pdf&t=1424331056&hash=04de04dc564dd3addd156d6db44c7350f65a2f03

Date added: February 19, 2015 - Views: 1

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Directive 93/42/EEC - SLE

Directive 93/42/EEC on medical devices, Annex II (excluding Section 4) For the following ... Annex (Section 4) is required. This certificate is valid from 23

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

Date added: September 24, 2014 - 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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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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Page i - Graphic Controls

... Graphic Controls Operations . ... Reference MDD Annex V in scope, ... Medical Device Directive 93/42/EEC including Amendment 2007/47/EC

http://www.graphiccontrols.com/Images/1-42-01.pdf

Date added: May 13, 2013 - Views: 3

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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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COUNCIL DIRECTIVE - Omnex | Quality and Business Management ...

amending Directive 90/385/EEC. The amendments introduced by Directive 93/42/EEC ... * Annex II, section 2, second

http://www.omnex.com/training/iso13485/europe/Active-Implantable-Directive-90-385-EEC.pdf

Date added: November 26, 2013 - Views: 4

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Annex II of Directive 93 42 EEC - Mesa - Mesa Medizintechnik ...

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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Understanding the Machinery Directive ( 2006 / 42 / EC )

Directive 2006/42/EC ... by the Medical Devices Directive 93/42/EEC. 3) ... Technical File and the Directive . The requirements for Annex IV Machinery using ...

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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according the directive 93/4 Annex II excluding

according the directive 93/4 Annex II excluding secti ... directive 93/42/EEC annex IL The approval is_ based on_ th_e result of. the r~-certification audit ...

http://www.pulsion.com/fileadmin/pulsion_share/Company/QualityAssurance/2014__EN_Anhang_CECertificate_EN_rev01.pdf

Date added: November 27, 2014 - 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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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

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

Date added: May 1, 2014 - Views: 5

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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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Application for performance/change/extension of a conformity ...

Application for performance/change/extension of a conformity assessment procedure in accordance with Council Directive 93/42/EEC ... Annex II without (4) ...

http://www.tuv-sud.com/uploads/images/1396968529474615381356/mdd-application-for-performance-change-extension-of-a-conformity-assessment-procedure-in-accordance-with-council-directive-93-42-eec-mdd.pdf

Date added: May 1, 2014 - Views: 1