natgillin/translations-raw huggingface dataset:
Where specific devices have no analytical or clinical performance or specific performance requirements are not applicable, it is appropriate to justify in the performance evaluation plan, and related reports, omissions relating to such requirements.
Kadar specifični pripomočki nimajo nikakršnih analitičnih ali kliničnih učinkov ali pa se zanje ne uporabljajo nikakršne specifične zahteve glede učinkovitosti, bi bilo ustrezno v načrtu ocene učinkovitosti in sorodnih poročilih utemeljiti, zakaj izpolnjevanje teh zahtev ni potrebno.
The rules on performance studies 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 performance studies conducted in the Union to be accepted as documentation outside the Union and to make it easier for the results of performance studies conducted outside the Union in accordance with international guidelines to be accepted within the Union.
Pravila o študijah učinkovitosti bi morala biti skladna z dogovorjenimi mednarodnimi smernicami na tem področju, kot je mednarodni standard ISO 14155:2011 o dobri klinični praksi pri kliničnih raziskavah medicinskih pripomočkov na ljudeh, da bi omogočili, da so rezultati študij učinkovitosti, ki se opravijo v Uniji, kot dokumentacija lažje sprejeti zunaj Unije in da so rezultati študij učinkovitosti, ki se opravijo zunaj Unije v skladu z mednarodnimi smernicami, lažje sprejeti v Uniji.
It should be left to the Member State where a performance study is to be conducted to determine the appropriate authority to be involved in the assessment of the application to conduct a performance study and to organise the involvement of ethics committees within the timelines for the authorisation of that performance study as set out in this Regulation.
Državi članici, v kateri bo potekala študija učinkovitosti, bi morali prepustiti določitev ustreznega organa, ki bo sodeloval pri oceni vloge za izvedbo študije učinkovitosti, ter organizacijo sodelovanja odborov za etiko v okviru rokov za odobritev te študije učinkovitosti, kot jih določa ta uredba.
In that context, Member States should ensure the involvement of laypersons, in particular patients or patients' organisations.
Države članice bi morale pri tem odločanju zagotoviti sodelovanje nestrokovnjakov, zlasti pacientov oziroma organizacij pacientov.
An electronic system should be set up at Union level to ensure that every interventional clinical performance study and other performance study involving risks for the subjects of the studies is recorded and reported in a publicly accessible database.
Na ravni Unije bi bilo treba vzpostaviti elektronski sistem za zagotovitev, da je vsaka intervencijska študija klinične učinkovitosti in druga študija učinkovitosti, ki vključuje tveganja za udeležence v študiji, evidentirana in navedena v javno dostopni podatkovni zbirki.
To protect the right to protection of personal data, recognised by Article 8 of the Charter of Fundamental Rights of the European Union (‘the Charter’), no personal data of subjects participating in a performance study should be recorded in the electronic system.
Za zaščito pravice do varstva osebnih podatkov, ki je priznana v členu 8 Listine Evropske unije o temeljnih pravicah (v nadaljnjem besedilu: Listina), se v elektronskem sistemu ne bi smeli evidentirati nobeni osebni podatki udeležencev v študiji učinkovitosti.
To ensure synergies with the area of clinical trials on medicinal products, the electronic system on performance studies should be interoperable with the EU database to be set up for clinical trials on medicinal products for human use.
Za zagotovitev sinergij s kliničnimi preskušanji zdravil bi moral biti elektronski sistem za študije učinkovitosti interoperabilen s podatkovno zbirko EU, ki bo vzpostavljena za klinična preskušanja zdravil za uporabo v humani medicini.
Where an interventional clinical performance study or another performance study involving risks for the subjects is to be conducted in more than one Member State, the sponsor should have the possibility of submitting a single application in order to reduce administrative burden.
Kadar se intervencijska študija klinične učinkovitosti ali druga študija učinkovitosti, ki vključuje tveganja za udeležence, izvaja v več kot eni državi članici, bi sponzor moral imeti možnost, da zaradi zmanjšanja upravnega bremena predloži enotno vlogo.
In order to allow for resource-sharing and to ensure consistency regarding the assessment of the health and safety-related aspects of the device for performance study and of the scientific design of that performance study, the procedure for the assessment of such single application should be coordinated between the Member States under the direction of a coordinating Member State.
Da bi se omogočila skupna uporaba virov in zagotovila doslednost pri oceni zdravstvenih in varnostnih vidikov pripomočka za študijo učinkovitosti ter znanstvene zasnove te študije učinkovitosti, bi bilo treba med državami članicami uskladiti postopek ocenjevanja te enotne vloge pod vodstvom države članice koordinatorke.
Such coordinated assessment should not include the assessment of intrinsically national, local and ethical aspects of a performance study, including informed consent.
Ta usklajena ocena ne bi smela vključevati ocene značilnih nacionalnih, lokalnih in etičnih vidikov študije učinkovitosti, vključno s privolitvijo po seznanitvi.
For an initial period of seven years from the date of application of this Regulation, Member States should be able to participate on a voluntary basis in the coordinated assessment.
Za začetno obdobje sedmih let od datuma začetka uporabe te uredbe bi morale države članice imeti možnost, da prostovoljno sodelujejo pri usklajeni oceni.
After that period, all Member States should be obliged to participate in the coordinated assessment.
Po izteku tega obdobja, bi moralo biti sodelovanje držav članic pri usklajeni oceni obvezno.
The Commission, based on the experience gained from the voluntary coordination between Member States, should draw up a report on the application of the relevant provisions regarding the coordinated assessment procedure.
Komisija bi morala na podlagi izkušenj, pridobljenih pri prostovoljnem usklajevanju med državami članicami, sestaviti poročilo o uporabi zadevnih določb o usklajenem postopku ocenjevanja.
In the event that the findings of the report are negative, the Commission should submit a proposal to extend the period of participation on a voluntary basis in the coordinated assessment procedure.
Kadar so ugotovitve iz poročila negativne, bi morala Komisija vložiti predlog za podaljšanje roka prostovoljnega sodelovanja v usklajenem postopku ocenjevanja.
Sponsors should report certain adverse events and device deficiencies that occur during interventional clinical performance studies and other performance studies involving risks for the subjects to the Member States in which those studies are being conducted.
Sponzorji bi morali državam članicam, v katerih se te študije opravljajo, poročati o določenih neželenih dogodkih in pomanjkljivostih pripomočka, ki se pojavijo med intervencijskimi študijami klinične učinkovitosti in drugimi študijami učinkovitosti, ki vključujejo tveganja za udeležence študij.
Member States should have the possibility of terminating or suspending the studies or revoking the authorisation for those studies, if considered necessary to ensure a high level of protection of the subjects participating in such studies.
Države članice bi morale imeti možnost, da študije ustavijo ali jih prekinejo ali prekličejo odobritev zanje, če menijo, da je to potrebno za zagotavljanje visoke zaščite udeležencev v teh študijah.
Such information should be communicated to the other Member States.
Take informacije bi bilo treba sporočiti drugim državam članicam.
The sponsor of a performance study should submit a summary of results of the performance study that is easily understandable for the intended user together with the performance study report, where applicable, within the timelines laid down in this Regulation.
Sponzor študije učinkovitosti, bi moral v rokih, določenih v tej uredbi, skupaj predložiti povzetek rezultatov študije učinkovitosti, ki je lahko razumljiv za predvidenega uporabnika, in poročilo o študiji učinkovitosti, kjer je to ustrezno.
With exemption of some general requirements, this Regulation should only cover performance studies intended to gather scientific data for the purpose of demonstrating conformity of devices.
Te uredba bi morala z izjemo nekaterih splošnih zahtev zajemati le študije učinkovitosti, katerih namen je zbiranje znanstvenih podatkov za dokazovanje skladnosti pripomočkov.
It is necessary to clarify that performance studies using left-over specimens need not be authorised.
Treba je pojasniti, da študij učinkovitosti, pri katerih se uporabljajo ostanki vzorcev, ni treba odobriti.
Nevertheless, the general requirements and other additional requirements with regard to data protection and the requirements applicable to procedures that are performed in accordance with national law such as ethical review should continue to apply to all performance studies, including when using left-over specimens.
Vendar bi morale za vse študije učinkovitosti, tudi tiste, pri katerih se uporabljajo ostanki vzorcev, še naprej veljati splošne in druge dodatne zahteve glede varstva podatkov ter zahteve, ki se uporabljajo pri postopkih, izvedenih v skladu z nacionalnim pravom, npr. etičnem pregledu.
The principles of replacement, reduction and refinement in the area of animal experimentation laid down in the Directive 2010/63/EU of the European Parliament and the Council [16] should be observed.
Spoštovati bi bilo treba načela zamenjave, zmanjšanja in izboljšanja s področja poskusov na živalih, kot so določena v Direktivi 2010/63/EU Evropskega parlamenta in Sveta [16].
To that end, manufacturers should establish a comprehensive post-market surveillance system, set up under their quality management system and based on a post-market surveillance plan.
V ta namen bi morali proizvajalci v okviru svojega sistema vodenja kakovosti in na podlagi načrta nadzora po dajanju na trg vzpostaviti celovit sistem nadzora po dajanju na trg.
Relevant data and information gathered through post-market surveillance, as well as lessons learned from any implemented preventive and/or corrective actions, should be used to update any relevant part of technical documentation, such as those relating to risk assessment and performance evaluation, and should also serve the purposes of transparency.
Zadevne podatke in informacije, zbrane v okviru nadzora po dajanju na trg, ter izkušnje, pridobljene pri izvedenih preventivnih in/ali korektivnih ukrepih, bi bilo treba uporabiti za posodobitev vseh ustreznih delov tehnične dokumentacije, kot so deli o oceni tveganja in oceni učinkovitosti, pa tudi za zagotovitev večje preglednosti.
Member States should take appropriate measures to raise awareness among healthcare professionals, users and patients about the importance of reporting incidents.
Države članice bi morale sprejeti ustrezne ukrepe za večjo ozaveščenost zdravstvenih delavcev, uporabnikov in pacientov o pomenu sporočanja zapletov.
The national competent authorities should inform manufacturers of any suspected serious incident and, where a manufacturer confirms that such an incident might have occurred, the authorities concerned should ensure that appropriate follow-up action is taken in order to minimise recurrence of such incidents.
Pristojni nacionalni organi bi morali proizvajalce obvestiti o vsakem sumu na resni zaplet, kadar proizvajalec potrdi morebiten pojav resnega zapleta, pa bi morali zadevni organi zagotoviti sprejetje ustrezni nadaljnjih ukrepov, da se zmanjša verjetnost ponovitve takih zapletov.
The evaluation of reported serious incidents and field safety corrective actions should be conducted at national level but coordination should be ensured where similar incidents have occurred or field safety corrective actions have to be carried out in more than one Member State, with the objective of sharing resources and ensuring consistency regarding the corrective action.
Oceno sporočenih resnih zapletov in varnostnih korektivnih ukrepov bi bilo treba izvesti na nacionalni ravni, vendar bi bilo treba v primeru pojava podobnih zapletov ali izvedbe varnostnih korektivnih ukrepov v več kot eni državi članici zagotoviti usklajevanje, da se omogoči skupna uporaba virov in zagotovi doslednost pri korektivnih ukrepih.
The reporting of serious adverse events or device deficiencies during interventional clinical performance studies and other performance studies involving risks for the subjects, and the reporting of serious incidents occurring after a device has been placed on the market should be clearly distinguished to avoid double reporting.
Poročanje o resnih neželenih dogodkih ali pomanjkljivostih pripomočka med izvajanjem intervencijskih študij klinične učinkovitosti in drugih študij učinkovitosti, ki vključujejo tveganja za udeležence študij, ter poročanje o resnih zapletih, ki se pojavijo po dajanju pripomočka na trg, bi bilo treba jasno ločiti, da bi preprečili dvojno poročanje.
Any statistically significant increase in the number or severity of incidents that are not serious or in expected erroneous results that could have a significant impact on the benefit-risk analysis and which could lead to unacceptable risks should be reported to the competent authorities in order to permit their assessment and the adoption of appropriate measures.
Vsako statistično pomembno povečanje števila ali resnosti zapletov, ki niso resni zapleti, ali pričakovanih napačnih rezultatov, ki bi lahko bistveno vplivalo na analizo razmerja med koristmi in tveganji ter povzročilo nesprejemljiva tveganja, bi bilo treba sporočiti pristojnim organom, da bi lahko to povečanje ocenili in sprejeli ustrezne ukrepe.
An expert committee, the MDCG, composed of persons designated by the Member States based on their role and expertise in the field of medical devices including in vitro diagnostic medical devices, should be established in accordance with the conditions and modalities defined in Regulation (EU) 2017/745 to fulfil the tasks conferred on it by this Regulation and by Regulation (EU) 2017/745, to provide advice to the Commission and to assist the Commission and the Member States in ensuring a harmonised implementation of this Regulation.
V skladu s pogoji in pravili iz Uredbe (EU) 2017/745 bi bilo treba ustanoviti strokovni odbor, to je Koordinacijsko skupino za medicinske pripomočke sestavljeno iz članov, ki jih imenujejo države članice na podlagi njihove vloge in izkušenj na področju medicinskih pripomočkov, vključno z in vitro diagnostičnimi medicinski pripomočki, ki bo izpolnjevala naloge iz te uredbe in Uredbe (EU) 2017/745, svetovala Komisiji ter pomagala Komisiji in državam članicam pri zagotavljanju harmoniziranega izvajanja te uredbe.
The MDCG should be able to establish subgroups in order to have access to necessary in-depth technical expertise in the field of medical devices including in vitro diagnostic medical devices.
Koordinacijska skupina za medicinske pripomočke bi morala imeti možnost ustanoviti podskupine, ki bodo zagotavljale dostop do potrebnega poglobljenega tehničnega strokovnega znanja s področja medicinskih pripomočkov, vključno z in vitro diagnostičnimi medicinskimi pripomočki.
Closer coordination between national competent authorities through information exchange and coordinated assessments under the direction of a coordinating authority is essential for ensuring a uniform high level of health and safety protection within the internal market, in particular in the areas of performance studies and vigilance.
Izmenjava informacij in usklajeno ocenjevanje pod vodstvom koordinacijskega organa vodita v tesnejše usklajevanje med pristojnimi nacionalnimi organi, ki je bistveno za zagotavljanje trajno visoke ravni varovanja zdravja in varnosti na notranjem trgu, zlasti na področju študij učinkovitosti in vigilance.
The Union and, where appropriate, the Member States should actively participate in international regulatory cooperation in the field of devices to facilitate the exchange of safety-related information regarding devices and foster the further development of international regulatory guidelines that promote the adoption in other jurisdictions of regulations that lead to a level of health and safety protection equivalent to that set by this Regulation.
Unija in po potrebi države članice bi morale biti dejavne v mednarodnem regulativnem sodelovanju na področju pripomočkov, da bi se tako olajšala izmenjava informacij o varnosti pripomočkov in podprl nadaljnji razvoj mednarodnih regulativnih smernic, ki spodbujajo sprejetje predpisov, s katerimi se zagotavlja enaka raven varovanja zdravja in varnosti kot s to uredbo, v drugih pravnih sistemih.
Member States should take all necessary measures to ensure that the provisions of this Regulation are implemented, including by laying down effective, proportionate and dissuasive penalties for their infringement.
Države članice bi morale sprejeti vse potrebne ukrepe za zagotovitev izvajanja določb iz te uredbe ter določiti učinkovite, sorazmerne in odvračilne kazni za kršitve teh določb.
Whilst this Regulation should not affect the right of Member States to levy fees for activities at national level, Member States should, in order to ensure transparency, inform the Commission and the other Member States before they decide on the level and structure of such fees.
Medtem ko ta uredba ne bi smela posegati v pravico držav članic, da zaračunavajo pristojbine za dejavnosti na nacionalni ravni, bi morale države članice Komisijo in druge države članice obvestiti preden sprejmejo odločitev o višini in strukturi teh pristojbin, da se tako zagotovi preglednost.
This Regulation should be applied by the Member States in accordance with those rights and principles.
Države članice bi morale to uredbo uporabljati v skladu z navedenimi pravicami in načeli.
The power to adopt delegated acts in accordance with Article 290 TFEU should be delegated to the Commission in order to amend certain non-essential provisions of this Regulation.
Na Komisijo bi bilo treba prenesti pooblastilo za sprejemanje delegiranih aktov za spremembo določenih nebistvenih določb te uredbe v skladu s členom 290 PDEU.
It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law Making [17].
Zlasti je pomembno, da se Komisija pri svojem pripravljalnem delu ustrezno posvetuje, vključno na ravni strokovnjakov, in da se ta posvetovanja izvedejo v skladu z načeli, določenimi v Medinstitucionalnem sporazumu z dne 13. aprila 2016 o boljši pripravi zakonodaje [17].
In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with preparation of delegated acts.
Za zagotovitev enakopravnega sodelovanja pri pripravi delegiranih aktov Evropski parlament in Svet zlasti prejmeta vse dokumente sočasno s strokovnjaki iz držav članic, njuni strokovnjaki pa se sistematično lahko udeležujejo sestankov strokovnih skupin Komisije, ki zadevajo pripravo delegiranih aktov.
The advisory procedure should be used for implementing acts that set out the form and presentation of the data elements of manufacturers' summaries of safety and performance, and that establish the model for certificates of free sale, given that such implementing acts are of a procedural nature and do not directly have an impact on health and safety at Union level.
Svetovalni postopek bi bilo treba uporabiti za izvedbene akte, ki določajo obliko in predstavitev podatkovnih elementov v povzetkih proizvajalcev o varnosti in učinkovitosti ter ki opredeljujejo vzorec certifikatov o prosti prodaji, saj so ti izvedbeni akti postopkovne narave in ne vplivajo neposredno na zdravje in varnost na ravni Unije.
In order to enable it to designate issuing entities and EU reference laboratories, implementing powers should be conferred on the Commission.
Na Komisijo bi bilo treba prenesti izvedbena pooblastila, da bi lahko imenovala subjekte za izdajanje in referenčne laboratorije EU.
To allow economic operators, especially SMEs, notified bodies, Member States and the Commission to adapt to the changes introduced by this Regulation and to ensure its proper application, it is appropriate to provide for a sufficient transitional period for that adaptation and for the organisational arrangements that are to be made.
Da bi se lahko gospodarski subjekti, zlasti mala in srednja podjetja (MSP), priglašeni organi, države članice in Komisija prilagodili spremembam, ki jih uvaja ta uredba, in da bi zagotovili njeno pravilno uporabo, je ustrezno zagotoviti dovolj dolgo prehodno obdobje za to prilagoditev in sprejetje potrebnih organizacijskih ureditev.
However, certain parts of the Regulation that directly affect Member States and the Commission should be implemented as soon as possible.
Vendar bi bilo treba določene dele uredbe, ki neposredno zadevajo države članice in Komisijo, začeti izvajati čim prej.
It is also particularly important that, by the date of application of this Regulation, a sufficient number of notified bodies be designated in accordance with the new requirements so as to avoid any shortage of devices on the market.
Zlasti je tudi pomembno, da se do datuma začetka uporabe te uredbe imenuje zadostno število priglašenih organov v skladu z novimi zahtevami in tako prepreči pomanjkanje pripomočkov na trgu.
Nonetheless, it is necessary that any designation of a notified body in accordance with the requirements of this Regulation prior to the date of its application be without prejudice to the validity of the designation of those notified bodies under Directive 98/79/EC and to their capacity to continue issuing valid certificates under that Directive until the date of application of this Regulation.
Kljub temu je treba zagotoviti, da imenovanja priglašenih organov v skladu z zahtevami iz te uredbe, opravljena pred datumom začetka njene uporabe, ne posegajo v veljavnost imenovanj priglašenih organov, opravljenih v skladu z Direktivo 98/79/ES, ter v njihovo zmožnost, da do datuma začetka uporabe te uredbe še naprej izdajajo veljavne certifikate v skladu z navedeno direktivo.
In order to ensure a smooth transition to the new rules for registration of devices and of certificates, the obligation to submit the relevant information to the electronic systems set up at Union level pursuant to this Regulation should, in the event that the corresponding IT systems are developed according to plan, only become fully effective from 18 months after the date of application of this Regulation.
Za zagotovitev nemotenega prehoda na nova pravila za registracijo pripomočkov in certifikatov bi morala obveznost predložitve ustreznih informacij v elektronske sisteme, vzpostavljene na ravni Unije na podlagi te uredbe, začeti veljati šele 18 mesecev po datumu začetka uporabe te uredbe, če bodo ustrezni sistemi IT razviti v predvidenem času.
During this transitional period, certain provisions of Directive 98/79/EC should remain in force.
V tem prehodnem obdobju bi se morale še naprej uporabljati nekatere določbe iz Direktive 98/79/ES.