DIRECTIVE
2007/47/EC OF
THE EUROPEAN PARLIAMENT AND OF THE COUNCIL ...
DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the ...
http://www.cro-drug-device.com/files/MDD Revision OJ 21Sep07 2007-47-EC.pdf
Implementing
New European Vigilance Procedures
by M Donawa - All 5 versions
http://www.cro-drug-device.com/files/MDT NovDec07 Vigilance.pdf
Transitional period_2007-47-EC_guidance_final
Directive 2007/47/EC was published in the Official Journal of 21 September 2007 and ... Questions relating to the implementation of Directive 2007/47/EC ...
http://ec.europa.eu/enterprise/sectors/medical-devices/files/guide-stds-directives/transitionalperiod_2007-47-ec_guidance_final_en.pdf
2007/47/EC - CE
Marking European Authorized Representative ...
DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the ...
http://www.obelis.net/Library/Directives/files/GPSD-DIRECTIVE.pdf
Directive
2007/47/EC
Modifications to the Medical Devices Directive
Annex X significantly changed. • Centralized data on clinical investigations in EU databank appears to be an EU Commission objective. *Directive 2007/47/EC, ...
http://www.lifesciencesbc.ca/files/Pictures/Issue24/2_-_Directive_200747EC.pdf
CL1993L0042EN0050010.0001.3bi_cp
1..1
Directive 2007/47/EC of the European Parliament and of the Council of. 5 September 2007. L 247. 21. 21.9.2007. 1993L0042 — EN — 11.10.2007 — 005.001 — 1 ...
http://medical.cms.itri.org.tw/pdf/e01.pdf
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 ...
http://www.quality-service.ch/pdf/Flyer_2007_47_EC_Vers01.pdf
2009-4
Guidance on Notified Body's Tasks of Technical ...
The Directive 2007/47/EC, covering the revision of the MDD, ... Following the adoption of Directive 2007/47/EC, from 21 March 2010 at the latest, ...
http://www.nbog.eu/resources/NBOG_BPG_2009_4_EN.pdf
NBOG
meeting
24 Jun 2009 ... the changes by Directive 2007/47/EC and the development of a form for notifications between Member States on certificates suspended or ...
http://www.nbog.eu/resources/NBOG_meeting_June_2009_content1.pdf
Preliminary Draft Proposal for Guidance to Directive
2007/47/EC
...
7 Jul 2009 ... The revised Medical Device Directive 93/42/EEC as amended by Directive 2007/47/EC has included new requirements for medical devices ...
http://www.pvc.dk/billeder/SoftPVC/1A6C01F8F41545AB81E449A71CA2A850.pdf
Preliminary Draft Proposal for Guidance to Directive
2007/47/EC
...
Medical Devices Directive (MDD) 93/42/EEC as amended by Directive 2007/47/EC; the SCENIHR opinion dated Feb 6, 2008 'The safety of medical devices ...
http://echa.europa.eu/doc/about/organisation/msc/msc_rcoms/msc_rcom_annex_15/dhep/dhep_phtalates_guidance.pdf
Template for BT cover pages
of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC ... This mandate relates to Directive 2007/47/EC of the European Parliament ...
http://www.cenelec.eu/NR/rdonlyres/144B7979-77EA-4D7D-93C4-0D116C65E6D3/2387/m432en.pdf
Template for BT cover pages
This mandate relates to Directive 2007/47/EC of the European Parliament ... 2007/47/EC, some categories of medical devices containing phthalates which are ...
http://www.cenelec.eu/NR/rdonlyres/144B7979-77EA-4D7D-93C4-0D116C65E6D3/2386/m433en.pdf
Journal of Medical
Device Regulation
implementing of Amending Directive 2007/47/EC recently [Interpretative ... Certificates issued prior to the application of Directive 2007/47/EC ...
http://qualityfirstint.com/interdoc3.pdf
Journal of Medical
Device Regulation
2007/47/EC is unclear concerning control to be exercised, specifically the BSHR ... Amending Directive 2007/47/EC amending Article 1.3 paragraph 2 Council ...
http://qualityfirstint.com/interdoc2.pdf
2008 No. 2936 CONSUMER PROTECTION The Medical Devices (Amendment
...
- All 38 versions
http://www.england-legislation.hmso.gov.uk/si/si2008/pdf/uksi_20082936_en.pdf
2008 No. 530 FEES AND CHARGES The Medical Devices (Fees Amendments
...
(b) OJ No. L189, 20.7.90, p.17 to which amendments have been made by Council Directive 93/68/EEC, OJ No. L 220,. 30.8.1993, p.1 and Directive 2007/47/EC. ...
http://www.england-legislation.hmso.gov.uk/si/si2008/pdf/uksi_20080530_en.pdf
GUIDE FOR MANUFACUTERES TO IMPLMENT NEW REQUIRMENTS INTRODUCED BY
...
30 Oct 2009 ... Council Directive 93/42/EEC as amended by Council Directive 2007/47/EC requires additional information for single use devices in Annex I, ...
http://www.emki-korhaztechnika.hu/site/conf/upload/EUCOMED_GUIDE_1.pdf
0029_MedInfo_EC-Directive_eu:Layout
1
statement that the requirements of 2007/47/EC are fulfilled. ... Transition to EC Directive 2007/47/EC. TÜV SÜD Product Service GmbH. Med-Info ...
http://www.tuv-sud.jp/infoservice/pdf/200907_medinfo.pdf
歐盟2007/47/EC
指令說明
2007.9 歐盟已正式公佈2007/47/EC,各歐盟會員國亦將於其國家衛生法令中 ... 以上僅將改變略為提出,建議各位可由下列連結下載2007/47/EC 全文作研究,將其對技術 ...
http://www.bsigroup.tw/upload/eNews/No54/2007-47-EC(2).pdf
For:
Review Republic of the Philippines Completion Evaluation ...
EC 2007/47/W.P.3. Note to Evaluation Committee members .... EC 2007/47/W.P.3. 2. US$2.4 million. The IFAD loan was provided on highly concessional terms. ...
http://www.ifad.org/gbdocs/eb/ec/e/47/EC-2007-47-WP-3.pdf
For:
Approval Provisional agenda
EC 2007/47/W.P.1. Note to Evaluation Committee members ... Document EC 2007/47/W.P.2 contains the executive summary of the evaluation. ...
http://www.ifad.org/gbdocs/eb/ec/e/47/EC-2007-47-WP-1.pdf
COMMISSION DIRECTIVE 2007/70/EC
of 29 November 2007 amending ...
30.11.2007. (1) OJ L 123, 24.4.1998, p. 1. Directive as last amended by Directive. 2007/47/EC (OJ L 247, 21.9.2007, p. 21). (2) OJ L 307, 24.11.2003, p. 1. ...
http://www.urpl.gov.pl/biobojcze/akty/Directive_2007-70-EC_en.pdf
DIRECTIVES
30.11.2007. Official Journal of the European Union. L 312/23. (1) OJ L 123, 24.4.1998, p. 1. Directive as last amended by Directive. 2007/47/EC (OJ L 247, ...
http://www.urpl.gov.pl/biobojcze/akty/Directive_2007-69-EC_en.pdf
March 21, 2010: Another Y2K for Technical Writers?
2007/47/EC could potentially cause a rippling bottle neck effect as more than .... Planning (albeit on a much smaller scale) for the worst with 2007/47/EC ...
http://www.argotrans.com/wp-content/uploads/2009/10/whitepaper-medical-device-directive1.pdf
Client information note – MDD - Revision to the Medical Devices
...
21 September 2007as Directive 2007/47/EC. • the new directive amends not only the MDD but also the Active Implantable Medical Devices ...
http://www.lrqa.co.uk/downloads/public/other/CIN _changes to MDD Directive.pdf
CDPC _2009_ 14 Compendium of the Member States comments on the
...
Secondly, Directive 2007/47/EC is only one of the legal acts that provide ... Directive 2007/47/EC of the European Parliament and of the Council of 5 ...
http://www.coe.int/t/e/legal_affairs/legal_co-operation/steering_committees/cdpc/Documents/CDPC Plenary meeting, 12-16 10 2009/CDPC _2009_ 14 Compendium of the Member States comments on the Draft Convention Pharmacrime.pdf
COMMISSION
REGULATION (EC) No 1376/2007 of
23 November 2007 ...
23 Nov 2007 ... (5) OJ L 123, 24.4.1998, p. 1. Directive as last amended by Directive. 2007/47/EC (OJ L 247, 21.9.2007, p. 21). ...
http://faolex.fao.org/docs/pdf/eur75809.pdf
COMMISSION DECISION of 20 December 2007 approving
the pre-export ...
derived products thereof as regards the presence of aflatoxins. (notified under document number C(2007) 6451). (Text with EEA relevance). (2008/47/EC) ...
http://www.fsai.ie/uploadedFiles/Legislation/Legislation_Update/Dec2008_47.pdf
Standards Notes Spring-Summer 2009
Guidance on new directive 2007/47/EC: the Commission issued an interpretative ... among others - the entry into force date of the new directive 2007/47/EC. ...
http://www.trade.gov/td/standards/Standards Notes/EU/Spring-Summer 2009.pdf
8 EC MEDICAL DEVICES DIRECTIVES
Directive 2007/47/EC amends the Active Implantable Medical Devices. Directive 90/385/EC and comes into force on 21 December 2008. One change ...
http://www.mhra.gov.uk/home/groups/es-era/documents/publication/con007512.pdf
MEDICAL DEVICES REGULATIONS 2002: REGULATIONS 19 and 30 FORM
RG2
EU market. Article 1. 11 of Directive 2007/47/EC amends Article 10 of Directive. 90/385/EC to include a requirement for manufacturers of custom made active ...
http://www.mhra.gov.uk/home/groups/es-era/documents/publication/con007514.pdf
(N) Nemko
by Directive 2007/47/EC, with the exemption of section 4. This certificate amends EU0803406 issued 2008-10-10. 2006-09-15. 2011-12-01. Nemko EC notification ...
http://www.arizant.com/arizant/pdf/Blankets CE Certificate - EU0803406 (04-23-09).pdf
ce
Directive 2007/47/EC Concerning Medical Devices. (Including standards required to prove compliance to the Essential Requirements) ...
http://www.arizant.com/arizant/pdf/Blankets - EC Declaration-M3.pdf
EU LEGISLATION MAKING USE OF VOLUNTARY STANDARDS
Directive 2007/47/EC;. OJ L 247, 21.09.2007; p. 21-55. Appliances burning gaseous fuels : Council Directive 90/396/EEC of 29 June 1990 on the approximation ...
http://ts.nist.gov/Standards/Global/upload/THE-USE-OF-VOLUNTARY-STANDARDS-IN-SUPPORT-OF-EU-LEGISLATION-Annex-1.pdf
2009
No. 383 FEES AND CHARGES The Medical Devices (Fees Amendments
...
(b) OJ No. L189, 20.7.90, p.17 to which amendments have been made by Council Directive 93/68/EEC, OJ No. L220,. 30.8.1993, p.1 and Directive 2007/47/EC. ...
http://www.opsi.gov.uk/si/si2009/pdf/uksi_20090383_en.pdf
NORMAPME
Newsletter
(Directive 2007/47/EC) Health- care very often occurs in an SME environment and even in a local environment, that it be in clin- ...
http://www.normapme.com/newslet/2009/english/nl_may_09_en.pdf
Navigating the New EU Rules for Medical Device Software
Recital 6 of Directive 2007/47/EC provides that software is a medical device if ... latter part of the definition of medical device in Directive 2007/47/EC: ...
http://www.gtlaw.nl/Upload/Publicaties/633759966118063750-Navigating the New EU Rules for Medical Device Software.pdf
Packaging
Compliance for Medical Devices & IVDs
amending directive 2007/47/EC. • Focusing on issues still under discussion among ... Reuse warning statement requirement per Revision 2007/47/EC ...
http://www.michor-consulting.eu/labelling_conference.pdf
New European Guidance on Borderline Products
by Directive 2007/47/EC, which amends the MDD and the. AIMDD. The amendments come into force on 21 March 2010. Nonexhaustive list of examples ...
http://www.donawa.com/donawa/files/MDT Sept09 EU Borderline Products.pdf
Clinical
Studies in Italy
by M Donawa - 2009Directive 2007/47/EC of the European Parliament and. ➔. First published in Medical Device Technology, 20, 7. (November/December 2009).
http://www.donawa.com/donawa/files/MDT nov_dec_Ital Clin.pdf
ARGMD -
Differences between the Australian and European Union ...
: Directive 2007/47/EC introduces the requirement that manufacturing ...
http://www.tga.gov.au/devices/argmd-drdifferences.pdf
091119 EMIG INFORMATION ON PLACING OT MARKET AND PUTTING INTO
SERVICE
by Directive 2007/47/EC. 2. Medical devices that have been lawfully placed on the market before 21 March 2010 can continue to be used and also be put into ...
http://www.spectaris.de/uploads/tx_ewscontent_pi1/Joint_EU_Medical_Devices_Industry_INFORMATION_ON_PLACING__ON_MARKET_AND_PUTTING_INTO_SERVICE.pdf
Microsoft PowerPoint - Lavin Medical Devices PMA Process
17Sep09
text of Directive 2007/47/EC which amends the Directives on: – Medical Devices ... The changes introduced by the new Directive 2007/47/EC still need ...
http://www.averionintl.com/uploadedFiles/Lavin Medical Devices PMA Process 17Sep09.pdf
Exemption from authorisation for the use of DEHP in medical ...
28 Apr 2009 ... 1Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the ...
http://www.cocir.org/uploads/documents/-36-exemption_from_authorisation_for_the_use_of_dehp_in_medical_devices_final.pdf
COCIR Position Paper Overlap between Medical Device Directive (MDD
...
The amendment of the Medical Device Directive 93/42/EEC by the Directive 2007/47/EC introduces in article 3 additional requirements for medical devices that ...
http://www.cocir.org/uploads/documents/-25-cocir_position_paper__overlap_between_mdd_and_md_11_dec_.pdf
BSI Public Group Training 2009
Medical Device Risk Management. 2. 10. Medical Design and ( Development) Control. 1. 11. MDD 2007/47/EC. Update EU Directive Medical Device (2007/47) ...
http://www.bsithailand.com/download/BSI Public & Group Training 2009.pdf
How to obtain
CE-marking for a medical device
The applicable EU Directive 2007/47/EC / 93/42/EEC foresees three different classification categories for medical devices according to the potential risk ...
http://www.mdi-europa.com/pdf/How to obtain CE.pdf
Medical
Device One‐Day Seminar In Two Sessions
Directive 2007/47/EC take full effect on. 21 March 2010, but manufacturers should ... How will Directive 2007/47/EC affect you? Topics will include: ...
http://www.bioalps.ch/bioalps/en/Internet/Documents/2727.pdf
Folie 1
2007/47/EC (Amending directive for AIMD, MDD, Biocides. Directives) ..... 2007/47/EC are fulfilled in addition if compliance can be demonstrated. ...
http://www.tuvps.co.uk/uploads/images/1261059552513911860097/Webinar_Changes to the Medical Devices Directive.pdf
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