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DIRECTIVE 2007/47/ECOF THEEUR OPEANP ARLIAMENTANDOFTHE COUNCIL of 5September 2007 amending CouncilDirectiv e90/385/EEConthe approximation ofthe lawsof theMemberStates relating toactiv eimplantablemedical devices,CouncilDirective 93/42/EECconcer ningmedical devices andDirectiv e98/8/ECconcerning theplacing ofbiocidalproductson themark et (Textwith EEArelevance)

THE EUROPEANPARLIAMENT ANDTHECOUNCILOF THE

EUROPEANUNION,

Havingregard to theTreatyestablishing theEuropean Commu- nity,and inpar ticularAr ticle95thereof,

Havingrega rdtothe proposalfromtheCommission,

Havingrega rdtotheopinion ofthe EuropeanEconomic and

Social Committee(

1 Actingin accordancewith theprocedure laiddo wnin Article 251 of theT reaty( 2

Whereas:

(1)Council Directive93/42/EEC ( 3 ) requiresthe Commission to submita report totheCouncil,no later thanf iveyears from thedate ofim plementationof thatDirective, concerning:(i) infor mationonincidentsoccurring follo w- ing theplacing ofdevices onthe market,(ii) clinical investigationcar riedoutinaccordancewith theprocedure set outin AnnexVIII toDirective 93/42/EEC,and (iii) design examinationand ECtype examinationof medical devices thatincor porate,asaninteg ralpar t,a substance which,if usedseparately ,ma ybeconsideredto bea medicinal productas definedin Directive2001/83/EC of the EuropeanP arliamentandofthe Councilof 6No vember

2001 onthe Communitycode relatingto medicinal

products forhumanuse ( 4 ) andwhich isliable toact upon the bodywith actionancillar yt othatofthe device. (2)The Commissionbrought for wardtheconclusionsofthat reportin itsCommunication to theCouncil andthe

European Parliamentonmedical deviceswhich, atthe

request ofthe MemberStat es,was expandedtoco verall aspects ofthe Communityregulator yframew orkfor medical devices. (3)This Communicationwas welcomedby theCouncil inits

Conclusions onmedical devicesof 2December 2003(

5 ). Itwas alsodiscussed bythe EuropeanPar liamentwhich on

3 June2003 adopted aresolutiononthe health

implicationsof Directive93/42/EEC ( 6 (4)Followingfrom theconclusions drawnin thatCommu- nication itis necessary andappropriate to amendCouncil

Directive 90/385/EEC(

7 ), Directive93/42/EEC andDirec- tive 98/8/ECof theEuropean Parliamentand ofthe

Council (

8 (5)Toensure consistencyof interpretation andimpl ementation between Directives93/42/EEC and90/385/EEC thelega l frameworkrelat edtoissuessuc has authorised representa- tive, theEuropean databank,health protectionmeasures, and theapplication ofDirective 93/42/EECas regards medical devicesincor poratingstablederivat esof human blood orhuman plasma,as introducedb yDirective 2000/

70/EC (

9 ), shouldbe extended toDirective90/385/EEC. The application ofthe provisions onmedicaldevicesincor por- ating stableder ivatesofhumanblood orhuman plasma includes applicationof Directive2002/98/EC ofthe

European Parliamentandof theCouncil of27 January

2003 settingstandards ofquality andsafet yf orthe

collection, testing,processing,storag eand distributionof human bloodand bloodcomponents andamending

Directive 2001/83/EC(

10 (6)It isnecessar ytoclarify thatsof twareinitso wnr ight,when specificallyintended bythe manufacturer tobe usedforone or moreof themedical purposes setout inthedefinitionof a medicaldevice, isa medicaldevice. Software for general purposeswhen usedin ahealthcare settingis nota medical device. (7)Particularcare shouldbe takent oensure thatthe reprocessing ofmedical devicesdoes notendanger patients' safetyor health.It istheref orenecessar yt oprovide clarificationon thedefi nitionof theterm 'singleuse ', as well ast omakeprovision for uniformlabelling and

21.9.2007ENOfficialJour naloftheEuropean UnionL 247/21

1 ) OJC 195,18.8.2006, p.14. 2 ) Opinionof theEuropean Parliament of29 March2007(notyet published inthe OfficialJour nal)and CouncilDecisionof23 July 2007.
3 ) OJL 169,12.7.1993, p.1. Directiveas lastamended by Regulation (EC) No1882/2003 ofthe EuropeanParliament andof theCouncil (OJ L284, 31.10.2003,p. 1). 4 ) OJL 311,28.11.2001, p.67. Directiveas lastamended by Regulation (EC)No 1901/2006of theEuropean Parliament andof the Council(OJ L378, 27.12.2006,p. 1). 5 ) OJC 20,24.1.2004, p.1. 6 ) OJC 68E, 18.3.2004,p. 85. 7 ) OJL 189,20.7.1990, p.17. Directiveas lastamended byRegulation (EC) No1882/2003. 8 ) OJL 123,24.4.1998, p.1. Directiveas lastamended byCommission

Directive 2007/20/EC(OJ L94, 4.4.2007,p. 23).

9 ) Directive2000/70/EC ofthe EuropeanParliament andof the Council of16 November 2000amendingCouncilDirective 93/42/ EEC asregards medicaldevices incorporating stableder ivatesof human bloodor humanplasma (OJL 313,13.12.2000, p.22). 10 ) OJL 33,8.2.2003, p.30. instructionsf oruse.Moreover ,the Commissionshould engagein further analysisinordert osee ifadditional measures areappropr iatetoensure ahighlevelof protectionf orpatients. (8)In thelight oftec hnicalinno vationandthedevelopment of initiatives atthe international levelitisnecessar yto enhance thepro visionsonclinicalevaluation, including clarificationthat clinicaldata isgenerally requiredf orall devices regardlessofclassific ationand thepossibilityto centralise dataon clinicalin vestigationsin theEuropean databank. (9)In orderto provide clearerevidenceofthe compliance of custom-madedevice manufacturers, anexplicitrequirement fora postmarket productionreview systeminv olving incident reportingto authoritiesshouldbe introduced,asis already inplace for otherdevices,andto enhancepatient information,arequirement shouldbe introducedthat the

Statement

'under AnnexVIII toDirective 93/42/EEC should beav ailabletothepatient andthat itshould contain thename ofthe manufacturer . (10)In thelight ofte chnicalprogress ininformation technology and medicaldevices, aprocess shouldbe provided toallo w informationsuppliedby themanuf acturerto bea vailable by othermeans. (11)Manufacturersof ClassI sterile and/ormeasur ingmedical devices shouldbe giventhe option ofusing thefullquality assurance conformityassessmentmodulein orderto providethem withmore flexibility inthe choiceof compliance modules. (12)In orderto support marketsurveillanceactivities by Member Statesit isnecessar yand appropriate,inthe case of implantabledevices, to increasethetimeper iodf orthe retentionof documentsf oradministrative purposestoat least 15years. (13)For theappropr iateandefficientfunctioningof Directive

93/42/EEC asrega rdsregulatoryadviceon classification

issues arisingatnational level,in particular onwhether or not aproduct falls underthedefinitionof amedical device, it isin theinter estof nationalmarketsurveillance andthe health andsafety ofhumans to establisha procedurefor decisions onwhether ornot aproduct fallsunder the medical devicedefinition. (14)Toensure that,where amanufa cturerdoes nothave a registeredplace ofbusiness inthe Community, authorities have asing leindividualpersonauthor isedby the manufacturerwhom they canaddressinmatt ersrelating to thecompliance ofthe deviceswith theDirectives itis necessaryt ointroduceanoblig ationf orsuch manufacturers to designatean authorised representativefora device.This designation shouldbe effective atleastfor alldevices ofthe same model. (15)Tofur therensurepublichealth andsafet yit isnecessar yto providef oramoreconsistent applicationof thepro visions on healthprotection measures.P articular careshouldbe taken toensure that,when inuse, theproducts donot endanger patients 'health orsafety . (16)In supportoftransparency inCommunity legislation, certaininf ormationrelatedtomedical devicesand their conformitywithDirective 93/42/EEC,in particular infor - mation onregistration, onvigilance reports andon certificates,shouldbea vailablet oany interestedparty and theg eneralpublic. (17)Tobetter coordinate theapplicationandefficiency of national resourceswhen appliedto issuesrelated to Directive 93/42/EEC,the MemberStates shouldcooperate with eachother andat international level. (18)As designf orpatientsafetyinitiatives play anincreasing role inpublic healthpolicy ,it isnecessaryto expresslyset out theneed toconsider ergonomicdesign inthe essential requirements. Inaddition thelevel oftraining andkno wl- edgeof theuser ,suc hasinthe caseofala yuser ,should be furtheremphasised withinthe essentialrequirements. The manufacturershould placepar ticularemphasis onthe consequences ofmisuse ofthe productand itsadverse effects onthe humanbody . (19)In thelight ofexper ienceg ainedregardingactivities ofboth the notifiedbodiesand theauthor itiesin theassessment of devices whichrequire inter ventionoftheappropriate authoritiesf ormedicinesandhuman bloodder ivatives their dutiesand tasksshould beclar ified. (20)Takingaccount ofthe growing impor tanceofsoftware in the fieldofmedical devices,be itas standalone oras softwareincor poratedinadevice, validationof software in accordance withthe state oftheart shouldbe anessential requirement. (21)In thelight ofthe increaseduse ofthird Par tiesto carr yout the designand manufacture ofdevicesonbehalf ofthe manufacturer,itis impor tantthat themanufacturer demonstratesthat heapplies adequatecontrols tothe third partyto continueto ensurethe efficient operatingof the quality system. (22)The classificationr ulesarebasedon thevulnerability ofthe human bodytaking accountof thepot entialr isks associated withthe technic aldesignandmanufactureof the devices.Explicit prior authorisationwithregard to conformity,includinganassessment ofthe design documentation, isrequired for ClassIIIdevicesto be placed onthe market.In perfor mingits dutiesunderthe quality assuranceand verification conformityassessment modules forallother classesof devices,it isessential and necessaryf oranotified body, inorderto beassuredofthe L 247/22ENOfficialJour naloftheEuropean Union21.9.2007 compliance ofthe manufacturer withDirective93/42/EEC, to reviewthe designdocumentation for themedical device. The depthandextent ofthis reviewshould becommensu- ratewith theclassif icationof thedevice,theno veltyof the intended treatment,the degreeof intervention, theno velty of thete chnologyorconstruction mater ials,andthe complexityof thedesign and/ort echnology .This review can beachieved bytaking arepresentative exampleof design documentationof oneor moretype(s) ofdevices from thosebeing manufactured.Fur therreview(s), andin particularthe assessmentof changes to thedesignthat could affectconf ormitywiththeessentialrequirements, should bepar tofthesur veillanceactivities ofthe notified body. (23)It isnecessar ytoremove theincoherence inthe classificationr ulesasaresult ofwhich invasive devices with respectto bodyor ifices intendedforconnectionto an active ClassI medicaldevice werenot classified. (24)The measuresnecessar yforthe implementationof Directive 90/385/EECand Directive93/42/EEC shouldbe adoptedin accordancewith CouncilDecision 1999/468/EC of 28June 1999la yingdo wntheproceduresf orthe exerciseof implementingpo wersconfer redonthe

Commission (

1 (25)In particular,powershould beconferred onthe Commis- sion toadapt classificationrulesf ormedical devices,to adaptthe meansby whichthe infor mationneeded touse medical devicessafel yandproperlyma ybe setout, to determineconditions for makingcertaininf ormation publicly available,toadapt thepro visionson clinical investigationsset outin certain Annexes,to adopt particularrequirements for placingcertainmedical devices on themarket orputting theminto service, andto take decisions towithdraw suchdevices fromthe marketf or reasons ofprot ectionofhealthor safety .Since those measures areof general scopeandaredesigned to amendor supplement Directive90/385/EEC andDirective 93/42/EEC by themodifica tionoradditionof non-essentialelements, they mustbe adopted inaccordancewiththe regulatory procedure withscr utinyprovidedf orinArticle 5aof

Decision 1999/468/EC.

(26)When, onimperative groundsof urgency ,the normaltime limits fortheregulatory procedurewith scrutiny cannotbe compliedwith, theCommission shouldbe ableto usethe urgencyprocedure provided forinAr ticle5a(6)ofDecision

1999/468/EC fortakingdecisions onwithdra walof certain

medical devicesfrom themarket andf orthe adoption of particularrequirements for placingsuchdeviceson the market orputting theminto service for reasonsof protectionof healthor safety. (27)The Commissionshould givea mandatet oCEN and/or Cenelec tospecifyt echnicalrequirements andasuitable specificlabel for phthalate-containingdeviceswithin12 months afterentryinto forceofthis Directive. (28)Many MemberStat eshaveestablishedrecommendations with theaim ofreducing orlimiting theuse ofmedical devices containingcr iticalphthalatesonchildre n,pregnant and nursingwomen andother patientsat risk. To enable medical professionalstoav oidsuc hrisks,devices which possibly releasephthalat estothe bodyofthepatient should be labelledaccording ly. (29)In accordancewith theessential requirementson thedesign and manufactureofmedical devices,manufa cturersshould avoidthe useof substancesthat may possiblycomp romise the healthof patients,in particular ofsubstances whichare carcinogenic,mutagenic orto xicto reproduction,and should, asappropr iate,striveto developalternative substances orproducts witha lower risk potential. (30)It shouldbe clarifi edthatalongsideDirectives90/385/EEC and 93/42/EEC,in vitrodiagnostic medicaldevices, which are thesubject ofDirective 98/79/ECof theEuropean

Parliamentand ofthe Councilof 27Oct ober1998 onin

vitro diagnosticmedical devices( 2 ), shouldalso beexcluded from thescope ofDirective 98/8/EC. (31)In accordancewith point34 ofthe Interinstitutional agreement onbetter law-making ( 3 ), MemberStates are encouraged todrawup, for themselvesand intheinterests of theCommunity ,theirown tablesillustrating, asfaras possible, thecor relationbetweenthisDirective andthe transposition measures,and tomake thempublic. (32)Directives 90/385/EEC,93/42/EEC and98/8/EC should thereforebe amendedaccording ly,

HAVEADOPTED THISDIRECTIVE:

Article1

Directive 90/385/EECis herebyamended asf ollows:

1. Article1shall beamended asf ollows:

(a) paragraph2 shallbe amendedas follo ws: (i) point(a) shallbe replacedby thef ollowing: (a)"medical device"means anyinstr ument, apparatus, appliance,sof tware,materialor other article,whetherused aloneor in combination, togetherwithany accessories, including thesof twareintendedby its

21.9.2007ENOfficialJour naloftheEuropean UnionL 247/23

1 ) OJL 184,17.7.1999, p.23. Decisionas amendedb yDecision 2006/

512/EC (OJL 200,22.7.2006, p.11).

2 ) OJL 331,7.12.1998, p.1. Directiveas lastamended by Regulation (EC) No1882/2003. 3 ) OJC 321,31.12.2003, p.1. manufacturerto beused specificallyf or diagnostic and/ortherapeutic purposes and necessaryf oritsproperapplication, intended bythe manufacturert obe used forhuman beingsf orthe purposeof: - diagnosis, prevention,monit oring, treatment oralleviation ofdisease, - diagnosis, monitoring,treatment,alle- viation ofor compensationf oran injuryor handicap, - investigation,replacement ormodifi - cation ofthe anatomy orofa physiologicalprocess, - control ofconception, and whichdoes notac hieveits principal intended actionin oron thehuman body by pharmacological,immunologicalor metabolic means,but whichma ybe assistedin itsfunction bysuc hmeans; (ii) points(d), (e)and (f)shall bereplaced bythe following: (d)"custom-madedevice "means anydevice specificallymade inaccordance witha duly qualifiedmedical practitioner'swr itten pre- scriptionwhichgives, underhis responsi- bility,specific designcharact eristics andis intended forthesole useof apar ticular patient. Mass-produceddevices whichneed to beadapt edtomeet thespecificrequire- ments ofthe medicalpractitioner orany other professionalusershall notbe con- sidered tobe custom-madedevices; (e)"device intendedfor clinicalinvestigation" means anydeviceintended for useby a duly qualifiedmedical practitionerwhen conducting clinicalinvestig ationsas referredto inSection 2.1of Annex7 in an adequatehuman clinicalenvi ronment.

For thepur poseofconductingclinical

investigation,any otherperson who,by virtueof hisprofessio nalqualif ications,is authorisedto carr youtsuchinvestigation shall beaccept edasequivalentto aduly qualifiedmedical practitioner; (f)"intendedpur pose"means theuse for which thedevice isintende daccording to the datasupplied bythe manufacturer onthe labelling,in theinstr uctionsand/or in promotional material; (iii) thef ollowingpointsshallbeadded: (j)"authorisedrepresentative "means anynat- ural orlega lpersonestablishedin the

Community who,explicitly designatedby

the manufacturer,actsand may be addressed byauthor itiesandbodiesin the

Community insteadof themanufacturer

with regardto thelatter'sobligations under this Directive; (k)"clinical data"means thesafet yand/or performanceinfor mationthatisgenerated from theuse ofa device.Clinical dataare sourced from: - clinical investigation(s)ofthe device concerned,or - clinical investigation(s)orother stu- dies reportedinthescientifi clit era- ture, ofa similardevice for which equivalence tothedevice inquestion can bedemonstrated, or - published and/orunp ublishedreports on otherclinical experience ofeither the devicein questionor asimilar device forwhichequivalence tothe device inquestion canbe demon- strated. (b) paragraph3 shallbe replacedby thef ollowing:

3. Wherean activeimplantable medicaldevice is

intended toadministera substancedefi nedas a medicinal productwithin themeaning ofAr ticle1 of

Directive 2001/83/EC(*), thatdevice shallbe gov-

ernedby thisDirective, withoutprejudice to the provisionsof Directive2001/83/EC withregard to the medicinal product. (*) OJL 311,28.11.2001, p.67. Directiveas last amended byRegulation (EC)No 1901/2006(OJ

L 378,27.12.2006, p.1)

(c) paragraph4 shallbe replacedby thef ollowing:

4. Wherean activeimplantable medicaldevice

incorporates,asan integral part, asubstancewhich, if usedseparately ,maybe consideredtobe amedicinal product withinthe meaningof Article 1of Directive

2001/83/EC andwhich isliable toact uponthe

L 247/24ENOfficialJour naloftheEuropean Union21.9.2007 human bodywith actionthat isancillar yto thatof the device, thatdevice shallbe evaluatedand authorised in accordance withthis Directive.quotesdbs_dbs43.pdfusesText_43

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