natgillin/translations-raw huggingface dataset:
Single-use devices and their reprocessing
Vsaka fizična ali pravna oseba, ki ponovno obdeluje pripomoček za enkratno uporabo, da je ustrezen za nadaljnjo uporabo v Uniji, se šteje za proizvajalca ponovno obdelanega pripomočka in prevzame obveznosti proizvajalcev, določene v tej uredbi, med katere sodijo obveznosti, ki so povezane s sledljivostjo ponovno obdelanega pripomočka v skladu s poglavjem III te uredbe.
Reprocessing and further use of single-use devices may only take place where permitted by national law and only in accordance with this Article.
Obdelovalec pripomočka se za namen člena 3(1) Direktive 85/374/EGS šteje za proizvajalca.
Any natural or legal person who reprocesses a single-use device to make it suitable for further use within the Union shall be considered to be the manufacturer of the reprocessed device and shall assume the obligations incumbent on manufacturers laid down in this Regulation, which include obligations relating to the traceability of the reprocessed device in accordance with Chapter III of this Regulation.
Brez odstopanja od odstavka 2 lahko država članica sklene, da eno ali več pravil o obveznostih proizvajalcev iz te uredbe ne velja za pripomočke za enkratno uporabo, ki se ponovno obdelujejo in uporabljajo v zdravstveni ustanovi, če pri tem zagotovijo, da:
The reprocessor of the device shall be considered to be a producer for the purpose of Article 3(1) of Directive 85/374/EEC.
je ponovno obdelani pripomoček po varnosti in učinkovitosti enakovreden originalnemu ter da so izpolnjene zahteve iz točk (a), (b), (d), (e), (f), (g) in (h) člena 5(5);
By way of derogation from paragraph 2, as regards single-use devices that are reprocessed and used within a health institution, Member States may decide not to apply all of the rules relating to manufacturers' obligations laid down in this Regulation provided that they ensure that:
je ponovna obdelava izvedena v skladu s skupnimi specifikacijami, v katerih so podrobno navedene zahteve glede:
the safety and performance of the reprocessed device is equivalent to that of the original device and the requirements in points (a), (b), (d), (e), (f), (g) and (h) of Article 5(5) are complied with;
obvladovanja tveganja, vključno z analizo izdelave in materiala, s tem povezanih značilnosti pripomočka (obratni inženiring) in postopkov za odkrivanje sprememb pri zasnovi originalnega pripomočka, pa tudi njegove načrtovane uporabe po ponovni obdelavi,
the reprocessing is performed in accordance with CS detailing the requirements concerning:
potrditve postopkov v celotnem procesu, tudi korakov pri čiščenju,
risk management, including the analysis of the construction and material, related properties of the device (reverse engineering) and procedures to detect changes in the design of the original device as well as of its planned application after reprocessing,
sprostitve izdelka in testiranja učinkovitosti,
the validation of procedures for the entire process, including cleaning steps,
sistema vodenja kakovosti,
the product release and performance testing,
poročanja o zapletih pri pripomočkih, ki so bili ponovno obdelani, ter
the quality management system,
sledljivosti ponovno obdelanih pripomočkov.
the reporting of incidents involving devices that have been reprocessed, and
Države članice spodbujajo zdravstvene ustanove ter od njih lahko zahtevajo, da pacientom zagotavljajo informacije o uporabi ponovno obdelanih pripomočkov v zdravstvenih ustanovah in, kadar je to ustrezno, kakršne koli druge pomembne informacije o ponovno obdelanih pripomočkih, s katerim se pacienti zdravijo.
the traceability of reprocessed devices.
Države članice uradno obvestijo Komisijo in druge države članice o nacionalnih določbah, uvedenih v skladu s tem odstavkom, in razlogih za njihovo uvedbo.
Member States shall encourage, and may require, health institutions to provide information to patients on the use of reprocessed devices within the health institution and, where appropriate, any other relevant information on the reprocessed devices that patients are treated with.
Komisija poskrbi, da so te informacije javno dostopne.
Member States shall notify the Commission and the other Member States of the national provisions introduced pursuant to this paragraph and the grounds for introducing them.
Države članice lahko sklenejo, da se bodo določbe iz odstavka 3 uporabljale tudi za pripomočke za enkratno uporabo, ki jih na zahtevo zdravstvene ustanove ponovno obdela zunanji obdelovalec, pod pogojem, da se ponovno obdelani pripomoček vrne zadevni zdravstveni ustanovi v popolni obliki in zunanji obdelovalec ravna v skladu z zahtevami iz točk (a) in (b) odstavka 3.
The Commission shall keep the information publicly available.
Če te skupne specifikacije niso sprejete do 26. maja 2020, se ponovna obdelava izvede v skladu z vsemi ustreznimi harmoniziranimi standardi in nacionalnimi določbami, ki zajemajo vidike iz točke (b) odstavka 3.
The Commission shall adopt, in accordance with Article 9(1), the necessary CS referred to in point (b) of paragraph 3 by 26 May 2020.
Ponovno obdelujejo se lahko samo pripomočki za enkratno uporabo, ki so bili dani na trg v skladu s to uredbo ali pred 26. majem 2020 v skladu z Direktivo 93/42/EGS.
Those CS shall be consistent with the latest scientific evidence and shall address the application of the general requirements on safety and performance laid down in in this Regulation.
Ponovna obdelava pripomočka za enkratno uporabo je mogoča samo, če velja za varno v skladu z najnovejšimi znanstvenimi dokazi.
In the event that those CS are not adopted by 26 May 2020, reprocessing shall be performed in accordance with any relevant harmonised standards and national provisions that cover the aspects outlined in point (b) of paragraph 3.
Ime in naslov pravne ali fizične osebe iz odstavka 2 in druge pomembne informacije iz oddelka 23 Priloge I se navedejo na oznaki in, če je to ustrezno, v navodilih za uporabo ponovno obdelanega pripomočka.
Compliance with CS or, in the absence of CS, with any relevant harmonised standards and national provisions, shall be certified by a notified body.
Čeprav imena in naslova proizvajalca izvirnega pripomočka za enkratno uporabo ni več treba navesti na oznaki, sta vključena v navodila za uporabo ponovno obdelanega pripomočka.
Only single-use devices that have been placed on the market in accordance with this Regulation, or prior to 26 May 2020 in accordance with Directive 93/42/EEC, may be reprocessed.
Države članice, ki dovoljujejo ponovno obdelavo pripomočkov za enkratno uporabo, lahko ohranijo ali uvedejo nacionalne določbe, ki so strožje od tistih iz te uredbe in s katerimi na svojem ozemlju omejijo ali prepovedo:
Only reprocessing of single-use devices that is considered safe according to the latest scientific evidence may be carried out.
ponovno obdelavo pripomočkov za enkratno uporabo in prenos pripomočkov za enkratno uporabo v drugo državo članico ali tretjo državo z namenom njihove ponovne obdelave;
The name and address of the legal or natural person referred to in paragraph 2 and the other relevant information referred to in Section 23 of Annex I shall be indicated on the label and, where applicable, in the instructions for use of the reprocessed device.
omogočanje dostopnosti ali nadaljnjo uporabo ponovno obdelanih pripomočkov za enkratno uporabo.
The name and address of the manufacturer of the original single-use device shall no longer appear on the label, but shall be mentioned in the instructions for use of the reprocessed device.
Države članice uradno obvestijo Komisijo in druge države članice o teh nacionalnih določbah.
A Member State that permits reprocessing of single-use devices may maintain or introduce national provisions that are stricter than those laid down in this Regulation and which restrict or prohibit, within its territory, the following:
Komisija poskrbi, da so te informacije javno dostopne.
the reprocessing of single-use devices and the transfer of single-use devices to another Member State or to a third country with a view to their reprocessing;
Komisija do 27. maja 2024 pripravi poročilo o izvajanju tega člena ter ga predloži Evropskemu parlamentu in Svetu.
the making available or further use of reprocessed single-use devices.
Komisija na podlagi tega poročila po potrebi pripravi predloge za spremembo te uredbe.
Member States shall notify the Commission and the other Member States of those national provisions.
Člen 18
The Commission shall make such information publicly available.
Kartica o vsadku in informacije za paciente, ki imajo vsajen pripomoček
The Commission shall by 27 May 2024 draw up a report on the operation of this Article and submit it to the European Parliament and to the Council.
Proizvajalci pripomočkov za vsaditev pripomočku priložijo naslednje:
On the basis of that report, the Commission shall, if appropriate, make proposals for amendments to this Regulation.
informacije, ki omogočajo identifikacijo pripomočka, vključno z imenom pripomočka, serijsko številko, številko partije, UDI, modelom pripomočka ter imenom in naslovom proizvajalca ter njegovim spletnim mestom;
Article 18
vsa opozorila, previdnostne ukrepe ali ukrepe, ki jih mora upoštevati pacient ali zdravstveni delavec glede vzajemne interference ob razumno predvidljivih zunanjih vplivih, zdravniških pregledih ali okoljskih razmerah;
Implant card and information to be supplied to the patient with an implanted device
vse informacije o pričakovani življenjski dobi pripomočka in vseh potrebnih nadaljnjih ukrepih;
The manufacturer of an implantable device shall provide together with the device the following:
druge informacije, ki pacientu zagotavljajo varno uporabo pripomočka, vključno z informacijami iz točke (u) oddelka 23.4.
information allowing the identification of the device, including the device name, serial number, lot number, the UDI, the device model, as well as the name, address and the website of the manufacturer;
Priloge I. Za seznanjanje posameznih pacientov, ki so jim bili vsajeni pripomočki, se informacije iz prvega pododstavka zagotavljajo na kateri koli način, ki omogoča hiter dostop do teh informacij v jeziku ali jezikih, ki jih določi zadevna država članica.
any warnings, precautions or measures to be taken by the patient or a healthcare professional with regard to reciprocal interference with reasonably foreseeable external influences, medical examinations or environmental conditions;
Informacije so napisane tako, da jih nestrokovnjak brez težav razume, in se po potrebi posodabljajo.
any information about the expected lifetime of the device and any necessary follow-up;
Posodobljene informacije so pacientom na voljo prek spletnega mesta, navedenega v točki (a) prvega pododstavka.
any other information to ensure safe use of the device by the patient, including the information in point (u) of Section 23.4 of Annex I.
Poleg tega proizvajalec na kartici o vsadku, ki spremlja pripomoček, zagotovi informacije iz točke (a) prvega pododstavka.
The information referred to in the first subparagraph shall be provided, for the purpose of making it available to the particular patient who has been implanted with the device, by any means that allow rapid access to that information and shall be stated in the language(s) determined by the concerned Member State.
Države članice od zdravstvenih ustanov zahtevajo, da dajo pacientom, ki jim je bil vsajen pripomoček, na voljo informacije iz odstavka 1, in sicer na kateri koli način, ki omogoča hiter dostop do teh informacij, skupaj s kartico o vsadku, na kateri so podatki o njihovi identiteti.
The information shall be written in a way that is readily understood by a lay person and shall be updated where appropriate.
Iz obveznosti, določenih v tem členu, so izvzeti naslednji vsadki: medicinski materiali za šivanje, medicinske sponke, zobarska polnila, zobni aparati, zobne krone, vijaki, zagozde, ploščice, žice, igle, sponke in spojniki.
Updates of the information shall be made available to the patient via the website mentioned in point (a) of the first subparagraph.
Na Komisijo se prenese pooblastilo za sprejemanje delegiranih aktov v skladu s členom 115, s katerimi spremeni ta seznam tako, da nanj dodaja druge vrste vsadkov ali z njega vsadke črta.
In addition, the manufacturer shall provide the information referred to in point (a) of the first subparagraph on an implant card delivered with the device.
Člen 19
Member States shall require health institutions to make the information referred to in paragraph 1 available, by any means that allow rapid access to that information, to any patients who have been implanted with the device, together with the implant card, which shall bear their identity.
Izjava EU o skladnosti
The following implants shall be exempted from the obligations laid down in this Article: sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors.
V izjavi EU o skladnosti je navedeno, da so glede pripomočka, ki ga zajema, zahteve iz te uredbe izpolnjene.
The Commission is empowered to adopt delegated acts in accordance with Article 115 to amend this list by adding other types of implants to it or by removing implants therefrom.
Proizvajalec redno posodablja izjavo EU o skladnosti.
Article 19
Izjava EU o skladnosti vsebuje vsaj informacije iz Priloge IV in se prevede v uradni jezik Unije ali jezike, ki jih zahtevajo država članica ali države članice, v katerih je pripomoček dostopen.
EU declaration of conformity
Kadar so pripomočki v zvezi z vidiki, ki jih ta uredba ne zajema, predmet druge zakonodaje Unije, na podlagi katere je prav tako potrebna izjava EU o skladnosti proizvajalca za dokazovanje izpolnjevanja zahtev iz navedene zakonodaje, se pripravi enotna izjava EU o skladnosti, ki upošteva vse akte Unije, ki se uporabljajo za pripomoček.
The EU declaration of conformity shall state that the requirements specified in this Regulation have been fulfilled in relation to the device that is covered.
Ta izjava vsebuje vse informacije, ki so potrebne za identifikacijo zakonodaje Unije, na katero se izjava nanaša.
The manufacturer shall continuously update the EU declaration of conformity.
S pripravo izjave EU o skladnosti proizvajalec prevzame odgovornost za skladnost z zahtevami iz te uredbe in vso drugo zakonodajo Unije, ki se uporablja za pripomočke.
The EU declaration of conformity shall, as a minimum, contain the information set out in Annex IV and shall be translated into an official Union language or languages required by the Member State(s) in which the device is made available.
Na Komisijo se prenese pooblastilo za sprejemanje delegiranih aktov v skladu s členom 115, s katerimi zaradi tehničnega napredka spremeni osnovno vsebino izjave EU o skladnosti, določene v Prilogi IV.
Where, concerning aspects not covered by this Regulation, devices are subject to other Union legislation which also requires an EU declaration of conformity by the manufacturer that fulfilment of the requirements of that legislation has been demonstrated, a single EU declaration of conformity shall be drawn up in respect of all Union acts applicable to the device.
Člen 20
The declaration shall contain all the information required for identification of the Union legislation to which the declaration relates.
Oznaka skladnosti CE
By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for compliance with the requirements of this Regulation and all other Union legislation applicable to the device.
Pripomočki, razen pripomočkov, izdelanih za posameznega uporabnika, in pripomočkov, ki so predmet raziskave, za katere se šteje, da so skladni z zahtevami te uredbe, so opremljeni z oznako skladnosti CE, kot je predstavljena v Prilogi V.
The Commission is empowered to adopt delegated acts in accordance with Article 115 amending the minimum content of the EU declaration of conformity set out in Annex IV in the light of technical progress.
Za oznako CE veljajo splošna načela, določena v členu 30 Uredbe (ES) št. 765/2008.
Article 20
Oznaka CE se vidno, čitljivo in neizbrisno namesti na pripomoček ali njegovo sterilno pakiranje.
CE marking of conformity
Če takšna namestitev ni mogoča ali ni upravičena zaradi narave pripomočka, se oznaka CE namesti na embalažo.
Devices, other than custom-made or investigational devices, considered to be in conformity with the requirements of this Regulation shall bear the CE marking of conformity, as presented in Annex V.
Oznaka CE je navedena tudi v vseh navodilih za uporabo in na vsaki prodajni embalaži.
The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.
Oznaka CE je nameščena, preden je pripomoček dan na trg.
The CE marking shall be affixed visibly, legibly and indelibly to the device or its sterile packaging.
Lahko ji sledi piktogram ali kateri koli drug znak, ki označuje posebno tveganje ali uporabo.
Where such affixing is not possible or not warranted on account of the nature of the device, the CE marking shall be affixed to the packaging.
Oznaki CE po potrebi sledi identifikacijska številka priglašenega organa, odgovornega za postopke ugotavljanja skladnosti, določene v členu 52.
The CE marking shall also appear in any instructions for use and on any sales packaging.
Identifikacijska številka je navedena tudi v promocijskem gradivu, v katerem je navedeno, da pripomoček izpolnjuje zahteve za oznako CE.
The CE marking shall be affixed before the device is placed on the market.
Če pripomočke ureja druga zakonodaja Unije, ki prav tako določa namestitev oznake CE, ta kaže, da pripomočki izpolnjujejo tudi zahteve te druge zakonodaje.
It may be followed by a pictogram or any other mark indicating a special risk or use.
Člen 21
Where applicable, the CE marking shall be followed by the identification number of the notified body responsible for the conformity assessment procedures set out in Article 52.
Pripomočki za posebne namene
The identification number shall also be indicated in any promotional material which mentions that a device fulfils the requirements for CE marking.
Države članice ne ovirajo:
Where devices are subject to other Union legislation which also provides for the affixing of the CE marking, the CE marking shall indicate that the devices also fulfil the requirements of that other legislation.
dobavljanja pripomočkov, ki so predmet raziskave, raziskovalcu za namen klinične raziskave, če ti pripomočki izpolnjujejo pogoje iz členov 62 do 80 in člena 82, izvedbenih aktov, sprejetih v skladu s členom 81, ter Priloge XV;
Article 21
dostopnosti pripomočkov, izdelanih za posameznega uporabnika, na trgu, če je to skladno s členom 52(8) in Prilogo XIII.
Devices for special purposes
Pripomočki iz prvega pododstavka, razen pripomočkov iz člena 74, nimajo oznake CE.
Member States shall not create obstacles to:
Pripomočke, izdelane za posameznega uporabnika, spremlja izjava iz oddelka 1 Priloge XIII, ki je na voljo posameznemu pacientu ali uporabniku, identificiranemu z imenom, kratico ali numerično kodo.
investigational devices being supplied to an investigator for the purpose of a clinical investigation if they meet the conditions laid down in Articles 62 to 80 and Article 82, in the implementing acts adopted pursuant to Article 81 and in Annex XV;
Države članice lahko zahtevajo, da proizvajalec pripomočka, izdelanega za posameznega uporabnika, pristojnemu organu predloži seznam takih pripomočkov, ki so dostopni na njihovem ozemlju.
custom-made devices being made available on the market if Article 52(8) and Annex XIII have been complied with.
Države članice na obrtnih sejmih, razstavah, demonstracijah ali podobnih prireditvah ne ovirajo prikazovanja pripomočkov, ki niso skladni s to uredbo, če viden znak jasno navaja, da so taki pripomočki namenjeni samo za prikaz ali predstavitev in ne morejo biti dostopni, dokler niso skladni s to uredbo.
The devices referred to in the first subparagraph shall not bear the CE marking, with the exception of the devices referred to in Article 74.
Člen 22
Custom-made devices shall be accompanied by the statement referred to in Section 1 of Annex XIII, which shall be made available to the particular patient or user identified by name, an acronym or a numerical code.
Sistemi in paketi
Member States may require that the manufacturer of a custom-made device submit to the competent authority a list of such devices which have been made available in their territory.
Fizične ali pravne osebe pripravijo izjavo, če pripomočke z oznako CE zaradi njihovega dajanja na trg v obliki sistema ali paketa kombinirajo z naslednjimi drugimi pripomočki ali izdelki, in sicer na način, ki je skladen s predvidenim namenom pripomočkov ali drugih izdelkov, in v mejah uporabe, ki jo določijo njihovi proizvajalci:
At trade fairs, exhibitions, demonstrations or similar events, Member States shall not create obstacles to the showing of devices which do not comply with this Regulation, provided a visible sign clearly indicates that such devices are intended for presentation or demonstration purposes only and cannot be made available until they have been brought into compliance with this Regulation.
drugimi pripomočki z oznako CE;
Article 22
in vitro diagnostičnimi medicinskimi pripomočki z oznako CE, ki so skladni z Uredbo (EU) 2017/746;
Systems and procedure packs
drugimi izdelki, ki so v skladu z zakonodajo, ki se uporablja za navedene izdelke, vendar samo, kadar se uporabljajo v medicinskem postopku ali kadar je njihova prisotnost v sistemu ali paketu drugače upravičena.
Natural or legal persons shall draw up a statement if they combine devices bearing a CE marking with the following other devices or products, in a manner that is compatible with the intended purpose of the devices or other products and within the limits of use specified by their manufacturers, in order to place them on the market as a system or procedure pack:
Zadevna fizična ali pravna oseba v izjavi iz odstavka 1 navede, da:
other devices bearing the CE marking;
je preverila medsebojno kompatibilnost pripomočkov in, če je to ustrezno, drugih izdelkov v skladu s proizvajalčevimi navodili ter izpeljala svoje dejavnosti v skladu z navedenimi navodili;
in vitro diagnostic medical devices bearing the CE marking in conformity with Regulation (EU) 2017/746;
je zapakirala sistem ali paket in priložila zadevne informacije za uporabnike, vključno z informacijami, ki jih zagotovijo proizvajalci pripomočkov in drugih izdelkov, ki so bili sestavljeni;
other products which are in conformity with legislation that applies to those products only where they are used within a medical procedure or their presence in the system or procedure pack is otherwise justified.
je bila dejavnost kombiniranja pripomočkov in, če je to ustrezno, drugih izdelkov v en sistem ali paket izpeljana v skladu z ustreznimi metodami notranjega spremljanja, preverjanja in potrditve.
In the statement made pursuant to paragraph 1, the natural or legal person concerned shall declare that:
Vsaka fizična ali pravna oseba, ki z namenom dajanja na trg sterilizira sisteme ali pakete iz odstavka 1, po svoji izbiri uporablja enega od postopkov iz Priloge IX ali postopek iz dela A Priloge XI.
they verified the mutual compatibility of the devices and, if applicable other products, in accordance with the manufacturers' instructions and have carried out their activities in accordance with those instructions;
Uporaba navedenih postopkov in vključevanje priglašenega organa sta omejena na vidike postopka za zagotavljanje sterilnosti do odprtja ali poškodbe sterilne embalaže.
they packaged the system or procedure pack and supplied relevant information to users incorporating the information to be supplied by the manufacturers of the devices or other products which have been put together;
Fizična ali pravna oseba ob tem poda izjavo, da je bila sterilizacija opravljena v skladu s proizvajalčevimi navodili.