natgillin/translations-raw huggingface dataset:
Such studies are being done by competent authorities and reference laboratories in Member States.
Take študije izvajajo pristojni organi in referenčni laboratoriji v državah članicah.
They are also obliged to identify the target population.
Prav tako morajo opredeliti ciljno populacijo.
Supporting research and innovation and coordinating European and global research efforts.
podpiranje raziskav in inovacij ter usklajevanje evropskih in globalnih raziskovalnih prizadevanj.
Availability also varies over time depending on, for example, logistic factors in manufacturing and distribution.
Poleg tega se razpoložljivost spreminja skozi čas, kar je odvisno na primer od logističnih dejavnikov pri proizvodnji in distribuciji.
The Commission has already taken the following steps as regards market access and performance of devices:
Komisija je že sprejela naslednje ukrepe v zvezi z dostopom do trga in učinkovitostjo pripomočkov:
This depends on the one hand on the individual's immune system and on the other hand on the sensitivity of the technique employed (5) .
To je po eni strani odvisno od imunskega sistema posameznika, po drugi strani pa od občutljivosti uporabljene tehnike (5) .
In order to place these tests on the EU market, the manufacturer has to comply with the relevant provisions of the Directive.
Da bi se ti testi dali na trg EU, mora proizvajalec upoštevati ustrezne določbe Direktive.
This is because the manufacturer may destine them for non-EU markets or there may not be distributors selling these devices in all Member States.
To gre pripisati dejstvu, da jih proizvajalec lahko nameni za trge zunaj EU ali pa ni distributerjev, ki bi te pripomočke prodajali v vseh državah članicah.
Nevertheless, it is important to keep in mind that the field is evolving rapidly and the body of literature is developing.
Kljub temu je pomembno upoštevati, da se to področje hitro razvija in se literarni članki hitro objavljajo.
However, the device may not fall behind what can reasonably be achieved and is achieved by a majority of devices (13) .
Vendar pa pripomoček ne sme zaostajati pri tem, kar je mogoče razumno doseči in ga doseže večina pripomočkov (13) .
The instructions for use must also contain the levels of performance for the parameters above (11) .
Navodila za uporabo morajo vsebovati tudi ravni učinkovitosti za zgoraj navedene parametre (11) .
The data should originate from studies in a clinical or other appropriate environment or result from relevant references (12) .
Podatki bi morali izhajati iz študij v kliničnem ali drugem ustreznem okolju ali iz ustreznih referenc (12) .
Such practices are generally covered by national legislation, which can vary significantly between Member States.
Take prakse so običajno zajete v nacionalni zakonodaji, ki se lahko med državami članicami zelo razlikuje.
The Commission will continue facilitating maximum collaboration of regulators, also at international level, to detect and remove such devices from the market.
Komisija bo še naprej spodbujala čim večje sodelovanje regulativnih organov, tudi na mednarodni ravni, pri odkrivanju in odstranjevanju takih pripomočkov s trga.
It is recommended that the competent authorities cooperate also with importers and in particular distributors, both of whom can help to identify trade with counterfeit devices.
Priporoča se, da pristojni organi sodelujejo tudi z uvozniki in zlasti z distributerji, saj oboji lahko pomagajo pri odkrivanju trgovine s ponarejenimi pripomočki;
If appropriate, the Medical Device Coordination Group will issue corresponding guidance.
Po potrebi bo Koordinacijska skupina za medicinske pripomočke izdala ustrezne smernice;
Member States should show solidarity in making arrangements for the fair distribution of available stocks and laboratory equipment to where they are most needed.
države članice bi morale izkazati solidarnost in sprejeti ukrepe za pravično distribucijo razpoložljivih zalog in laboratorijske opreme na območja, kjer je to najbolj potrebno.
Wider testing is urgently needed for successful pandemic control.
Za uspešen nadzor pandemije je nujno potrebno širše testiranje.
Coordination of national strategies will be indispensable for this and further guidance should be provided in the context of the exit strategy currently in development by the Commission and Member States.
Za to bo nujno usklajevanje nacionalnih strategij, zagotoviti pa bi bilo treba nadaljnje smernice v okviru izhodne strategije, ki jo trenutno razvijajo Komisija in države članice.
It is therefore important that the mutation profile of the virus is monitored and that on that basis a particular RT-PCR approach is used.
Zato je pomembno spremljati mutacije virusa in na tej podlagi uporabiti specifičen pristop RT-PCR.
"State of the art" does not mean that the device has to be the best in its class.
Najsodobnejše ne pomeni, da mora biti pripomoček najboljši v svojem razredu.
The information on establishment of performance should be complete to allow an assessment of its quality.
Informacije o določitvi učinkovitosti bi morale biti popolne, da se omogoči ocena njihove kakovosti.
Antigen tests could also in principle be used for diagnosis but not many of those have so far been developed.
Za diagnosticiranje bi se lahko načeloma uporabljali tudi antigenski testi, vendar jih še ni veliko razvitih.
The intended purpose must be specified in the instructions for use and/or on the label, unless it is obvious to the user (10) .
Predvideni namen mora biti naveden v navodilih za uporabo in/ali na oznaki, razen če je uporabniku (10) jasen.
Another issue currently is the lack of publicly available comparator data, which makes it difficult to compare the performance of devices.
Dodatna težava je trenutno pomanjkanje javno dostopnih primerjalnih podatkov, zaradi česar je težko primerjati učinkovitost pripomočkov.
However, the Regulation already provides for a transitional period starting on the date of its entry into force (May 2017) during which the conformity of in vitro diagnostic medical devices can be assessed either under the Regulation or under the Directive.
Vendar Uredba že določa prehodno obdobje, ki se začne z datumom začetka njene veljavnosti (maj 2017) in v katerem se skladnost in vitro diagnostičnih medicinskih pripomočkov lahko ugotavlja na podlagi Uredbe ali Direktive.
Seroconversion panels and positive sample panels are examples of further materials that are needed.
Plošče za serokonverzijo in pozitivne vzorčne plošče so primeri nadaljnjih potrebnih materialov.
The Commission will coordinate the work of the network and will provide the necessary analytical support to the Member States in the management and mitigation of the crisis.
Komisija bo usklajevala delo mreže in državam članicam zagotavljala potrebno analitično podporo pri obvladovanju in blažitvi kriznih razmer;
It should be noted that the availability varies widely between Member States.
Opozoriti je treba, da se razpoložljivost testov zelo razlikuje med državami članicami.
Validation refers to confirmation that the test achieves the performance levels specified by the manufacturer.
Validacija se nanaša na potrditev, da test dosega ravni učinkovitosti, ki jih je navedel proizvajalec.
It is also important to take account of the features of the population in which the test is intended to be used, for example whether the prevalence of infection is expected to be low or high, or whether there are local virus variants.
Upoštevati je treba tudi značilnosti populacije, pri kateri naj bi se test uporabljal, na primer ali se pričakuje, da bo prevalenca okužbe nizka ali visoka, in ali obstajajo lokalne različice virusa.
From 26 May 2022, the Directive will be replaced by Regulation (EU) 2017/746 on in vitro diagnostic medical devices (2) .
Direktiva bo od 26. maja 2022 nadomeščena z Uredbo (EU) 2017/746 o in vitro diagnostičnih medicinskih pripomočkih (2) .
Exceptionally, in the interest of protection of health, the Directive states that a Member State may, in response to a duly justified request, authorise the placing on the market within its territory of individual devices for which the applicable conformity assessment procedures have not been carried out yet (e.g. pending the completion of the device's evaluation).
V Direktivi je v interesu varovanja zdravja izjemoma navedeno, da lahko država članica v odgovor na ustrezno utemeljeno zahtevo dovoli na svojem ozemlju dajanje na trg posameznih pripomočkov, za katere še niso bili opravljeni veljavni postopki ugotavljanja skladnosti (npr. dokler ni zaključena ocena pripomočka).
It is clear that in the case of COVID-19 the state of the art is evolving rapidly.
Jasno je, da se pri COVID-19 najsodobnejše hitro razvija.
This should be complete and precise, including the intended user and clinical aspects such as the target population.
Ta bi moral biti naveden v celoti in natančno, vključno s predvidenim uporabnikom in kliničnimi vidiki, kot je ciljna populacija.
Antigen tests are found in rapid test form (some of them include readers to help interpret the result).
Antigenski testi so hitri testi (nekateri vključujejo čitalnike, ki so v pomoč pri razlagi rezultata).
Production of sufficient volumes of tests will require enhanced cooperation between companies, which should be done in accordance with the Temporary Framework for assessing antitrust issues related to business cooperation (25) .
za proizvodnjo zadostnega števila testov bo potrebno okrepljeno sodelovanje med podjetji, ki bi moralo biti v skladu z začasnim okvirom za ocenjevanje protimonopolnih vprašanj, povezanih s poslovnim sodelovanjem (25) ;
The Commission in cooperation with Member States will facilitate the placing on the market of safe and reliable test devices.
Komisija bo v sodelovanju z državami članicami olajšala dajanje na trg varnih in zanesljivih pripomočkov za testiranje.
A number of counterfeit devices have been identified by national competent authorities that have been placed on the market illegally, for example with falsified proof of national registration, falsified notified body certificate or missing regulatory documentation.
pristojni nacionalni organi so odkrili številne ponarejene pripomočke, ki so bili dani na trg nezakonito, na primer s ponarejenim potrdilom o nacionalni registraciji, ponarejenim certifikatom priglašenega organa ali manjkajočo regulativno dokumentacijo.
Overview of tests and their purposes
Pregled testov in njihovih namenov
There are obvious benefits of sharing the results of those validations and organising centralised validation studies to make the most efficient use of resources.
Obstajajo očitne koristi izmenjave rezultatov navedenih validacij in organizacije centraliziranih študij za validacijo, da se zagotovi najučinkovitejša raba virov.
Scarcity of reference methods and materials poses difficulties for these validation studies, and also for the evaluation of device performance by manufacturers.
Pomanjkanje referenčnih metod in materialov pomeni težave za te študije za validacijo in tudi za oceno učinkovitosti pripomočkov s strani proizvajalcev.
For example, in the control stage it may be particularly important to identify positive cases with a high level of specificity (i.e. distinguishing COVID-19 from other similar but less dangerous diseases) to avoid unnecessary burden on the healthcare system.
V fazi nadzora je lahko na primer zlasti pomembno opredeliti pozitivne primere z visoko stopnjo specifičnosti (tj. razlikovanje med COVID-19 in drugimi podobnimi, vendar manj nevarnimi boleznimi), da se prepreči nepotrebno breme za zdravstveni sistem.
Also, if a test is easy to use and cheap but has a relatively low specificity, this can be overcome by repeating the test two or even three times.
Če pa je test enostaven za uporabo in je poceni, vendar ima relativno nizko specifičnost, se ta lahko odpravi z dvakratno ali celo trikratno ponovitvijo.
This is particularly important in the context of assessing the effect of public health countermeasures and designing safe de-escalation strategies.
To je zlasti pomembno pri ocenjevanju učinka protiukrepov na področju javnega zdravja in oblikovanju varnih strategij za postopno opuščanje ukrepov.
However, especially given the rapid development of the pandemic, the performance of the device may vary in practice in comparison to the performance study the manufacturer has done for the purposes of CE-marking.
Vendar se lahko predvsem zaradi hitrega razvoja pandemije učinkovitost pripomočka v praksi razlikuje od tiste iz študije učinkovitosti, ki jo je proizvajalec opravil za namene pridobitve oznake CE.
They are also termed serological tests as they are typically performed on blood serum.
Imenujejo se tudi serološki testi, saj se z njimi običajno testira krvni serum.
Facilitating continuous exchange of information between competent authorities for in vitro diagnostics in the framework of the dedicated subgroup of the Medical Device Coordination Group (18) .
spodbujanje neprekinjene izmenjave informacij med organi, pristojnimi za in vitro diagnostiko, v okviru namenske podskupine Koordinacijske skupine za medicinske pripomočke (18) .
With every new patient infected, the virus may change (mutate) and these mutations in turn may render a particular test less effective, or even ineffective.
Pri vsakem novem okuženem bolniku lahko virus mutira, zaradi teh mutacij pa lahko določen test postane manj učinkovit ali celo neučinkovit.
A notified body will assess the technical documentation of such tests including design and usability and will issue a certificate (14) .
Priglašeni organ bo ocenil tehnično dokumentacijo takih testov, vključno z njihovo zasnovo in uporabnostjo, ter izdal certifikat (14) .
For example, manufacturers should clearly identify comparator methods, how many subjects were part of the performance study, how those subjects were qualified as positive or negative.
Proizvajalci morajo na primer jasno opredeliti primerjalne metode ter koliko udeležencev je bilo vključenih v študijo učinkovitosti in kako so bili ti udeleženci opredeljeni kot pozitivni ali negativni.
Devices intended for self-testing require the involvement of a notified body which must carry out additional verification of the technical documentation.
Pri pripomočkih, namenjenih samotestiranju, je treba vključiti priglašeni organ, ki mora opraviti dodatno preverjanje tehnične dokumentacije.
Finally, good performance of self-tests is particularly important as those are destined to the lay user.
Nazadnje, dobra učinkovitost samotestov je še posebej pomembna, saj so ti testi namenjeni nestrokovnim uporabnikom.
The Commission will facilitate the discussion of national testing strategies in the coming weeks to foster a common EU approach, as far as this is appropriate.
Komisija bo v prihodnjih tednih spodbujala razpravo o nacionalnih strategijah testiranja, da bi se čim prej oblikoval najboljši možni skupni pristop EU.
Several special research and innovation actions have been launched in 2020, addressing, among other topics, the development of COVID-19 diagnostics, treatments and vaccines, as well as the infrastructures and resources that enable this research.
V letu 2020 se je začelo izvajati več posebnih ukrepov na področju raziskav in inovacij, ki med drugim obravnavajo razvoj diagnostike, zdravljenj in cepiv za COVID-19 ter infrastrukture in vire, ki omogočajo te raziskave.
In adopting such national derogations, the national competent authority of the Member State must carefully consider any risk against the benefit of having the device available for immediate use.
Pristojni nacionalni organ države članice mora pri sprejemanju takih nacionalnih odstopanj skrbno preučiti vsa tveganja glede na korist, ki bi jo pomenila razpoložljivost pripomočka za takojšnjo uporabo.
Only the approaches for which a sufficient scientific basis has been established should be considered as best practice.
Kot najboljšo prakso je treba upoštevati le tiste pristope, za katere je vzpostavljena zadostna znanstvena podlaga.
In the EU, near-patient tests are intended to be used only by a health professional.
V EU naj bi teste ob pacientu uporabljali samo zdravstveni delavci.
At this stage, Member State competent authorities are generally not in favour of the use of COVID-19 self-tests in the current context of the pandemic and some have even prohibited the use of certain types of self-test (15) .
Pristojni organi držav članic se v trenutnih razmerah pandemije na splošno ne strinjajo z uporabo samotestov na COVID-19, nekatere pa so celo prepovedale uporabo nekaterih vrst samotestov (15) .
The Directive exempts devices that are manufactured and used within the same health institution (so-called in-house devices) from the abovementioned requirements.
V Direktivi so iz zgoraj navedenih zahtev izvzeti pripomočki, ki se proizvajajo in uporabljajo v isti zdravstveni ustanovi (tako imenovani interni pripomočki).
The Commission, in full cooperation with Member States and in consultation with the ECDC, will establish a network of COVID-19 reference laboratories across the Union, together with a platform to support them.
Komisija bo v polnem sodelovanju z državami članicami in posvetovanju z ECDC vzpostavila mrežo referenčnih laboratorijev za COVID-19 po vsej Uniji, skupaj s platformo za njihovo podporo.
For rapid antigen tests, it is important to choose RT-PCR as the comparator method; comparison with e.g. another rapid antigen test is not appropriate, as this approach would result in progressive degradation of references.
Za hitre antigenske teste je pomembno, da se kot primerjalna metoda izbere RT-PCR; primerjava z npr. drugim hitrim antigenskim testom ni primerna, saj bi ta pristop povzročil postopno poslabšanje referenc.
This will require close cooperation between regulators, health technology assessment bodies (23) , the ECDC, the COVID-19 reference laboratory network, research organisations and industry to ensure the most optimal outcome.
To bo zahtevalo tesno sodelovanje med regulativnimi organi, organi za vrednotenje zdravstvenih tehnologij (23) , ECDC, mrežo referenčnih laboratorijev za COVID-19, raziskovalnimi organizacijami in industrijo, da bi se zagotovil najboljši rezultat.
Directive 98/79/EC lays down that devices must be designed and manufactured in such a way that they are suitable for the intended purpose specified by the manufacturer, taking account of the generally acknowledged state of the art.
Direktiva 98/79/ES določa, da morajo biti pripomočki načrtovani in proizvedeni na tak način, da so primerni za predvidene namene, kot jih je navedel proizvajalec, ob upoštevanju splošno priznanega najsodobnejšega tehničnega razvoja.
The Commission, supported by the ECDC, health technology assessment experts and in vitro diagnostics competent authorities, will assist Member States with a centralised overview of available information on test performance and act as a single point of contact for management of this information.
Komisija bo ob podpori ECDC, strokovnjakov za vrednotenje zdravstvenih tehnologij in pristojnih organov za in vitro diagnostiko pomagala državam članicam s centraliziranim pregledom razpoložljivih informacij o učinkovitosti testov ter delovala kot enotna kontaktna točka za upravljanje teh informacij.
To make sure that sufficient numbers of well-performing tests and related reagents are available where they are needed, the industry and the Member States should make use of instruments at Union level to coordinate supply and demand, such as the clearing house (24) , rescEU and joint procurement.
da bi zagotovili razpoložljivost zadostnega števila učinkovitih testov in povezanih reagentov, kjer je to potrebno, bi morale industrija in države članice uporabljati instrumente na ravni Unije za usklajevanje ponudbe in povpraševanja, kot so posredovalni mehanizem (24) , rescEU in skupna javna naročila.
The Commission's Joint Research Centre has recently developed a positive control material for RT-PCR tests which is available to laboratories in Europe.
Skupno raziskovalno središče Komisije je nedavno razvilo pozitivni kontrolni material za teste RT-PCR, ki je na voljo laboratorijem v Evropi.
Activities will include facilitating exchange of information, identification of laboratories' needs, management and distribution of control samples, external quality assessment, method development, organisation and follow-up of comparative testing, and exchange of knowledge and skills.
Dejavnosti bodo vključevale olajševanje izmenjave informacij, opredeljevanje potreb laboratorijev, upravljanje in distribucijo kontrolnih vzorcev, zunanje ocenjevanje kakovosti, razvoj metod, organizacijo in spremljanje primerjalnega testiranja ter izmenjavo znanja in spretnosti.
In particular, the manufacturer must draw up a technical file which explicitly shows that the test is safe and performs as intended, by demonstrating compliance with the requirements laid down in Annex I of the Directive.
Proizvajalec mora zlasti pripraviti tehnično dokumentacijo, iz katere je izrecno razvidno, da je test varen in učinkovit, kot je predvideno, tako da se dokaže skladnost z zahtevami iz Priloge I k Direktivi.
Tests can be grouped by scientific rationale, type of technology, intended user and location of testing.
Teste je mogoče razvrstiti glede na znanstveno utemeljitev, vrsto tehnologije, predvidenega uporabnika in lokacijo testiranja.
For COVID-19 tests intended for use by health professionals, the CE-mark may be affixed following a declaration by the manufacturer that the requirements of the Directive are satisfied (declaration of conformity).
Pri testih na COVID-19, namenjenih zdravstvenim delavcem, se lahko nanje namesti oznaka CE, in sicer na podlagi izjave proizvajalca, da so zahteve iz Direktive izpolnjene (izjava o skladnosti).
For antibody tests, if a test specifies that it can be used on blood, serum and plasma samples, evidence should be provided that the test performs as intended on all those types of sample.
Pri testih na protitelesa je treba, kadar je navedeno, da se test lahko uporabi na vzorcih krvi, seruma in plazme, zagotoviti dokaze, da je test učinkovit pri vseh teh vrstah vzorcev, kot je predvideno.
As of early April 2020, the following approximate numbers of COVID-19 devices have been CE-marked under Directive 98/79/EC (7) : 78 for RT-PCR tests, 13 rapid antigen tests, 101 antibody tests, most of them rapid.
Od začetka aprila 2020 ima naslednje okvirno število pripomočkov za testiranje COVID-19 oznako CE v skladu z Direktivo 98/79/ES (7) : 78 testov RT-PCR, 13 hitrih antigenskih testov, 101 test na protitelesa (večina hitrih).
In addition, antibodies persist for some time after the infection has cleared.
Poleg tega so protitelesa prisotna v telesu še nekaj časa po koncu okužbe.
Testing for the presence of or past exposure to the SARS-CoV-2 virus is an essential aspect of combatting the COVID-19 outbreak and the associated public health crisis.
Testiranje prisotnosti virusa SARS-CoV-2 ali pretekle izpostavljenosti virusu je bistveni vidik boja proti izbruhu COVID-19 in s tem povezani krizi na področju javnega zdravja.
It provides elements to be considered by Member States in defining national strategies, and by economic operators in placing devices on the market, with the objective of ensuring that safe and effective devices for COVID-19-related testing are available in the EU.
Vsebuje elemente, ki jih morajo upoštevati države članice pri opredeljevanju nacionalnih strategij in gospodarski subjekti pri dajanju pripomočkov na trg, da bi zagotovili razpoložljivost varnih in učinkovitih pripomočkov za testiranje COVID-19 v EU.
Development of a positive control material which can be used for quality assessment of RT-PCR tests (21) and its distribution to laboratories across the EU.
razvoj pozitivnega kontrolnega materiala, ki ga je mogoče uporabiti za oceno kakovosti testov RT-PCR (21) , in njegova distribucija laboratorijem po vsej EU;