natgillin/translations-raw huggingface dataset:
Importers shall keep a register of complaints, of non-conforming devices and of recalls and withdrawals, and provide the manufacturer, authorised representative and distributors with any information requested by them, in order to allow them to investigate complaints.
Uvozniki sodelujejo s proizvajalcem, proizvajalčevim pooblaščenim predstavnikom in pristojnimi organi, da bi zagotovili sprejetje potrebnih korektivnih ukrepov, na podlagi katerih bi pripomoček postal skladen ali bil umaknjen ali odpoklican s trga.
Importers who consider or have reason to believe that a device which they have placed on the market is not in conformity with this Regulation shall immediately inform the manufacturer and its authorised representative.
Če pripomoček pomeni resno tveganje, prav tako nemudoma obvestijo pristojne organe držav članic, v katerih je pripomoček dostopen, in, če je ustrezno, priglašeni organ, ki je izdal certifikat za zadevni pripomoček v skladu s členom 56, ter predložijo informacije, zlasti o neskladnosti in morebitnih sprejetih korektivnih ukrepih.
Importers shall co-operate with the manufacturer, the manufacturer's authorised representative and the competent authorities to ensure that the necessary corrective action to bring that device into conformity, to withdraw or recall it is taken.
Uvozniki, ki prejmejo pritožbe ali poročila zdravstvenih delavcev, pacientov ali uporabnikov o sumih na zaplete v zvezi s pripomočkom, ki so ga dali na trg, te informacije takoj sporočijo proizvajalcu in njegovemu pooblaščenemu predstavniku.
Where the device presents a serious risk, they shall also immediately inform the competent authorities of the Member States in which they made the device available and, if applicable, the notified body that issued a certificate in accordance with Article 56 for the device in question, giving details, in particular, of the non-compliance and of any corrective action taken.
Uvozniki v obdobju iz člena 10(8) hranijo izvod izjave EU o skladnosti in, kjer je potrebno, izvod ustreznega certifikata, vključno z morebitnimi spremembami in dopolnili, izdanimi v skladu s členom 56.
Importers who have received complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device which they have placed on the market shall immediately forward this information to the manufacturer and its authorised representative.
Uvozniki sodelujejo s pristojnimi organi na njihovo zahtevo pri kateri koli dejavnosti za odpravo ali – če to ni mogoče – zmanjšanje tveganj, povezanih s pripomočki, ki so jih dali na trg.
Importers shall, for the period referred to in Article 10(8), keep a copy of the EU declaration of conformity and, if applicable, a copy of any relevant certificate, including any amendments and supplements, issued in accordance with Article 56.
Uvozniki na zahtevo pristojnega organa države članice, v kateri ima uvoznik registrirani kraj poslovanja, zagotovijo brezplačne vzorce pripomočka ali, kadar to ni izvedljivo, omogočijo dostop do pripomočka.
Importers shall cooperate with competent authorities, at the latters' request, on any action taken to eliminate or, if that is not possible, mitigate the risks posed by devices which they have placed on the market.
Člen 14
Importers, upon request by a competent authority of the Member State in which the importer has its registered place of business, shall provide samples of the device free of charge or, where that is impracticable, grant access to the device.
Splošne obveznosti distributerjev
Article 14
Distributerji pri opravljanju svojih dejavnosti s potrebno skrbnostjo upoštevajo veljavne zahteve, ko omogočajo dostopnost pripomočka na trgu.
General obligations of distributors
Distributerji pred omogočanjem dostopnosti pripomočka na trgu preverijo, ali so izpolnjene vse naslednje zahteve:
When making a device available on the market, distributors shall, in the context of their activities, act with due care in relation to the requirements applicable.
pripomočku so priložene informacije, ki jih je predložil proizvajalec v skladu s členom 10(11);
Before making a device available on the market, distributors shall verify that all of the following requirements are met:
uvoznik je v zvezi z uvoženimi pripomočki izpolnil zahteve iz člena 13(3);
the device is accompanied by the information to be supplied by the manufacturer in accordance with Article 10(11);
proizvajalec je določil UDI, kjer je to ustrezno.
for imported devices, the importer has complied with the requirements set out in Article 13(3);
Distributer lahko za izpolnitev zahtev iz točk (a), (b) in (d) prvega pododstavka uporabi metodo vzorčenja, ki je reprezentativna za pripomočke, ki jih dobavlja.
that, where applicable, a UDI has been assigned by the manufacturer.
Če distributer meni ali utemeljeno domneva, da pripomoček ni skladen z zahtevami iz te uredbe, ne sme omogočiti, da bi bil dostopen na trgu, dokler ni skladen z zahtevami; o tem obvesti proizvajalca ter po potrebi pooblaščenega predstavnika proizvajalca in uvoznika.
In order to meet the requirements referred to in points (a), (b) and (d) of the first subparagraph the distributor may apply a sampling method that is representative of the devices supplied by that distributor.
Če distributer meni ali utemeljeno domneva, da pripomoček pomeni resno tveganje ali da je ponarejen, o tem obvesti tudi pristojni organ države članice, v kateri ima sedež.
Where a distributor considers or has reason to believe that a device is not in conformity with the requirements of this Regulation, it shall not make the device available on the market until it has been brought into conformity, and shall inform the manufacturer and, where applicable, the manufacturer's authorised representative, and the importer.
Distributerji zagotovijo, da so v času, ko so odgovorni za pripomoček, pogoji skladiščenja ali prevoza skladni s pogoji, ki jih je določil proizvajalec.
Where the distributor considers or has reason to believe that the device presents a serious risk or is a falsified device, it shall also inform the competent authority of the Member State in which it is established.
Distributerji, ki menijo ali utemeljeno domnevajo, da pripomoček, katerega dostopnost na trgu so omogočili, ni skladen s to uredbo, o tem nemudoma obvestijo proizvajalca in po potrebi pooblaščenega predstavnika proizvajalca in uvoznika.
Distributors shall ensure that, while the device is under their responsibility, storage or transport conditions comply with the conditions set by the manufacturer.
Distributerji sodelujejo s proizvajalcem ter po potrebi pooblaščenim predstavnikom proizvajalca in uvoznikom ter s pristojnimi organi, da bi zagotovili sprejetje potrebnih korektivnih ukrepov, na podlagi katerih bi pripomoček postal skladen ali bil umaknjen ali odpoklican s trga, kakor je ustrezno.
Distributors that consider or have reason to believe that a device which they have made available on the market is not in conformity with this Regulation shall immediately inform the manufacturer and, where applicable, the manufacturer's authorised representative and the importer.
Če distributer meni ali utemeljeno domneva, da pripomoček pomeni resno tveganje, o tem nemudoma obvesti tudi pristojne organe držav članic, v katerih je omogočil dostopnost pripomočka, ter navede podrobnosti, zlasti o neskladnosti in morebitnih sprejetih korektivnih ukrepih.
Distributors shall co-operate with the manufacturer and, where applicable, the manufacturer's authorised representative, and the importer, and with competent authorities to ensure that the necessary corrective action to bring that device into conformity, to withdraw or to recall it, as appropriate, is taken.
Distributerji, ki prejmejo pritožbe ali poročila zdravstvenih delavcev, pacientov ali uporabnikov o sumih na zaplete v zvezi s pripomočkom, katerega dostopnost so omogočili, te informacije takoj pošljejo proizvajalcu ter po potrebi pooblaščenemu predstavniku proizvajalca in uvozniku.
Where the distributor considers or has reason to believe that the device presents a serious risk, it shall also immediately inform the competent authorities of the Member States in which it made the device available, giving details, in particular, of the non-compliance and of any corrective action taken.
Vodijo register pritožb, neskladnih, odpoklicanih in umaknjenih pripomočkov ter proizvajalca ter po potrebi pooblaščenega predstavnika in uvoznika obveščajo o takšnem spremljanju ter jim na zahtevo sporočajo vse informacije.
Distributors that have received complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device they have made available, shall immediately forward this information to the manufacturer and, where applicable, the manufacturer's authorised representative, and the importer.
Distributerji pristojnemu organu na njegovo zahtevo posredujejo vse razpoložljive informacije in dokumentacijo, ki so potrebne, da dokažejo skladnost pripomočka.
They shall keep a register of complaints, of non-conforming devices and of recalls and withdrawals, and keep the manufacturer and, where available, the authorised representative and the importer informed of such monitoring and provide them with any information upon their request.
Šteje se, da so distributerji izpolnili obveznost iz prvega pododstavka, ko proizvajalec ali, kadar je to ustrezno, pooblaščeni predstavnik za zadevni pripomoček posreduje zahtevane informacije.
Distributors shall, upon request by a competent authority, provide it with all the information and documentation that is at their disposal and is necessary to demonstrate the conformity of a device.
Distributerji sodelujejo s pristojnimi organi na njihovo zahtevo pri vsaki dejavnosti za odpravo tveganj, povezanih s pripomočki, katerih dostopnost na trgu so omogočili.
Distributors shall be considered to have fulfilled the obligation referred to in the first subparagraph when the manufacturer or, where applicable, the authorised representative for the device in question provides the required information.
Distributerji na zahtevo pristojnega organa zagotovijo brezplačne vzorce pripomočka ali, kadar to ni izvedljivo, omogočijo dostop do pripomočka.
Distributors shall cooperate with competent authorities, at their request, on any action taken to eliminate the risks posed by devices which they have made available on the market.
Člen 15
Distributors, upon request by a competent authority, shall provide free samples of the device or, where that is impracticable, grant access to the device.
Oseba, odgovorna za skladnost z zakonodajo
Article 15
Proizvajalci imajo v svoji organizaciji vsaj eno osebo, ki je odgovorna za skladnost z zakonodajo in ima potrebno strokovno znanje na področju medicinskih pripomočkov.
Person responsible for regulatory compliance
Potrebno strokovno znanje se dokaže z eno od naslednjih kvalifikacij:
Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices.
diploma, spričevalo ali drugo dokazilo o formalnih kvalifikacijah, ki se podeljuje ob zaključku univerzitetnega izobraževanja ali študijskega programa, ki ga zadevna država članica priznava za enakovrednega na področju prava, medicine, farmacije, inženirstva ali druge ustrezne znanstvene vede, ter vsaj eno leto delovnih izkušenj z zakonodajnimi zadevami ali s sistemi vodenja kakovosti, povezanimi z medicinskimi pripomočki;
The requisite expertise shall be demonstrated by either of the following qualifications:
štiri leta poklicnih izkušenj z zakonodajnimi zadevami ali s sistemi vodenja kakovosti, povezanimi z medicinskimi pripomočki.
a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices;
Brez poseganja v nacionalne določbe glede poklicnih kvalifikacij lahko proizvajalci pripomočkov, izdelanih za posameznega uporabnika, potrebno strokovno znanje iz prvega pododstavka dokažejo z vsaj dvema letoma poklicnih izkušenj na ustreznem proizvodnem področju.
four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
Mikro in malim podjetjem v smislu Priporočila Komisije 2003/361/ES [36] znotraj organizacije ni treba imeti osebe, odgovorne za skladnost z zakonodajo, vendar pa jim mora biti takšna oseba stalno in nepretrgoma na voljo.
Without prejudice to national provisions regarding professional qualifications, manufacturers of custom-made devices may demonstrate the requisite expertise referred to in the first subparagraph by having at least two years of professional experience within a relevant field of manufacturing.
Oseba, odgovorna za skladnost z zakonodajo, je odgovorna vsaj za zagotavljanje, da:
Micro and small enterprises within the meaning of Commission Recommendation 2003/361/EC [36] shall not be required to have the person responsible for regulatory compliance within their organisation but shall have such person permanently and continuously at their disposal.
je skladnost pripomočkov ustrezno preverjena v skladu s sistemom vodenja kakovosti, v okviru katerega so bili pripomočki izdelani, preden se pripomoček sprosti;
The person responsible for regulatory compliance shall at least be responsible for ensuring that:
sta tehnična dokumentacija in izjava EU o skladnosti sestavljeni in se redno posodabljata;
the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;
so obveznosti glede nadzora po dajanju na trg izpolnjene v skladu s členom 10(10);
the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
so obveznosti poročanja iz členov od 87 do 91 izpolnjene;
the post-market surveillance obligations are complied with in accordance with Article 10(10);
je pri pripomočkih, ki so predmet raziskave, izdana izjava iz oddelka 4.1 poglavja II Priloge XV.
the reporting obligations referred to in Articles 87 to 91 are fulfilled;
Če je za skladnost z zakonodajo v skladu z odstavki 1, 2 in 3 soodgovornih več oseb, se zapišejo področja, za katera je posamezna oseba odgovorna.
in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.
Oseba, odgovorna za skladnost z zakonodajo, ne sme utrpeti nobenih negativnih posledic v zvezi s pravilnim izpolnjevanjem svojih dolžnosti v proizvajalčevi organizaciji, ne glede na to, ali je zaposlena v organizaciji ali ne.
If a number of persons are jointly responsible for regulatory compliance in accordance with paragraphs 1, 2 and 3, their respective areas of responsibility shall be stipulated in writing.
Pooblaščenim predstavnikom je stalno in nepretrgoma na voljo vsaj ena oseba, pristojna za skladnost z zakonodajo, ki ima potrebno strokovno znanje na področju regulativnih zahtev za medicinske pripomočke v Uniji.
The person responsible for regulatory compliance shall suffer no disadvantage within the manufacturer's organisation in relation to the proper fulfilment of his or her duties, regardless of whether or not they are employees of the organisation.
Člen 16
Authorised representatives shall have permanently and continuously at their disposal at least one person responsible for regulatory compliance who possesses the requisite expertise regarding the regulatory requirements for medical devices in the Union.
Primeri, v katerih se obveznosti proizvajalcev uporabljajo za uvoznike, distributerje in druge osebe
Article 16
Distributer, uvoznik ali druga fizična ali pravna oseba prevzame obveznosti proizvajalcev, če stori kar koli od naslednjega:
Cases in which obligations of manufacturers apply to importers, distributors or other persons
omogoči dostopnosti pripomočka na trgu pod svojim imenom, registriranim trgovskim imenom ali registrirano blagovno znamko, razen v primerih, ko distributer ali uvoznik sklene dogovor s proizvajalcem, v skladu s katerim je proizvajalec kot tak naveden na oznaki in je odgovoren za izpolnjevanje zahtev, ki jih ta uredba nalaga proizvajalcem;
A distributor, importer or other natural or legal person shall assume the obligations incumbent on manufacturers if it does any of the following:
spremeni predvideni namena pripomočka, ki je že dan na trg ali v uporabo;
makes available on the market a device under its name, registered trade name or registered trade mark, except in cases where a distributor or importer enters into an agreement with a manufacturer whereby the manufacturer is identified as such on the label and is responsible for meeting the requirements placed on manufacturers in this Regulation;
spremeni pripomočka, ki je že dan na trg ali v uporabo tako, da to lahko vpliva na skladnost z veljavnimi zahtevami.
changes the intended purpose of a device already placed on the market or put into service;
Prvi pododstavek se ne uporablja za osebe, ki se sicer ne štejejo za proizvajalca, kakor je opredeljen v točki 30 člena 2, vendar za posameznega pacienta sestavljajo ali prilagajajo pripomoček, ki je že na trgu, ne da bi spreminjale njegov predvideni namen.
modifies a device already placed on the market or put into service in such a way that compliance with the applicable requirements may be affected.
Za namene točke (c) odstavka 1 se kot sprememba pripomočka, ki bi lahko vplivala na skladnost z veljavnimi zahtevami, ne štejejo:
The first subparagraph shall not apply to any person who, while not considered a manufacturer as defined in point (30) of Article 2, assembles or adapts for an individual patient a device already on the market without changing its intended purpose.
zagotavljanje in prevod informacij, ki jih proizvajalec zagotovi v skladu z oddelkom 23 Priloge I in se nanašajo na pripomoček, ki je že dan na trg, ter dodatnih informacij, ki so potrebne za trženje pripomočka v zadevni državi članici;
For the purposes of point (c) of paragraph 1, the following shall not be considered to be a modification of a device that could affect its compliance with the applicable requirements:
spremembe zunanje embalaže pripomočka, ki je že dan na trg, vključno s spremembo velikosti pakiranja, če je prepakiranje potrebno, da se pripomoček trži v zadevni državi članici, in če je to izvedeno v takšnih pogojih, da ne more vplivati na prvotno stanje pripomočka.
provision, including translation, of the information supplied by the manufacturer, in accordance with Section 23 of Annex I, relating to a device already placed on the market and of further information which is necessary in order to market the device in the relevant Member State;
Za pripomočke, dane na trg v sterilnem stanju, se domneva, da niso več v želenem prvotnem stanju, če je pakiranje, ki je potrebno za ohranjanje sterilnosti, zaradi prepakiranja odprto, poškodovano ali drugače prizadeto.
changes to the outer packaging of a device already placed on the market, including a change of pack size, if the repackaging is necessary in order to market the device in the relevant Member State and if it is carried out in such conditions that the original condition of the device cannot be affected by it.
Distributer ali uvoznik, ki izvaja dejavnosti iz točk (a) in (b) odstavka 2, na pripomočku ali, če to ni izvedljivo, na embalaži ali v priloženem dokumentu navede dejavnosti, ki se izvajajo, ter svoje ime, registrirano trgovsko ime ali registrirano blagovno znamko, registrirani kraj poslovanja in naslov, na katerem je dosegljiv, tako da je mogoče ugotoviti naslov njegove dejanske lokacije.
In the case of devices placed on the market in sterile condition, it shall be presumed that the original condition of the device is adversely affected if the packaging that is necessary for maintaining the sterile condition is opened, damaged or otherwise negatively affected by the repackaging.
Distributerji in uvozniki zagotovijo, da je vzpostavljen sistem vodenja kakovosti, ki vključuje postopke za zagotavljanje, da je prevod informacij natančen in redno posodobljen, da se dejavnosti iz točk (a) in (b) odstavka 2 izvajajo na način in pod pogoji, ki ohranjajo prvotno stanje pripomočka in da embalaža prepakiranega pripomočka nima napak ter da ni slabe kakovosti ali neurejena.
A distributor or importer that carries out any of the activities mentioned in points (a) and (b) of paragraph 2 shall indicate on the device or, where that is impracticable, on its packaging or in a document accompanying the device, the activity carried out together with its name, registered trade name or registered trade mark, registered place of business and the address at which it can be contacted, so that its location can be established.
Sistem vodenja kakovosti med drugim zajema postopke za zagotavljanje, da je distributer ali uvoznik obveščen o kakršnih koli korektivnih ukrepih, ki jih proizvajalec sprejme v zvezi z zadevnim pripomočkom za obravnavo vprašanj o varnosti ali zagotavljanje skladnosti pripomočka s to uredbo.
Distributors and importers shall ensure that they have in place a quality management system that includes procedures which ensure that the translation of information is accurate and up-to-date, and that the activities mentioned in points (a) and (b) of paragraph 2 are performed by a means and under conditions that preserve the original condition of the device and that the packaging of the repackaged device is not defective, of poor quality or untidy.
Vsaj 28 dni, preden je na novo označen ali prepakiran pripomoček dostopen na trgu, distributerji ali uvozniki, ki izvajajo katere koli od dejavnosti iz točk (a) in (b) odstavka 2, obvestijo proizvajalca in pristojni organ države članice, v kateri nameravajo omogočiti dostopnost pripomočka, o nameri omogočiti dostopnost na novo označenega ali prepakiranega pripomočka ter proizvajalcu in pristojnemu organu na zahtevo predložijo vzorec ali maketo na novo označenega ali prepakiranega pripomočka, vključno z vsemi prevedenimi oznakami in navodili za uporabo.
The quality management system shall cover, inter alia, procedures ensuring that the distributor or importer is informed of any corrective action taken by the manufacturer in relation to the device in question in order to respond to safety issues or to bring it into conformity with this Regulation.
V istem obdobju 28 dni distributer ali uvoznik pristojnemu organu predloži certifikat, ki ga izda priglašeni organ, imenovan za vrsto pripomočkov, ki so predmet dejavnosti iz točk (a) in (b) odstavka 2, s katerimi potrjuje, da je sistem vodenja kakovosti, vzpostavljen s strani distributerja ali uvoznika, skladen z zahtevami iz odstavka 3.
At least 28 days prior to making the relabelled or repackaged device available on the market, distributors or importers carrying out any of the activities mentioned in points (a) and (b) of paragraph 2 shall inform the manufacturer and the competent authority of the Member State in which they plan to make the device available of the intention to make the relabelled or repackaged device available and, upon request, shall provide the manufacturer and the competent authority with a sample or mock-up of the relabelled or repackaged device, including any translated label and instructions for use.
Člen 17
Within the same period of 28 days, the distributor or importer shall submit to the competent authority a certificate, issued by a notified body designated for the type of devices that are subject to activities mentioned in points (a) and (b) of paragraph 2, attesting that the quality management system of the distributer or importer complies with the requirements laid down in paragraph 3.
Pripomočki za enkratno uporabo in njihova ponovna obdelava
Article 17
Ponovna obdelava in nadaljnja uporaba pripomočkov za enkratno uporabo je mogoča le, če jo dopušča nacionalno pravo in je skladna s tem členom.