natgillin/translations-raw huggingface dataset:
Since in some cases it is difficult to distinguish between medical devices and cosmetic products, the possibility of taking a Union-wide decision regarding the regulatory status of a product should also be introduced in Regulation (EC) No 1223/2009 of the European Parliament and of the Council [6].
Ker je v nekaterih primerih težko razlikovati med medicinskimi pripomočki in kozmetičnimi izdelki, bi bilo treba v Uredbo (ES) št. 1223/2009 Evropskega parlamenta in Sveta [6] vključiti možnost, da se na ravni Unije sprejme odločitev o regulativnem statusu izdelka.
Products which combine a medicinal product or substance and a medical device are regulated either under this Regulation or under Directive 2001/83/EC of the European Parliament and of the Council.
Izdelke, ki združujejo zdravilo ali zdravilno snov in medicinski pripomoček, ureja bodisi ta uredba bodisi Direktiva 2001/83/ES Evropskega parlamenta in Sveta [7].
The two legislative acts should ensure appropriate interaction in terms of consultations during pre-market assessment, and of exchange of information in the context of vigilance activities involving such combination products.
Z obema zakonodajnima aktoma bi morali zagotoviti ustrezno sodelovanje v obliki posvetovanj med ocenjevanjem pred dajanjem na trg ter izmenjave informacij v okviru dejavnosti vigilance teh kombiniranih izdelkov.
For medicinal products that integrate a medical device part, compliance with the general safety and performance requirements laid down in this Regulation for the device part should be adequately assessed in the context of the marketing authorisation for such medicinal products.
Pri zdravilih, v katera je vključen del medicinskega pripomočka, bi bilo treba v postopku za izdajo dovoljenja za promet za ta zdravila ustrezno oceniti, ali ta del pripomočka izpolnjuje splošne zahteve glede varnosti in učinkovitosti, določene v tej uredbi.
Directive 2001/83/EC should therefore be amended.
Direktivo 2001/83/ES bi bilo zato treba spremeniti.
Union legislation, in particular Regulation (EC) No 1394/2007 of the European Parliament and of the Council [8] and Directive 2004/23/EC of the European Parliament and of the Council [9], is incomplete in respect of certain products manufactured utilising derivatives of tissues or cells of human origin that are non-viable or are rendered non-viable.
Zakonodaja Unije, zlasti Uredba (ES) št. 1394/2007 Evropskega parlamenta in Sveta [8] ter Direktiva 2004/23/ES Evropskega parlamenta in Sveta [9], je nepopolna, saj ne vključuje nekaterih izdelkov, izdelanih z uporabo derivatov človeških tkiv ali celic, ki so neviabilni ali so postali neviabilni.
Such products should come under the scope of this Regulation, provided they comply with the definition of a medical device or are covered by this Regulation.
Takšni izdelki bi morali biti vključeni v področje uporabe te uredbe, če ustrezajo opredelitvi medicinskega pripomočka ali so zajeti s to uredbo.
Certain groups of products for which a manufacturer claims only an aesthetic or another non-medical purpose but which are similar to medical devices in terms of functioning and risks profile should be covered by this Regulation.
Ta uredba bi morala zajemati nekatere skupine izdelkov, za katere proizvajalec trdi, da se uporabljajo le v estetske ali druge nemedicinske namene, vendar so, kar zadeva njihovo delovanje in profil tveganja, podobni medicinskim pripomočkom.
In order for manufacturers to be able to demonstrate the conformity of such products, the Commission should adopt common specifications at least with regard to application of risk management and, where necessary, clinical evaluation regarding safety.
Da bi proizvajalci lahko dokazali skladnost takšnih izdelkov, bi morala Komisija sprejeti skupne specifikacije vsaj za uporabo obvladovanja tveganja in po potrebi klinično oceno varnosti.
Such common specifications should be developed specifically for a group of products without an intended medical purpose and should not be used for conformity assessment of the analogous devices with a medical purpose.
Te skupne specifikacije bi bilo treba pripraviti posebej za skupino izdelkov brez predvidenega medicinskega namena in se ne bi smele uporabljati za ugotavljanje skladnosti analognih pripomočkov z medicinskim namenom.
Devices with both a medical and a non-medical intended purpose should fulfil both the requirements applicable to devices with, and to devices without, an intended medical purpose.
Pripomočki s predvidenim medicinskim in nemedicinskim namenom bi morali izpolnjevati tako zahteve, ki veljajo za pripomočke s predvidenim medicinskim namenom, kot tiste, ki veljajo za pripomočke brez predvidenega medicinskega namena.
As is the case for products that contain viable tissues or cells of human or animal origin, that are explicitly excluded from Directives 90/385/EEC and 93/42/EEC and hence from this Regulation, it should be clarified that products that contain or consist of viable biological materials or viable organisms of another origin in order to achieve or support the intended purpose of those products are not covered by this Regulation either.
Kot je to v primeru izdelkov, ki vsebujejo viabilna tkiva ali celice človeškega ali živalskega izvora in so izrecno izključeni iz področja uporabe direktiv 90/385/EGS in 93/42/EGS ter tako tudi iz te uredbe, bi bilo treba tudi za izdelke, ki vsebujejo viabilne biološke materiale ali viabilne organizme – ali so iz njih sestavljeni –, ki niso človeškega ali živalskega izvora in so namenjeni doseganju ali podpori predvidenega namena teh izdelkov, pojasniti, da niso zajeti v tej uredbi.
The requirements laid down in Directive 2002/98/EC of the European Parliament and of the Council [10] should continue to apply.
Zahteve, določene v Direktivi 2002/98/ES Evropskega parlamenta in Sveta [10], bi se morale uporabljati še naprej.
There is scientific uncertainty about the risks and benefits of nanomaterials used for devices.
Tveganj in koristi, povezanih z nanomateriali, ki se uporabljajo v pripomočkih, še ni mogoče potrditi z znanstveno gotovostjo.
In order to ensure a high level of health protection, free movement of goods and legal certainty for manufacturers, it is necessary to introduce a uniform definition for nanomaterials based on Commission Recommendation 2011/696/EU [11], with the necessary flexibility to adapt that definition to scientific and technical progress and subsequent regulatory development at Union and international level.
Za zagotovitev visoke ravni varovanja zdravja, prostega pretoka blaga in pravne varnosti za proizvajalce je treba uvesti enotno opredelitev nanomaterialov, temelječo na Priporočilu Komisije 2011/696/EU [11], ki bo dovolj prožna, da jo bo mogoče prilagajati znanstvenemu in tehničnemu napredku ter nadaljnjemu regulativnemu razvoju na ravni Unije in mednarodni ravni.
In the design and manufacture of devices, manufacturers should take special care when using nanoparticles for which there is a high or medium potential for internal exposure.
Pri zasnovi in izdelavi pripomočkov bi morali biti proizvajalci zlasti pozorni na nanodelce, pri katerih obstaja visoka ali srednja verjetnost za notranjo izpostavljenost.
Such devices should be subject to the most stringent conformity assessment procedures.
Za te pripomočke bi se morali uporabljati najstrožji postopki ugotavljanja skladnosti.
In preparation of implementing acts regulating the practical and uniform application of the corresponding requirements laid down in this Regulation, the relevant scientific opinions of the relevant scientific committees should be taken into account.
Pri pripravi izvedbenih aktov, ki urejajo praktično in enotno uporabo ustreznih zahtev, določenih v tej uredbi, bi bilo treba upoštevati relevantno znanstveno mnenje zadevnih znanstvenih odborov.
Safety aspects addressed by Directive 2014/30/EU of the European Parliament and of the Council [12] are an integral part of the general safety and performance requirements laid down in this Regulation for devices.
Varnostni vidiki iz Direktive 2014/30/ES Evropskega parlamenta in Sveta [12] so sestavni del splošnih zahtev glede varnosti in učinkovitosti pripomočkov, določenih v tej uredbi.
Consequently, this Regulation should be considered a lex specialis in relation to that Directive.
Zato bi bilo treba to uredbo obravnavati kot lex specialis glede na navedeno direktivo.
This Regulation should include requirements regarding the design and manufacture of devices emitting ionizing radiation without affecting the application of Council Directive 2013/59/Euratom [13] which pursues other objectives.
V to uredbo bi morali vključiti zahteve glede zasnove in izdelave pripomočkov, ki oddajajo ionizirajoče sevanje, ne da bi to vplivalo na uporabo Direktive Sveta 2013/59/Euratom [13], ki ima drugačne cilje.
This Regulation should include requirements for devices' design, safety and performance characteristics which are developed in such a way as to prevent occupational injuries, including protection from radiation.
V to uredbo bi morali vključiti zahteve glede zasnove, varnosti in učinkovitosti pripomočkov, ki so razviti tako, da se preprečijo poškodbe pri delu, kar vključuje zaščito pred sevanjem.
It is necessary to clarify that software in its own right, when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device, qualifies as a medical device, while software for general purposes, even when used in a healthcare setting, or software intended for life-style and well-being purposes is not a medical device.
Pojasniti je treba, da programska oprema sama, kadar jo proizvajalec posebej nameni za uporabo za enega ali več medicinskih namenov iz opredelitve medicinskega pripomočka, šteje za medicinski pripomoček, medtem ko programska oprema za splošne namene, tudi kadar se uporablja v zdravstvu, ali programska oprema za omogočanje določenega življenjskega sloga in dobrega počutja ne šteje za medicinski pripomoček.
The qualification of software, either as a device or an accessory, is independent of the software's location or the type of interconnection between the software and a device.
Na opredelitev, ali je programska oprema pripomoček ali dodatek, ne vpliva niti lokacija programske opreme niti vrsta povezave med programsko opremo in pripomočkom.
The definitions in this Regulation, regarding devices themselves, the making available of devices, economic operators, users and specific processes, the conformity assessment, clinical investigations and clinical evaluations, post-market surveillance, vigilance and market surveillance, standards and other technical specifications, should be aligned with well-established practice in the field at Union and international level in order to enhance legal certainty.
Zaradi večje pravne varnosti bi bilo treba opredelitve v tej uredbi, ki se nanašajo na pripomočke same, omogočanje dostopnosti pripomočkov, gospodarske subjekte, uporabnike in posebne postopke, ugotavljanje skladnosti, klinične raziskave in klinične ocene, nadzor po dajanju na trg, vigilanco in nadzor trga, standarde in druge tehnične specifikacije, uskladiti z uveljavljeno področno prakso na ravni Unije in mednarodni ravni.
It should be made clear that it is essential that devices offered to persons in the Union by means of information society services within the meaning of Directive (EU) 2015/1535 of the European Parliament and of the Council [14] and devices used in the context of a commercial activity to provide a diagnostic or therapeutic service to persons within the Union comply with the requirements of this Regulation, where the product in question is placed on the market or the service is provided in the Union.
Pojasniti bi bilo treba, da morajo pripomočki, ki so osebam v Uniji na voljo prek storitev informacijske družbe v smislu Direktive (EU) 2015/1535 Evropskega parlamenta in Sveta [14], in pripomočki, ki se uporabljajo pri komercialni dejavnosti, katerih namen je zagotovitev diagnostične ali terapevtske storitve osebam v Uniji, izpolnjevati zahteve iz te uredbe, ko se zadevni izdelek da na trg ali ko se storitev začne opravljati v Uniji.
To recognise the important role of standardisation in the field of medical devices, compliance with harmonised standards as defined in Regulation (EU) No 1025/2012 of the European Parliament and of the Council [15] should be a means for manufacturers to demonstrate conformity with the general safety and performance requirements and other legal requirements, such as those relating to quality and risk management, laid down in this Regulation.
Z izpolnjevanjem harmoniziranih standardov, opredeljenih v Uredbi (EU) št. 1025/2012 Evropskega parlamenta in Sveta [15], bi proizvajalci lahko dokazali, da izpolnjujejo splošne zahteve glede varnosti in učinkovitosti ter druge pravne zahteve, določene v tej uredbi, na primer tiste v zvezi s kakovostjo in obvladovanjem tveganja, s čimer bi se priznala pomembna vloga standardizacije na področju medicinskih pripomočkov.
Directive 98/79/EC of the European Parliament and of the Council [16] allows the Commission to adopt common technical specifications for specific categories of in vitro diagnostic medical devices.
Direktiva 98/79/ES Evropskega parlamenta in Sveta [16] Komisiji omogoča, da sprejme skupne tehnične specifikacije za posebne kategorije in vitro diagnostičnih medicinskih pripomočkov.
In areas where no harmonised standards exist or where they are insufficient, the Commission should be empowered to lay down common specifications which provide a means of complying with the general safety and performance requirements, and the requirements for clinical investigations and clinical evaluation and/or post-market clinical follow-up, laid down in this Regulation.
Na Komisijo bi bilo treba prenesti pooblastilo, da na področjih, kjer ni harmoniziranih standardov ali so ti nezadostni, določi skupne specifikacije za izpolnjevanje splošnih zahtev glede varnosti in učinkovitosti ter zahtev glede kliničnih raziskav in klinične ocene in/ali kliničnega spremljanja po dajanju na trg, ki so določene v tej uredbi.
Common specifications (‘CS’) should be developed after consulting the relevant stakeholders and taking account of European and international standards.
Skupne specifikacije bi morali pripraviti po posvetovanju z zadevnimi deležniki ter pri tej pripravi upoštevati evropske in mednarodne standarde.
The rules applicable to devices should be aligned, where appropriate, with the New Legislative Framework for the Marketing of Products, which consists of Regulation (EC) No 765/2008 of the European Parliament and of the Council [17] and Decision No 768/2008/EC of the European Parliament and of the Council [18].
Pravila, ki se uporabljajo za pripomočke, bi bilo treba, kjer je to ustrezno, uskladiti z novim zakonodajnim okvirom za trženje proizvodov, ki ga sestavljata Uredba (ES) št. 765/2008 Evropskega parlamenta in Sveta [17] in Sklep št. 768/2008/ES Evropskega parlamenta in Sveta [18].
The rules on Union market surveillance and control of products entering the Union market laid down in Regulation (EC) No 765/2008 apply to devices covered by this Regulation which does not prevent Member States from choosing the competent authorities to carry out those tasks.
Pravila za nadzor trga Unije in spremljanje izdelkov, ki vstopajo na trg Unije, določena v Uredbi (ES) št. 765/2008, se uporabljajo za pripomočke, ki jih zajema ta uredba, kar pa državam članicam ne preprečuje, da imenujejo organe, pristojne za izvajanje navedenih nalog.
It is appropriate to set out clearly the general obligations of the different economic operators, including importers and distributors, building on the New Legislative Framework for the Marketing of Products, without prejudice to the specific obligations laid down in the various parts of this Regulation, to enhance understanding of the requirements laid down in this Regulation and thus to improve regulatory compliance by the relevant operators.
Za lažje razumevanje zahtev, določenih v tej uredbi, in da bi tako zadevni gospodarski subjekti bolje izpolnjevali regulativne zahteve, je ustrezno jasno določiti splošne obveznosti različnih gospodarskih subjektov, vključno z uvozniki in distributerji, ki naj temeljijo na novem zakonodajnem okviru za trženje proizvodov in ne posegajo v posebne obveznosti, določene v različnih delih te uredbe.
For the purpose of this Regulation, the activities of distributors should be deemed to include acquisition, holding and supplying of devices.
V tej uredbi bi se moralo šteti, da dejavnosti distributerjev zajemajo pridobivanje, hrambo in dobavo pripomočkov.
Several of the obligations on manufacturers, such as clinical evaluation or vigilance reporting, that were set out only in the Annexes to Directives 90/385/EEC and 93/42/EEC, should be incorporated into the enacting provisions of this Regulation to facilitate its application.
Več obveznosti proizvajalcev, kot sta klinična ocena ali poročanje o vigilanci, ki so določene samo v prilogah k direktivama 90/385/EGS in 93/42/EGS, bi bilo treba vključiti v normativne določbe te uredbe, da bi se tako lahko lažje uporabljala.
Health institutions should have the possibility of manufacturing, modifying and using devices in-house and thereby address, on a non-industrial scale, the specific needs of target patient groups which cannot be met at the appropriate level of performance by an equivalent device available on the market.
Zdravstvene ustanove bi morale imeti možnost, da v sami ustanovi proizvajajo, spreminjajo in uporabljajo pripomočke in se tako na neindustrijski ravni odzovejo na posebne potrebe ciljnih skupin pacientov, ki jih ni mogoče dovolj učinkovito zadovoljiti z enakovrednim pripomočkom, dostopnim na trgu.
In that context, it is appropriate to provide that certain rules of this Regulation, as regards medical devices manufactured and used only within health institutions, including hospitals as well as institutions, such as laboratories and public health institutes that support the healthcare system and/or address patient needs, but which do not treat or care for patients directly, should not apply, since the aims of this Regulation would still be met in a proportionate manner.
V tem okviru je ustrezno določiti, da se nekatera pravila te uredbe ne uporabljajo v zvezi z medicinskimi pripomočki, ki se proizvajajo in uporabljajo le v zdravstvenih ustanovah, med katere spadajo bolnišnice in ustanove, kot so laboratoriji in javne zdravstvene ustanove, ki podpirajo zdravstveni sistem in/ali se odzivajo na potrebe pacientov, vendar ne zdravijo ali oskrbujejo pacientov neposredno, saj bodo cilji te uredbe kljub temu še vedno sorazmerno doseženi.
It should be noted that the concept of ‘health institution’ does not cover establishments primarily claiming to pursue health interests or healthy lifestyles, such as gyms, spas, wellness and fitness centres.
Poudariti je treba, da pojem „zdravstvena ustanova“ ne zajema subjektov, ki v prvi vrsti uresničujejo interese, povezane z zdravjem in zdravim načinom življenja, kot so telovadnice, zdravilišča, centri dobrega počutja in fitnes centri.
As a result, the exemption applicable to health institutions does not apply to such establishments.
Zato se izvzetje, ki se uporablja za zdravstvene ustanove, ne uporablja za navedene subjekte.
In view of the fact that natural or legal persons can claim compensation for damage caused by a defective device in accordance with applicable Union and national law, it is appropriate to require manufacturers to have measures in place to provide sufficient financial coverage in respect of their potential liability under Council Directive 85/374/EEC [19].
Ker lahko fizične ali pravne osebe v skladu z veljavnim pravom Unije in nacionalnim pravom zahtevajo nadomestilo za škodo, ki jo je povzročil pripomoček z napako, je ustrezno, da se od proizvajalcev zahteva sprejetje ukrepov za zagotovitev zadostnih finančnih sredstev za kritje njihove morebitne odgovornosti v skladu z Direktivo Sveta 85/374/EGS [19].
Such measures should be proportionate to the risk class, type of device and the size of the enterprise.
Takšni ukrepi bi morali biti sorazmerni z razredom tveganja, vrsto pripomočka in velikostjo podjetja.
In this context, it is also appropriate to lay down rules concerning the facilitation, by a competent authority, of the provision of information to persons who may have been injured by a defective device.
V tem smislu je tudi ustrezno, da se določijo pravila, ki pristojnemu organu nalagajo, da mora olajšati zagotavljanje informacij osebam, ki jih je poškodoval pripomoček z napako.
To ensure that devices manufactured in series production continue to be in conformity with the requirements of this Regulation and that experience from the use of the devices they manufacture is taken into account for the production process, all manufacturers should have a quality management system and a post-market surveillance system in place which should be proportionate to the risk class and the type of the device in question.
Za zagotovitev, da pripomočki, izdelani v serijski proizvodnji, ostanejo skladni z zahtevami te uredbe in da se izkušnje iz uporabe pripomočkov, ki jih proizvajajo, upoštevajo pri proizvodnem postopku, bi morali vsi proizvajalci imeti vzpostavljen sistem vodenja kakovosti ter sistem nadzora po dajanju na trg, ki bi morala biti sorazmerna z razredom tveganja in vrsto zadevnega pripomočka.
In addition, in order to minimize risks or prevent incidents related to devices, manufacturers should establish a system for risk management and a system for reporting of incidents and field safety corrective actions.
Proizvajalci bi tudi morali vzpostaviti sistem za obvladovanje tveganja ter sistem za poročanje o zapletih in varnostnih korektivnih ukrepih, da bi tako čim bolj zmanjšali tveganja ali preprečili zaplete v zvezi s pripomočki.
The risk management system should be carefully aligned with and reflected in the clinical evaluation for the device, including the clinical risks to be addressed as part of clinical investigations, clinical evaluation and post-market clinical follow up.
Sistem obvladovanja tveganja bi moral biti skrbno usklajen s klinično oceno pripomočka in v njej odražen, zajemati pa bi moral tudi klinična tveganja, ki se preučijo v okviru kliničnih raziskav, klinične ocene in kliničnega spremljanja po dajanju na trg.
The risk management and clinical evaluation processes should be inter-dependent and should be regularly updated.
Obvladovanje tveganja in klinična ocena bi morala biti medsebojno odvisna in bi ju bilo treba redno posodabljati.
It should be ensured that supervision and control of the manufacture of devices, and the post-market surveillance and vigilance activities concerning them, are carried out within the manufacturer's organisation by a person responsible for regulatory compliance who fulfils minimum conditions of qualification.
Zagotoviti bi bilo treba, da nadzor in kontrolo proizvodnje pripomočkov ter dejavnosti njihovega nadzora po dajanju na trg in dejavnosti vigilance v organizaciji proizvajalca izvaja oseba, ki je pristojna za skladnost z zakonodajo in izpolnjuje minimalne pogoje glede usposobljenosti.
For manufacturers who are not established in the Union, the authorised representative plays a pivotal role in ensuring the compliance of the devices produced by those manufacturers and in serving as their contact person established in the Union.
Pri proizvajalcih s sedežem zunaj Unije ima pooblaščeni predstavnik osrednjo vlogo pri zagotavljanju skladnosti pripomočkov, ki jih izdelajo ti proizvajalci, in je njihova kontaktna oseba s sedežem v Uniji.
Given that pivotal role, for the purposes of enforcement it is appropriate to make the authorised representative legally liable for defective devices in the event that a manufacturer established outside the Union has not complied with its general obligations.
Prav zaradi te osrednje vloge bi za namene izvrševanja bilo treba določiti, da ima pooblaščeni predstavnik pravno odgovornost za pripomočke z napako, kadar proizvajalec s sedežem zunaj Unije ne izpolnjuje svojih splošnih obveznosti.