natgillin/translations-raw huggingface dataset:
Expert panels and expert laboratories should be designated by the Commission on the basis of their up-to-date clinical, scientific or technical expertise, with the aim of providing scientific, technical and clinical assistance to the Commission, the MDCG, manufacturers and notified bodies in relation to the implementation of this Regulation.
Komisija bi strokovne odbore in strokovne laboratorije morala imenovati na podlagi njihovega najnovejšega kliničnega, znanstvenega ali tehničnega strokovnega znanja, da bodo Komisiji, Koordinacijski skupini za medicinske pripomočke, proizvajalcem in priglašenim organom zagotavljali znanstveno, tehnično in klinično pomoč pri izvajanju te uredbe.
Moreover, expert panels should fulfil the tasks of providing an opinion on clinical evaluation assessment reports of notified bodies in the case of certain high-risk devices.
V primeru določenih pripomočkov z visoko stopnjo tveganja bi morali strokovni odbori dajati tudi mnenja glede poročil priglašenih organov o vrednotenju klinične ocene.
Closer coordination between national competent authorities through information exchange and coordinated assessments under the direction of a coordinating authority is essential for ensuring a consistently high level of health and safety protection within the internal market, in particular in the areas of clinical investigations 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 kliničnih raziskav in vigilance.
The principle of coordinated exchange and assessment should also apply across other authority activities described in this Regulation, such as the designation of notified bodies and should be encouraged in the area of market surveillance of devices.
Načelo usklajene izmenjave in ocenjevanja bi moralo veljati tudi za vse druge dejavnosti organa, opisane v tej uredbi, kot je imenovanje priglašenih organov, in bi ga bilo treba spodbujati na področju nadzora trga s pripomočki.
Joint working, coordination and communication of activities should also lead to more efficient use of resources and expertise at national level.
Skupno delo, usklajevanje in sporočanje dejavnosti bi moralo prispevati tudi k bolj učinkoviti uporabi virov in strokovnega znanja na nacionalni ravni.
The Commission should provide scientific, technical and corresponding logistical support to coordinating national authorities and ensure that the regulatory system for devices is effectively and uniformly implemented at Union level based on sound scientific evidence.
Komisija bi morala koordinacijskim nacionalnim organom nuditi znanstveno, tehnično in ustrezno logistično podporo ter zagotavljati učinkovito in enotno izvajanje regulativnega sistema za pripomočke na ravni Unije na podlagi trdnih znanstvenih dokazov.
The Union and, where appropriate, the Member States should actively participate in international regulatory cooperation in the field of medical devices to facilitate the exchange of safety-related information regarding medical devices and to 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 medicinskih pripomočkov, da bi se tako olajšala izmenjava informacij o varnosti medicinskih 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.
In order to further ensure transparency, the structure and level of the fees should be publicly available on request.
Za nadaljnjo zagotovitev preglednosti bi morali biti struktura in višina pristojbin na zahtevo javno dostopni.
This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter and in particular human dignity, the integrity of the person, the protection of personal data, the freedom of art and science, the freedom to conduct business and the right to property.
Ta uredba spoštuje temeljne pravice in upošteva načela, ki jih priznava zlasti Listina, med njimi zlasti človekovo dostojanstvo, pravico do osebne celovitosti, varstvo osebnih podatkov, svobodo umetnosti in znanosti, svobodo poslovanja in lastninsko pravico.
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 [26].
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 [26].
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.
Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council [27].
Ta pooblastila bi bilo treba izvajati v skladu z Uredbo (EU) št. 182/2011 Evropskega parlamenta in Sveta [27].
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 clinical 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 klinični 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.
The Commission should adopt immediately applicable implementing acts where, in duly justified cases relating to the extension to the territory of the Union of a national derogation from the applicable conformity assessment procedures, imperative grounds of urgency so require.
Komisija bi morala sprejeti izvedbene akte, ki se začnejo uporabljati takoj, kadar je to potrebno iz ustrezno nujnih razlogov v ustrezno utemeljenih primerih v zvezi z razširitvijo nacionalnega odstopanja od postopkov ugotavljanja skladnosti na celotno ozemlje Unije.
In order to enable it to designate issuing entities, expert panels and expert laboratories, implementing powers should be conferred on the Commission.
Na Komisijo bi bilo treba prenesti izvedbena pooblastila, da bi lahko imenovala subjekte za izdajanje, strokovne odbore in strokovne laboratorije.
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 medical 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 medicinskih 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 Directives 90/385/EEC and 93/42/EEC and to their capacity to continue issuing valid certificates under those two Directives 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 direktivama 90/385/ES in 93/42/EGS, ter v njihovo zmožnost, da do datuma začetka uporabe te uredbe še naprej izdajajo veljavne certifikate v skladu z navedenima direktivama.
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 Directives 90/385/EEC and 93/42/EEC should remain in force.
V tem prehodnem obdobju bi se morale še naprej uporabljati nekatere določbe iz direktiv 90/385/EGS in 93/42/EGS.
However, in order to avoid multiple registrations, economic operators and notified bodies who register in the relevant electronic systems set up at Union level pursuant to this Regulation should be considered to be in compliance with the registration requirements adopted by the Member States pursuant to those provisions.
Za preprečitev podvajanja registracij pa bi se moralo za gospodarske subjekte in priglašene organe, ki se registrirajo v ustreznih elektronskih sistemih, vzpostavljenih na ravni Unije na podlagi te uredbe, šteti, da izpolnjujejo zahteve v zvezi z registracijo, ki so jih v skladu z navedenimi določbami sprejele države članice.
In order to provide for a smooth introduction of the UDI system, the moment of application of the obligation to place the UDI carrier on the label of the device should vary from one to five years after the date of application of this Regulation depending upon the class of the device concerned.
Za zagotovitev nemotene uvedbe sistema UDI bi moral biti datum začetka uporabe obveznosti navedbe zapisa UDI na oznaki pripomočka različen, in sicer od enega leta do pet let po datumu začetka uporabe te uredbe, odvisno od razreda zadevnega pripomočka.
Directives 90/385/EEC and 93/42/EEC should be repealed to ensure that only one set of rules applies to the placing of medical devices on the market and the related aspects covered by this Regulation.
Direktivi 90/385/EGS in 93/42/EGS bi bilo treba razveljaviti za zagotovitev, da se za dajanje medicinskih pripomočkov na trg in s tem povezane vidike, ki jih zajema ta uredba, uporablja le en sklop pravil.
Manufacturers' obligations as regards the making available of documentation regarding devices they placed on the market and manufacturers' and Member States' obligations as regards vigilance activities for devices placed on the market pursuant to those Directives should however continue to apply.
Še naprej pa bi se morale uporabljati obveznosti proizvajalcev v zvezi z omogočanjem dostopnosti dokumentacije o pripomočkih, ki so jih dali na trg, ter obveznosti držav članic v zvezi z dejavnostmi vigilance za pripomočke, dane na trg v skladu z navedenima direktivama.
While it should be left to Member States to decide how to organise vigilance activities, it is desirable for them to have the possibility of reporting incidents related to devices placed on the market pursuant to the Directives using the same tools as those for reporting on devices placed on the market pursuant to this Regulation.
Čeprav bi bilo treba državam članicam prepustiti, da odločijo, kako bodo organizirale dejavnosti vigilance, je zaželeno, da bi imele možnost poročati o zapletih v zvezi s pripomočki, danimi na trg v skladu z navedenima direktivama, s pomočjo enakih orodij, kot se uporabljajo za poročanje v zvezi s pripomočki, danimi na trg na podlagi te uredbe.
It is furthermore appropriate, in order to ensure a smooth transition from the old regime to the new regime, to provide that Commission Regulation (EU) No 207/2012 [28] and Commission Regulation (EU) No 722/2012 [29] should remain in force and continue to apply unless and until repealed by implementing acts adopted by the Commission pursuant to this Regulation.
Za zagotovitev nemotenega prehoda s stare na novo ureditev je ustrezno tudi določiti, da bi Uredba Komisije (EU) št. 207/2012 [28] in Uredba Komisije (EU) št. 722/2012 [29] ostali v veljavi in se uporabljali vse do morebitne razveljavitve z izvedbenimi akti, ki jih Komisija sprejme v skladu s to uredbo.
Decision 2010/227/EU adopted in implementation of those Directives and Directive 98/79/EC should also remain in force and continue to apply until the date when Eudamed becomes fully functional.
Tudi Sklep 2010/227/EU, sprejet za izvajanje navedenih direktiv in Direktive 98/79/ES, bi moral ostati v veljavi in se uporabljati do datuma, na katerega bo Eudamed začel delovati v celoti.
Conversely, no such maintenance in force is required for Commission Directives 2003/12/EC [30] and 2005/50/EC [31] and Commission Implementing Regulation (EU) No 920/2013 [32].(99) The requirements of this Regulation should be applicable to all devices placed on the market or put into service from the date of application of this Regulation.
Nasprotno pa se ohranitev veljavnosti ne zahteva za direktivi Komisije 2003/12/ES [30] in 2005/50/ES [31] ter Izvedbeno uredbo Komisije (EU) št. 920/2013 [32].(99) Zahteve, določene v tej uredbi, bi se morale uporabljati za vse pripomočke, ki se dajo na trg ali v uporabo od datuma začetka uporabe te uredbe.
However, in order to provide for a smooth transition it should be possible, for a limited period of time from that date, for devices to be placed on the market or put into service by virtue of a valid certificate issued pursuant to Directive 90/385/EEC or pursuant to Directive 93/42/EEC.
Da pa bi zagotovili nemoten prehod, bi v omejenem obdobju po tem datumu morali omogočiti, da se pripomočki dajejo na trg ali v uporabo na podlagi certifikatov, izdanih v skladu z Direktivo 90/385/EGS ali v skladu z Direktivo 93/42/EGS.
The European Data Protection Supervisor has given an opinion [33] pursuant to Article 28(2) of Regulation (EC) No 45/2001.
Evropski nadzornik za varstvo podatkov je podal mnenje [33] v skladu s členom 28(2) Uredbe (ES) št. 45/2001.
Since the objectives of this Regulation, namely to ensure the smooth functioning of the internal market as regards medical devices and to ensure high standards of quality and safety for medical devices, thus ensuring a high level of protection of health and safety of patients, users and other persons, cannot be sufficiently achieved by the Member States but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union.
Ker ciljev te uredbe države članice ne morejo zadovoljivo doseči, in sicer zagotoviti nemoteno delovanje notranjega trga za medicinske pripomočke ter visokih standardov kakovosti in varnosti medicinskih pripomočkov ter hkrati visoko raven varovanja zdravja in varnosti pacientov, uporabnikov in drugih oseb, temveč se zaradi obsega in učinkov ukrepa lažje dosežejo na ravni Unije, lahko Unija sprejme ukrepe v skladu z načelom subsidiarnosti iz člena 5 Pogodbe o Evropski uniji.
In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives,
V skladu z načelom sorazmernosti iz navedenega člena ta uredba ne presega tistega, kar je potrebno za doseganje navedenih ciljev –
This Regulation lays down rules concerning the placing on the market, making available on the market or putting into service of medical devices for human use and accessories for such devices in the Union.
Ta uredba določa pravila za dajanje na trg medicinskih pripomočkov za uporabo v humani medicini in njihovih dodatkov, omogočanje njihove dostopnosti na trgu ali njihovo dajanje v uporabo v Uniji.
This Regulation also applies to clinical investigations concerning such medical devices and accessories conducted in the Union.
Ta uredba se uporablja tudi za klinične raziskave glede teh medicinskih pripomočkov in dodatkov, ki se izvajajo v Uniji.
This Regulation shall also apply, as from the date of application of common specifications adopted pursuant to Article 9, to the groups of products without an intended medical purpose that are listed in Annex XVI, taking into account the state of the art, and in particular existing harmonised standards for analogous devices with a medical purpose, based on similar technology.
Ta uredba se od datuma začetka uporabe skupnih specifikacij, sprejetih v skladu s členom 9, uporablja tudi za skupine izdelkov brez predvidenega medicinskega namena iz Priloge XVI, ob upoštevanju najnovejšega tehnološkega razvoja in zlasti obstoječih harmoniziranih standardov za analogne pripomočke z medicinskim se namenom, ki temeljijo na podobni tehnologiji.
The common specifications for each of the groups of products listed in Annex XVI shall address, at least, application of risk management as set out in Annex I for the group of products in question and, where necessary, clinical evaluation regarding safety.
Skupne specifikacije za vsako skupino izdelkov iz Priloge XVI zadevajo najmanj uporabo obvladovanja tveganja, kot je za zadevno skupino izdelkov določeno v Prilogi I, ter po potrebi klinično oceno varnosti.
They shall apply as from six months after the date of their entry into force or from 26 May 2020, whichever is the latest.
Ta uredba se uporablja tudi za klinične raziskave v zvezi z izdelki iz prvega pododstavka, opravljene v Uniji.
Notwithstanding Article 122, Member States' measures regarding the qualification of the products covered by Annex XVI as medical devices pursuant to Directive 93/42/EEC shall remain valid until the date of application, as referred to in the first subparagraph, of the relevant common specifications for that group of products.
Pripomočki, predvideni za uporabo v medicinske in tudi nemedicinske namene, morajo kumulativno izpolnjevati zahteve, ki veljajo za pripomočke s predvidenim medicinskim namenom, in tiste, ki veljajo za pripomočke brez predvidenega medicinskega namena.
This Regulation also applies to clinical investigations conducted in the Union concerning the products referred to in the first subparagraph.
Medicinski pripomočki, dodatki za medicinske pripomočke in izdelki iz Priloge XVI, za katere se v skladu z odstavkom 2 uporablja ta uredba, se za namene te uredbe imenujejo „pripomočki“.
Devices with both a medical and a non-medical intended purpose shall fulfil cumulatively the requirements applicable to devices with an intended medical purpose and those applicable to devices without an intended medical purpose.
Kadar je to upravičeno na podlagi podobnosti med značilnostmi in tveganji pripomočka s predvidenim medicinskim namenom, danim na trg, in izdelka brez predvidenega medicinskega namena, se na Komisijo prenese pooblastilo za sprejemanje delegiranih aktov v skladu s členom 115, da zaradi varovanja zdravja in varnosti pacientov, uporabnikov ali drugih oseb ali drugih vidikov javnega zdravja spremeni seznam iz Priloge XVI, tako da nanj doda nove skupine izdelkov.
For the purposes of this Regulation, medical devices, accessories for medical devices, and products listed in Annex XVI to which this Regulation applies pursuant to paragraph 2 shall hereinafter be referred to as ‘devices’.
Ta uredba se ne uporablja za:
Where justified on account of the similarity between a device with an intended medical purpose placed on the market and a product without an intended medical purpose in respect of their characteristics and risks, the Commission is empowered to adopt delegated acts in accordance with Article 115 to amend the list in Annex XVI, by adding new groups of products, in order to protect the health and safety of users or other persons or other aspects of public health.
in vitro diagnostične medicinske pripomočke, ki jih zajema Uredba (EU) 2017/746;
This Regulation does not apply to:
zdravila, kot so opredeljena v točki 2 člena 1 Direktive 2001/83/ES.
in vitro diagnostic medical devices covered by Regulation (EU) 2017/746;
Pri odločanju, ali izdelek ureja Direktiva 2001/83/ES ali ta uredba, se upošteva zlasti glavni način delovanja izdelka;
medicinal products as defined in point 2 of Article 1 of Directive 2001/83/EC.
zdravila za napredno zdravljenje, ki jih zajema Uredba (ES) št. 1394/2007;
In deciding whether a product falls under Directive 2001/83/EC or under this Regulation, particular account shall be taken of the principal mode of action of the product;
človeško kri, izdelke iz človeške krvi, plazmo ali krvne celice človeškega izvora ali pripomočke, ki ob dajanju na trg ali v uporabo vsebujejo take izdelke iz krvi, plazmo ali celice, razen pripomočkov iz odstavka 8 tega člena;