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Basic Information about the European Directive 93/...

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Basic Information about the European Directive 93/...

... VII of the Medical Devices Directive 93/42/EEC (MDD) Annex II ... mdc’s accreditation scope contains medical devices according to MDD 93/42/EWG and in vitro

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

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: 17

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MEDICAL DEVICES Guidance document Classification...

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: 65

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

Directive 2007/47/EC amends Directive 90/385/EEC on active implantable medical ... (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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B COUNCIL DIRECTIVE 93/ 42/ EEC of 14 June 1993...

meaning of Directive 93/42/EEC (*) ... accordance with Annex I to Directive 67/548/EEC, these devices must be labelled on the device itself and/or on the packaging for

http://www.emergogroup.com/sites/default/files/file/europe-consolidated-mdd-93-42-eec.pdf

Date added: April 2, 2015 - Views: 1

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

Medical Devices Directive (93/42/EEC) • Annex II Full Quality Assurance ... is defined in Directive (93/42/EEC) as: Any instrument, apparatus, appliance, ...

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

Date added: November 26, 2013 - Views: 4

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INFORMATION ON TERUMO MEDICAL DEVICES AND...

INFORMATION ON TERUMO MEDICAL DEVICES AND PHTHALATES ... Phthalates of Concerns and the Medical Device Directive 93/42/EEC ... Annex I of Directive 67/548/EEC ...

http://www.terumo-europe.com/terumo/_pdf/medical-devices-containing-phthalates.pdf

Date added: September 9, 2012 - Views: 4

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www.p3-medical.com

Directive 93/42/EEC on medical devices, Annex V Issue 3 Detailed scope Annex V ... Annex V Restricted to the aspects of manufacture concerns

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

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

Date added: November 26, 2013 - Views: 2

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Content of mandatory certificates - MedDev

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

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

http://www.quality-service.ch/pdf/Flyer_2007_47_EC_Vers01.pdf

Date added: February 29, 2012 - Views: 14

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93. 42. EEC & 90.385. EEC New Regulation

93.42.EEC & 90.385.EEC New Regulation Suzanne Halliday May 2013 . ... 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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Directive 93/ 42/ EEC - Research Instruments Ltd

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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Med-Info Council Directive International expert...

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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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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EC Certificate

" 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: 3

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

Directive 93/42/EEC on medical devices, Annex Il (excluding section 4) Directive 93/42/EEC on medical devices, Annexe Il (section 4 exclue) Issue / Version 13

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

Date added: January 31, 2015 - Views: 1

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NBOG’s Best Practice Guide AIMDD, 2010-3

Directive 93/42/EEC on Medical devices, Annex II excluding (4) ... NBOG BPG 2010-3 Page 35 of 35 Reference 93/42/EEC* Article 11, Annexes II-VI

http://www.nbog.eu/resources/NBOG_BPG_2010_3.pdf

Date added: December 6, 2011 - Views: 19

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Page i - Graphic Controls

Medical Device Directive 93/42/EEC including Amendment 2007/47/EC and Council Directive 80/181/EEC (1). DISTRIBUTION: ... Reference MDD Annex V in scope, Update

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

Date added: May 13, 2013 - Views: 7

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

ANNEX II.3 Directive 93/42/EEC This Appendix is valid only in connection with the following certificate: Registration Number 32730 ... 10/11/2012 12:03:42 PM ...

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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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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European Medicines Agency recommendation on the...

... Section 7.4, of Directive 93/42/EEC as amended and Annex I, ... the European Medicines Agency website at the time the notified body has reached a decision on the

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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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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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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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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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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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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Directiva - Medicontur

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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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,

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

Date added: July 3, 2013 - Views: 2

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

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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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.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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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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LIST OF BODIES NOTIFIED UNDER DIRECTIVE 93/ 42/ ...

Only devices mentioned in § B EC verification Annex IV PRÜF UND FORSCHUNGSINSTITUT E.V. ... LIST OF BODIES NOTIFIED UNDER DIRECTIVE 93/42/EEC Medical devices

http://avan.nl/wp-content/uploads/2014/10/Notified_Bodies_medische_hu11.pdf

Date added: June 30, 2015 - Views: 1

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QS Certificate Quality Assurance System Directive ...

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

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

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GE Healthcare 93/ 42/ EEC) We - ugap.fr | Votre...

Class lib according to Directive 93/42/EEC, Annex IX, ... directive 93/42/EEC) ... GE Healthcare ADDENDUM TO THE ...

http://www.ugap.fr/images/media-wp/2014/09/ofcf_ce-xr200.pdf

Date added: June 21, 2015 - Views: 1

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Full page fax print - Neovasc Inc.

on the basis Of our examination under the requirements of Council Directive 93/42/EEC, Annex Il, Section 3.2. ... Full page fax print Author: cwebb Created Date:

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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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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Understanding the Machinery Directive (2006/ 42...

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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Nolato Jaycare Directive 93/ 42/ EEC

Directive 93/42/EEC on medical devices, Annex V Restricted to the aspects of manufacture concerned with the ... Nolato Jaycare Directive 93/42/EEC Created Date:

http://www.nolato.com/downloads/pharma-certificates/med-dev-jaycare.pdf

Date added: May 14, 2015 - Views: 1

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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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www.terumomedical.com

Directive 93/42/EEC Annex Il, excluding Section 4 Full Quality Assurance System Medical Devices TÜVRheinland Manufacturer: Products: Expiry Date: Registration No.:

http://www.terumomedical.com/aboutus/93-42-EEC-color(nocover).pdf

Date added: January 8, 2013 - Views: 3

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gbukhealthcare.com

Directive 93/42/EEC on medical devices, Annex V For the following products Wound Drainage Systems ... Examination Certificate according to Annex Ill is required.

http://gbukhealthcare.com/wp-content/uploads/GBUK-Directive-93.42.EEC-AnnexV.pdf

Date added: March 15, 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

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www.purplesurgical.com

Directive 93/42/EEC on medical devices, Annex Il (excluding section 4) Issue 17 ... according to Annex Il (Section 4) is required. Additional facilities

http://www.purplesurgical.com/uk/wp-content/uploads/2014/11/GB02-58682-Directive-93.42.EEC_.pdf

Date added: June 30, 2015 - Views: 1

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Product Service EC Certificate - GS 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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TÜVRheinland EC Certificate Directive 93/ 42/ EEC ...

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

http://www.instaltm.pl/Certyfikaty%20%5bpdf%5d/EC_en.pdf

Date added: June 30, 2015 - Views: 1