natgillin/translations-raw huggingface dataset:
The classification rules, which are based on the vulnerability of the human body, should take into account the potential risks associated with the technical design and manufacture of the devices.
Pri klasifikacijskih pravilih, ki temeljijo na spoznanjih o ranljivosti človeškega telesa, bi bilo treba upoštevati morebitna tveganja, povezana s tehnično zasnovo in izdelavo pripomočkov.
To maintain the same level of safety as provided by Directive 90/385/EEC, active implantable devices should be in the highest risk class.
Za ohranitev enake stopnje varnosti, kakor je določena z Direktivo 90/385/EGS, bi bilo treba aktivne pripomočke za vsaditev razvrstiti v najvišji razred tveganja.
Rules under the old regime applied to invasive devices do not sufficiently take account of the level of invasiveness and potential toxicity of certain devices which are introduced into the human body.
V pravilih, ki se v skladu s staro ureditvijo uporabljajo za invazivne pripomočke, nista v zadostni meri upoštevani stopnja invazivnosti in potencialna toksičnost nekaterih pripomočkov, vstavljenih v človeško telo.
In order to obtain a suitable risk-based classification of devices that are composed of substances or of combinations of substances that are absorbed by or locally dispersed in the human body, it is necessary to introduce specific classification rules for such devices.
Da bi pridobili ustrezno razvrstitev pripomočkov na podlagi tveganja, sestavljenih iz snovi ali kombinacij snovi, ki jih človeško telo absorbira ali se lokalno razpršijo v človeškem telesu, je treba uvesti posebna pravila za razvrščanje takih pripomočkov.
The classification rules should take into account the place where the device performs its action in or on the human body, where it is introduced or applied, and whether a systemic absorption of the substances of which the device is composed, or of the products of metabolism in the human body of those substances occurs.
Pravila za razvrščanje bi morala upoštevati, kje v ali na človeškem telesu pripomoček opravlja svojo vlogo, kje je vstavljen ali nameščen in ali je prisotna sistemska absorpcija snovi, ki sestavljajo pripomoček, ali produktov presnove teh snovi v človeškem telesu.
The conformity assessment procedure for class I devices should be carried out, as a general rule, under the sole responsibility of manufacturers in view of the low level of vulnerability associated with such devices.
Zaradi nizke stopnje tveganja pripomočkov razreda I bi moral biti postopek ugotavljanja skladnosti teh pripomočkov praviloma v izključni pristojnosti proizvajalcev.
For class IIa, class IIb and class III devices, an appropriate level of involvement of a notified body should be compulsory.
Za pripomočke razredov IIa, IIb in III bi morala biti obvezna ustrezna raven vključenosti priglašenega organa.
The conformity assessment procedures for devices should be further strengthened and streamlined whilst the requirements for notified bodies as regards the performance of their assessments should be clearly specified to ensure a level playing field.
Za zagotovitev enakih pogojev bi bilo treba postopke ugotavljanja skladnosti pripomočkov nadalje zaostriti in poenotiti, zahteve glede izvajanja ocen, ki je naloga priglašenih organov, pa bi bilo treba jasno opredeliti.
It is appropriate that certificates of free sale contain information that makes it possible to use Eudamed in order to obtain information on the device, in particular with regard to whether it is on the market, withdrawn from the market or recalled, and on any certificate on its conformity.
Ustrezno je, da certifikati o prosti prodaji vsebujejo informacije o možnosti uporabe Eudameda, da bi tako pridobili informacije o pripomočku, zlasti informacije, ali je bil dan na trg, umaknjen s trga ali odpoklican, ter informacije o certifikatih, ki potrjujejo njegovo skladnost.
To ensure a high level of safety and performance, demonstration of compliance with the general safety and performance requirements laid down in this Regulation should be based on clinical data that, for class III devices and implantable devices should, as a general rule, be sourced from clinical investigations that have been carried out under the responsibility of a sponsor.
Za zagotovitev visoke stopnje varnosti in učinkovitosti bi moralo dokazovanje skladnosti s splošnimi zahtevami glede varnosti in učinkovitosti, določenimi v tej uredbi, temeljiti na kliničnih podatkih, ki bi za pripomočke razreda III in pripomočke za vsaditev morali praviloma biti pridobljeni iz kliničnih raziskav, za izvedbo katerih je odgovoren sponzor.
It should be possible both for the manufacturer and for another natural or legal person to be the sponsor taking responsibility for the clinical investigation.
Omogočiti bi bilo treba, da tako proizvajalec kot druga fizična ali pravna oseba opravlja vlogo sponzorja, ki prevzame odgovornost za klinično raziskavo.
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.
Pravila o kliničnih raziskavah 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 kliničnih raziskav, ki se opravijo v Uniji, kot dokumentacija lažje sprejeti zunaj Unije in da so rezultati kliničnih raziskav, ki se opravijo zunaj Unije v skladu z mednarodnimi smernicami, lažje sprejeti v Uniji.
In addition, the rules should be in line with the most recent version of the World Medical Association Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects.
Pravila bi morala biti skladna tudi z zadnjo različico Helsinške deklaracije Svetovnega zdravniškega združenja o etičnih načelih za zdravstvene raziskave na ljudeh.
It should be left to the Member State where a clinical investigation is to be conducted to determine the appropriate authority to be involved in the assessment of the application to conduct a clinical investigation and to organise the involvement of ethics committees within the timelines for the authorisation of that clinical investigation as set out in this Regulation.
Državi članici, v kateri bo potekala klinična raziskava, bi morali prepustiti določitev ustreznega organa, ki bo sodeloval pri oceni vloge za izvedbo klinične raziskave, ter organizacijo sodelovanja odborov za etiko v okviru rokov za odobritev te klinične raziskave, kot jih določa ta uredba.
Such decisions are a matter of internal organisation for each Member State.
Take odločitve so stvar notranje organizacije vsake države članice.
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.
They should also ensure that the necessary expertise is available.
Zagotoviti bi morale tudi razpoložljivost potrebnega strokovnega znanja.
Where, in the course of a clinical investigation, harm caused to a subject leads to the civil or criminal liability of the investigator or the sponsor being invoked, the conditions for liability in such cases, including issues of causality and the level of damages and sanctions, should remain governed by national law.
Kadar se zaradi škode, ki jo udeleženec utrpi med kliničnimi raziskavami, uveljavlja civilna ali kazenska odgovornost raziskovalca ali sponzorja, bi moralo pogoje za odškodninsko odgovornost v teh primerih, vključno z vprašanji vzročne zveze in višino odškodnin ter stopnjo sankcij, še naprej urejati nacionalno pravo.
An electronic system should be set up at Union level to ensure that every clinical investigation is recorded and reported in a publicly accessible database.
Na ravni Unije bi bilo treba vzpostaviti elektronski sistem za zagotovitev, da je vsaka klinična raziskava evidentirana in navedena v javno dostopni podatkovni zbirki.
To protect the right to the 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 clinical investigation 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 klinični raziskavi.
To ensure synergies with the area of clinical trials on medicinal products, the electronic system on clinical investigations 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 klinične raziskave interoperabilen s podatkovno zbirko EU, ki bo vzpostavljena za klinična preskušanja zdravil za uporabo v humani medicini.
Where a clinical investigation 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 klinična raziskava 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 investigational device and of the scientific design of that clinical investigation, 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, ki je predmet raziskave, ter znanstvene zasnove te klinične raziskave, 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 clinical investigation, including informed consent.
Ta usklajena ocena ne bi smela vključevati ocene značilnih nacionalnih, lokalnih in etičnih vidikov klinične raziskave, 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 za prostovoljno sodelovanje v usklajenem postopku ocenjevanja.
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.
Sponzorji bi morali državam članicam, v katerih se te klinične raziskave opravljajo, poročati o določenih neželenih dogodkih in pomanjkljivostih pripomočka, ki se pojavijo med temi raziskavami.
Member States should have the possibility of terminating or suspending the investigations or revoking the authorisation for those investigations, if considered necessary to ensure a high level of protection of the subjects participating in a clinical investigation.
Države članice bi morale imeti možnost, da te raziskave ustavijo ali jih prekinejo ali prekličejo odobritev zanje, če menijo, da je to potrebno za zagotavljanje visoke zaščite udeležencev v klinični raziskavi.
Such information should be communicated to the other Member States.
Take informacije bi bilo treba sporočiti drugim državam članicam.
The sponsor of a clinical investigation should submit a summary of results of the clinical investigation that is easily understandable for the intended user together with the clinical investigation report, where applicable, within the timelines laid down in this Regulation.
Sponzor klinične raziskave bi moral v rokih, določenih v tej uredbi, skupaj predložiti povzetek rezultatov klinične raziskave, ki je lahko razumljiv za predvidenega uporabnika, in poročilo o klinični raziskavi, kjer je to ustrezno.
Where it is not possible to submit the summary of the results within the defined timelines for scientific reasons, the sponsor should justify this and specify when the results will be submitted.
Kadar tega povzetka iz znanstvenih razlogov ni mogoče predložiti v določenih rokih, bi moral sponzor to utemeljiti in navesti, kdaj bodo rezultati predloženi.
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.
Ta uredba bi morala zajemati klinične raziskave, katerih namen je zbiranje kliničnih dokazov, da se dokaže skladnost pripomočkov, in tudi določati osnovne zahteve glede etičnih in znanstvenih ocen za druge vrste kliničnih raziskav medicinskih pripomočkov.
Incapacitated subjects, minors, pregnant women and breastfeeding women require specific protection measures.
Udeleženci, ki niso sposobni odločati o sebi, mladoletniki, nosečnice in doječe matere potrebujejo posebne zaščitne ukrepe.
However, it should be left to Member States to determine the legally designated representatives of incapacitated subjects and minors.
Vendar pa bi morali državam članicam prepustiti, da same določijo zakonito imenovane zastopnike udeležencev, ki niso sposobni odločati o sebi, in mladoletnikov.
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 of the Council [24] 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 [24].
In particular, the unnecessary duplication of tests and studies should be avoided.
Zlasti bi se morali izogibati nepotrebnemu podvajanju preskusov in študij.
Manufacturers should play an active role during the post-market phase by systematically and actively gathering information from post-market experience with their devices in order to update their technical documentation and cooperate with the national competent authorities in charge of vigilance and market surveillance activities.
Proizvajalci bi morali imeti aktivno vlogo v obdobju po dajanju na trg ter sistematično in dejavno zbirati informacije o izkušnjah s svojimi pripomočki po dajanju na trg, da bi tako lahko posodabljali svojo tehnično dokumentacijo in sodelovali z nacionalnimi pristojnimi organi, zadolženimi za dejavnosti vigilance in nadzora trga.
To this 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 clinical evaluation, and should also serve the purpose 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 klinični oceni, pa tudi za zagotovitev večje preglednosti.
In order to better protect health and safety regarding devices on the market, the electronic system on vigilance for devices should be made more effective by creating a central portal at Union level for reporting serious incidents and field safety corrective actions.
Za boljšo zaščito zdravja in varnosti v zvezi s pripomočki na trgu bi morali izboljšati učinkovitost elektronskega sistema o vigilanci pripomočkov ter v ta namen vzpostaviti osrednji portal na ravni Unije za poročanje o resnih zapletih in varnostnih korektivnih ukrepih.
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.
Healthcare professionals, users and patients should be encouraged and enabled to report suspected serious incidents at national level using harmonised formats.
Zdravstvene delavce, uporabnike in paciente bi bilo treba spodbujati in jim dati možnost, da v harmonizirani obliki sporočajo sume na resne zaplete na nacionalni ravni.
The national competent authorities should inform manufacturers of any suspected serious incidents and, where a manufacturer confirms that such an incident has 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 resne zaplete, kadar proizvajalec potrdi pojav resnega zapleta, pa bi morali zadevni organi zagotoviti sprejetje ustreznih 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.
In the context of the investigation of incidents, the competent authorities should take into account, where appropriate, the information provided by and views of relevant stakeholders, including patient and healthcare professionals' organisations and manufacturers' associations.
Pri preiskavi zapletov bi morali pristojni organi, kadar je primerno, upoštevati informacije in stališča zadevnih deležnikov, tudi organizacij pacientov ter združenj zdravstvenih delavcev in proizvajalcev.
The reporting of serious adverse events or device deficiencies during clinical investigations 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 kliničnimi raziskavami in poročanje o resnih zapletih, ki se pojavijo potem, ko je bil pripomoček dan na trg, bi bilo treba jasno ločiti, da bi se izognili dvojnemu poročanju.
Rules on market surveillance should be included in this Regulation to reinforce the rights and obligations of the national competent authorities, to ensure effective coordination of their market surveillance activities and to clarify the applicable procedures.
Pravila o nadzoru trga bi bilo treba vključiti v to uredbo, da bi tako okrepili pravice in obveznosti pristojnih nacionalnih organov, zagotovili učinkovito usklajevanje njihovih dejavnosti nadzora trga in razjasnili veljavne postopke.
Any statistically significant increase in the number or severity of incidents that are not serious or in expected side-effects 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 stranskih učinkov, ki bi lahko bistveno vplivalo na analizo razmerja med koristmi in tveganji ter povzročilo nesprejemljiva tveganja, bi bilo treba sporočiti pristojnim organom, da se omogoči njihova ocena in sprejetje ustreznih ukrepov.
An expert committee, the Medical Device Coordination Group (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 to fulfil the tasks conferred on it by this Regulation and by Regulation (EU) 2017/746 of the European Parliament and of the Council [25], to provide advice to the Commission and to assist the Commission and the Member States in ensuring a harmonised implementation of this Regulation.
Ustanoviti bi bilo treba strokovni odbor, tj. Koordinacijsko skupino za medicinske pripomočke, sestavljeno iz članov, ki jih imenujejo države članice na podlagi njihove vloge in strokovnega znanja na področju medicinskih pripomočkov, vključno z in vitro diagnostičnimi medicinskimi pripomočki, ki bo izpolnjevala naloge, podeljene s to uredbo in Uredbo (EU) 2017/746 Evropskega parlamenta in Sveta [25], 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 znanje s področja medicinskih pripomočkov, vključno z in vitro diagnostičnimi medicinskimi pripomočki.
When establishing subgroups, appropriate consideration should be given to the possibility of involving existing groups at Union level in the field of medical devices.
Pri ustanavljanju podskupin bi bilo treba ustrezno upoštevati možnost vključitve obstoječih skupin, ki so na ravni Unije aktivne na področju medicinskih pripomočkov.