Más lena húsáid in imscrúduithe cliniciúla a beartaíodh an fheiste, beidh na focail “le haghaidh imscrúduithe cliniciúla amháin” uirthi,
if the device is intended for clinical investigations, the words ‘exclusively for clinical investigations’,
Ba cheart na rialacha maidir le himscrúduithe cliniciúla a bheith i gcomhréir leis an treoir idirnáisiúnta sheanbhunaithe sa réimse sin, amhail Caighdeán Idirnáisiúnta ISO 14155:2011 maidir le dea-chleachtas cliniciúil i gcás imscrúduithe cliniciúla ar fheistí leighis lena n-úsáid ag daoine, le gur fusa a bheidh sé lasmuigh den Aontas glacadh leis na torthaí ó imscrúduithe cliniciúla a dhéantar san Aontas mar dhoiciméadacht agus le gur fusa a bheidh sé laistigh den Aontas glacadh leis na torthaí ó imscrúduithe cliniciúla a dhéantar lasmuigh den Aontas i gcomhréir le treoirlínte idirnáisiúnta.
The rules on clinical investigations should be in line with well-established international guidance in this field, such as the international standard ISO 14155:2011 on good clinical practice for clinical investigations of medical devices for human subjects, so as to make it easier for the results of clinical investigations conducted in the Union to be accepted as documentation outside the Union and to make it easier for the results of clinical investigations conducted outside the Union in accordance with international guidelines to be accepted within the Union.
Ba cheart do na hurraitheoirí tarluithe díobhálacha áirithe agus easpaí ar fheistí a tharlaíonn le linn imscrúduithe cliniciúla a thuairisciú do na Ballstáit ina bhfuil na himscrúduithe cliniciúla sin á ndéanamh.
Sponsors should report certain adverse events and device deficiencies that occur during clinical investigations to the Member States in which those clinical investigations are being conducted.
an córas leictreonach maidir le himscrúduithe cliniciúla dá dtagraítear in Airteagal 73;
the electronic system on clinical investigations referred to in Article 73;
MEASTÓIREACHT CHLINICIÚIL AGUS IMSCRÚDUITHE CLINICIÚLA
CLINICAL EVALUATION AND CLINICAL INVESTIGATIONS
Ina theannta sin, ní gá imscrúduithe cliniciúla a dhéanamh sna cásanna dá dtagraítear i mír 6.
In addition, clinical investigations need not be performed in the cases referred to in paragraph 6.
Ceanglais ghinearálta maidir le himscrúduithe cliniciúla a dhéantar chun comhréireacht feistí a léiriú
General requirements regarding clinical investigations conducted to demonstrate conformity of devices
Beidh imscrúduithe cliniciúla faoi réir athbhreithniú eolaíoch agus eiticiúil.
Clinical investigations shall be subject to scientific and ethical review.
nádúr, cuspóirí, rioscaí agus míchaoithiúlachtaí na n-imscrúduithe cliniciúla;
the nature, objectives, benefits, implications, risks and inconveniences of the clinical investigations;
Imscrúduithe cliniciúla ar ábhair éagumasaithe
Clinical investigations on incapacitated subjects
Imscrúduithe cliniciúla ar mhionaoisigh
Clinical investigations on minors
Imscrúduithe cliniciúla ar mhná torracha nó ar mhná atá ag cothú linbh ar an gcíoch
Clinical investigations on pregnant or breastfeeding women
Imscrúduithe cliniciúla i gcásanna éigeandála
Clinical investigations in emergency situations
Iarratas ar imscrúduithe cliniciúla
Application for clinical investigations
Córas leictreonach maidir le himscrúduithe cliniciúla
Electronic system on clinical investigations
chun na huimhreacha aitheantais aonair a chruthú le haghaidh imscrúduithe cliniciúla dá dtagraítear in Airteagal 70(1);
to create the single identification numbers for clinical investigations referred to in Article 70(1);
Imscrúduithe cliniciúla maidir le feistí a bhfuil an mharcáil CE orthu
Clinical investigations regarding devices bearing the CE marking
Modhnuithe substaintiúla ar imscrúduithe cliniciúla
Substantial modifications to clinical investigations
Nós imeachta comhordaithe measúnaithe le haghaidh imscrúduithe cliniciúla
Coordinated assessment procedure for clinical investigations
Tarluithe díobhálacha a tharlaíonn i rith imscrúduithe cliniciúla a thaifeadadh agus a thuairisciú
Recording and reporting of adverse events that occur during clinical investigations
Ceanglais maidir le himscrúduithe cliniciúla eile
Requirements regarding other clinical investigations
imscrúduithe cliniciúla,
clinical investigations,
XV Imscrúduithe cliniciúla
XV Clinical investigations
na húdair atá ann maidir le gan imscrúduithe cliniciúla ná MLFI a dhéanamh.
justifications in relation to non-performance of clinical investigations or PMCF.
taithí a fuarthas in athbhreithnithe ar an meastóireacht chliniciúil, lena n-áirítear torthaí imscrúduithe cliniciúla agus MLCI,
experience from reviews of the clinical evaluation, including the results of any clinical investigations and PMCF,
taithí ó imscrúduithe cliniciúla ar fheistí inchomparáide.
experience from clinical investigations with comparable devices.
IMSCRÚDUITHE CLINICIÚLA
CLINICAL INVESTIGATIONS
imscrúduithe cliniciúla agus staidéir feidhmíochta
clinical investigations and performance studies,
Ba cheart na himscrúduithe cliniciúla sin a bheartaítear le fianaise chliniciúil a bhailiú chun comhréireacht na bhfeistí a thaispeáint a chumhdach leis an Rialachán seo, agus ba cheart, freisin, ceanglais bhunúsacha a leagan síos maidir le measúnuithe eiticiúla agus eolaíocha do chineáil eile imscrúduithe cliniciúla ar fheistí leighis.
This Regulation should cover clinical investigations intended to gather clinical evidence for the purpose of demonstrating conformity of devices and should also lay down basic requirements regarding ethical and scientific assessments for other types of clinical investigations of medical devices.
le go bhféadfar an pobal a chur ar an eolas go leordhóthanach maidir le himscrúduithe cliniciúla agus le go mbeidh urraitheoirí imscrúduithe cliniciúla in ann oibleagáidí faoi Airteagal 62 go hAirteagal 80, faoi Airteagal 82 agus faoi aon ghníomhartha a ghlacfar de bhun Airteagal 81 a chomhlíonadh;
to enable the public to be adequately informed about clinical investigations and to enable sponsors of clinical investigations to comply with obligations under Articles 62 to 80, Article 82, and any acts adopted pursuant to Article 81;
Déanfar imscrúduithe cliniciúla ar bhonn plean iomchuí imscrúdaithe ina léireofar an saineolas eolaíoch agus teicniúil is déanaí agus sonrófar na himscrúduithe sa dóigh is go ndeimhneoidh nó go ndiúltóidh siad éilimh an mhonaróra maidir le sábháilteacht na feiste, a feidhmíocht agus na gnéithe sin a bhaineann le tairbhe-riosca na bhfeistí amhail dá dtagraítear in Airteagal 62(1); áireofar sna himscrúduithe cliniciúla dóthain breathnuithe chun bailíocht eolaíoch na gconclúidí a ráthú.
Clinical investigations shall be performed on the basis of an appropriate plan of investigation reflecting the latest scientific and technical knowledge and defined in such a way as to confirm or refute the manufacturer's claims regarding the safety, performance and aspects relating to benefit-risk of devices as referred to in Article 62(1); the clinical investigations shall include an adequate number of observations to guarantee the scientific validity of the conclusions.
Ós rud é nach féidir go ginearálta coibhéis a léiriú idir feiste leighis agus táirge nár beartaíodh críoch leighis dó, i gcás ina mbaineann na torthaí uile atá ar fáil maidir le himscrúduithe cliniciúla le feistí leighis amháin, ba cheart imscrúduithe cliniciúla a dhéanamh ar tháirgí nár beartaíodh críoch leighis dóibh.
As in general it is not possible to demonstrate equivalence between a medical device and a product without an intended medical purpose, where all available results on clinical investigations relate to medical devices only, clinical investigations should be performed for products without an intended medical purpose.
I gcás ina ndéantar imscrúduithe cliniciúla chun comhréireacht leis na ceanglais ghinearálta ábhartha maidir le sábháilteacht agus feidhmiú a dheimhniú, ní féidir na himscrúduithe cliniciúla agus an measúnú comhréireachta a chur i gcrích laistigh de 6 mhí.
Where clinical investigations are performed to confirm the conformity with the relevant general safety and performance requirements, it is not possible to complete the clinical investigations and the conformity assessment within six months.
Ós rud é gurb é is cuspóir leis na socruithe idirthréimhseacha a chur i bhfeidhm go leor ama a thabhairt do na monaróirí chun na himscrúduithe cliniciúla agus na nósanna imeachta um measúnú comhréireachta atá ina gceangal a dhéanamh, ba cheart críoch a chur leis na socruithe idirthréimhseacha i gcás nach leanann na monaróirí ar aghaidh leis na himscrúduithe cliniciúla nó leis an nós imeachta um measúnú comhréireachta, de réir mar is infheidhme, laistigh de thráthchlár réasúnta.
As the purpose of putting in place the transitional arrangements is to allow the manufacturers enough time to conduct the required clinical investigations and conformity assessment procedures, the transitional arrangements should cease where manufacturers do not proceed with the clinical investigations or conformity assessment procedure, as applicable, within a reasonable timeframe.
Tá feidhm ag an Rialachán seo freisin maidir le himscrúduithe cliniciúla a dhéantar san Aontas agus a bhaineann le feistí leighis agus gabhálais den sórt sin.
This Regulation also applies to clinical investigations concerning such medical devices and accessories conducted in the Union.
Tá feidhm ag an Rialachán seo freisin maidir le himscrúduithe cliniciúla a dhéantar san Aontas a bhaineann leis na táirgí dá dtagraítear sa chéad fhomhír.
This Regulation also applies to clinical investigations conducted in the Union concerning the products referred to in the first subparagraph.
I gcás feistí so-ionchlannaithe agus feistí in aicme III, déanfar imscrúduithe cliniciúla ach amháin más rud é:
In the case of implantable devices and class III devices, clinical investigations shall be performed, except if:
Maidir leis an gceanglas i ndáil le himscrúduithe cliniciúla a dhéanamh de bhun mhír 4, ní bheidh feidhm aige maidir le feistí so-ionchlannaithe ná le feistí aicme III:
The requirement to perform clinical investigations pursuant to paragraph 4 shall not apply to implantable devices and class III devices:
Déanfar imscrúduithe cliniciúla do na táirgí sin ach amháin má bhíonn bonn cirt cuí leis brath ar na sonraí cliniciúla atá ann cheana ó fheiste leighisatá ar aon dul léi.
Clinical investigations shall be performed for those products unless reliance on existing clinical data from an analogous medical device is duly justified.
na coinníollacha faoina ndéanfar na himscrúduithe cliniciúla, lena n-áirítear fad ama measta rannpháirtíochta an ábhair san imscrúdú cliniciúil; agus
the conditions under which the clinical investigations is to be conducted, including the expected duration of the subject's participation in the clinical investigation; and
Déanfaidh na Ballstáit iniúchadh, ar leibhéal iomchuí, ar láithreán nó láithreáin imscrúdaithe le seiceáil go bhfuil na himscrúduithe cliniciúla á ndéanamh i gcomhréir le ceanglais an Rialacháin seo agus leis an bplean formheasta don imscrúdú.
Member States shall inspect, at an appropriate level, investigation site(s) to check that clinical investigations are conducted in accordance with the requirements of this Regulation and with the approved investigation plan.
Leis na treoirlínte sin, féadfar leas a bhaint, mar bhunús, as treoirlínte atá ann cheana, agus iad a oiriúnú, nuair is féidir, chun sonraí loma a roinnt i réimse na n-imscrúduithe cliniciúla.
Those guidelines may take as a basis and adapt, where possible, existing guidelines for sharing of raw data in the field of clinical investigations.
foirmeacha leictreonacha comhchuibhithe maidir le hiarratas a dhéanamh ar imscrúduithe cliniciúla agus measúnú a dhéanamh orthu amhail dá dtagraítear in Airteagal 70 agus Airteagal 78, agus catagóirí nó grúpaí feistí sonracha á n-áireamh;
harmonised electronic forms for the application for clinical investigations and their assessment as referred to in Articles 70 and 78, taking into account specific categories or groups of devices;
aon sonraí cliniciúla nua nó breise is gá le díriú ar shaincheisteanna gan réiteach a ghiniúint, trí imscrúduithe cliniciúla arna ndearadh go cuí i gcomhréir leis an bplean d'fhorbairt chliniciúil; agus
generate, through properly designed clinical investigations in accordance with the clinical development plan, any new or additional clinical data necessary to address outstanding issues; and
Beidh na himscrúduithe cliniciúla i gcomhréir leis an bplean meastóireachta cliniciúla amhail dá dtagraítear i gCuid A d'Iarscríbhinn XIV.
Clinical investigations shall be in line with the clinical evaluation plan as referred to in Part A of Annex XIV.
Ina theannta sin, ba cheart do Eudamed eolas leordhóthanach a sholáthar don phobal maidir le feistí leighis a chuirtear ar an margadh, leis na deimhnithe a ghabhann leo arna n-eisiúint ag comhlachtaí dá dtugtar fógra, leis na hoibreoirí eacnamaíocha ábhartha agus leis na himscrúduithe cliniciúla.
In addition, Eudamed should provide the public with adequate information about devices placed on the market, the corresponding certificates issued by notified bodies, the relevant economic operators and clinical investigations.
Áirítear ar staidéir chliniciúla trialacha cliniciúla ar tháirgí íocshláinte, imscrúduithe cliniciúla is gá le haghaidh meastóireacht chliniciúil ar fheistí leighis agus staidéir feidhmíochta is gá chun meastóireachtaí feidhmíochta a dhéanamh ar fheistí leighis diagnóiseacha in vitro.
Clinical studies comprise clinical trials of medicinal products, clinical investigations required for the clinical evaluation of medical devices and performance studies required for performance evaluations of in vitro diagnostic medical devices.
Chomh maith leis sin, i gcás na dtáirgí sin, ní féidir leis an monaróir imscrúduithe cliniciúla agus an measúnú comhréireachta a chríochnú laistigh de 6 mhí.
Also for those products, it is not possible for the manufacturer to complete clinical investigations and the conformity assessment within 6 months.
- ní mór forbairt bonneagar Teicneolaíochta Faisnéise (TF) nua-aimseartha do bhunachar sonraí lárnach a bheidh ar fáil go poiblí a shaothrú tuilleadh d’fhonn faisnéis lárnach a chur ar fáil maidir le feistí leighis, le hoibreoirí eacnamaíocha ábhartha, le teastais, le himscrúduithe cliniciúla agus le gníomhartha ceartaitheacha um shábháilteacht allamuigh.
- the development of a modern IT infrastructure for a central and publicly available database must be further pursued with a view to providing key information about medical devices, relevant economic operators, certificates, clinical investigations and field safety corrective actions.
Maidir le hAirteagal 168(4)(c) CFAE, socraítear sa Rialachán seo ardchaighdeáin cháilíochta agus sábháilteachta d'fheistí leighis trína áirithiú, maille le nithe eile, go mbeidh na sonraí a ghinfear in imscrúduithe cliniciúla iontaofa agus láidir agus go gcosnófar sábháilteacht na n-ábhar d'imscrúdú cliniciúil.
As regards Article 168(4)(c) TFEU, this Regulation sets high standards of quality and safety for medical devices by ensuring, among other things, that data generated in clinical investigations are reliable and robust and that the safety of the subjects participating in a clinical investigation is protected.