natgillin/translations-raw huggingface dataset:
7 .4.4 Če pripomoček kot sestavni del, vsebuje derivat človeške krvi zahteva priglašeni organ, potem ko preveri uporabnost snovi kot dela medicinskega pripomočka in ob upoštevanju predvidenega namena pripomočka, znanstveno mnenje od EMEA o kakovosti in varnosti snovi in o razmerju med klinično koristjo in tveganjem vključitve te snovi v pripomoček.
7.4.4 Where a device incorporates, as an integral part, a human blood derivative, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device, seek a scientific opinion from the EMEA on the quality and safety of the substance and on the clinical benefit/risk profile of the incorporation of the substance into the device.
Kadar se pomožna snov, vključena v medicinski pripomoček, zlasti v zvezi s postopkom izdelave, spremeni, se oceni po analogiji s postopki za vrednotenje sprememb zdravil iz uredb Komisije (ES) št. 1084/2003(**) in (ES) št. 1085/2003(***).
Where changes are made to an ancillary substance incorporated in a medical device, in particular related to its manufacturing process, they shall be assessed by analogy with the procedures for the evaluation of variations to medicinal products laid down in Commission Regulations (EC) No. 1084/2003 (**) and EC No.1085/2003 (***).
7.4.5 Kadar se pomožna snov, vključena v medicinski pripomoček, zlasti v zvezi s postopkom izdelave, spremeni, je priglašeni organ obveščen o spremembi in se posvetuje z ustreznim pristojnim organom za zdravila (tj. tisti, ki sodeluje pri začetnem posvetovanju), zato da se potrdi ohranjanje kakovosti in varnosti pomožne snovi ter zagotovi, da spremembe nimajo negativnega vpliva na razmerje med koristjo in tveganjem dodajanja snovi medicinskemu pripomočku.
7.4.5 Where changes are made to an ancillary substance incorporated in a medical device, in particular related to its manufacturing process, the notified body shall be informed of the changes and shall consult the relevant medicines competent authority (i.e. the one involved in the initial consultation), in order to confirm that the quality and safety of the ancillary substance are maintained, and to ensure that the changes have no negative impact on the established benefit/risk profile of the addition of the substance in the medical device.
Kadar ima ustrezni pristojni organ za zdravila (tj. tisti, ki sodeluje pri začetnem posvetovanju) podatke o pomožni snovi, ki bi lahko vplivala na vzpostavljeno razmerje med koristjo in tveganjem vključitve te snovi v medicinski pripomoček, priglašenemu organu predloži posodobljeno znanstveno mnenje.
When the relevant medicines competent authority (i.e. the one involved in the initial consultation) has information on the ancillary substance which could have an impact on the established benefit/risk profile of the incorporation of the substance into the medical device, it shall provide the notified body with an updated scientific opinion.
Priglašeni organ posodobljeno znanstveno mnenje upošteva pri ponovni preučitvi svoje ocene postopka ocenjevanja skladnosti.
The notified body shall take the updated scientific opinion into account in reconsidering its assessment of the conformity assessment procedure.
(***) UL L 159, 27.6.2003, str.
(***) OJ L 159, 27.6.2003, p.
PRILOGA II, TOČKA 1 (C)
ANNEX II, POINT 1 (C)
Priloga I, oddelek 7.4 a (Direktiva 93/42/EGS)
Annex I, section 7.4a (Directive 93/42/EEC)
Če pripomoček, kot sestavni del, vsebuje izdelek, ki lahko velja, če se uporablja ločeno, za izdelek iz človeških tkiv v smislu [člena 2(2) Uredbe o naprednih terapijah in spremembi Uredbe (ES) št. 726/2004] , in ki ima verjetno ob tem pripomočku na telo dopolnilni učinek, je treba kakovost, varnost in uporabnost izdelka preveriti po analogiji z metodami iz Uredbe (ES) št. […] [o naprednih terapijah in spremembi Uredbe (ES) št. 726/2004].
Where a device incorporates, as an integral part, a product which, if used separately, may be considered to be a human tissue engineered product within the meaning of [Article 2 (2) of the Regulation on Advanced Therapies and amending Regulation (EC) No 726/2004] and which is liable to act upon the body with action that is ancillary to that of the device, the quality, safety and usefulness of the product must be verified by analogy with the methods specified in Regulation EC No. [...] [on Advanced Therapies and amending Regulation (EC) No 726/2004].
Priglašeni organ zahteva, potem ko preveri uporabnost izdelka kot dela medicinskega pripomočka in ob upoštevanju predvidenega namena pripomočka, od [Odbora za napredne terapije] znanstveno mnenje o kakovosti in varnosti izdelka.
The notified body shall, having verified the usefulness of the product as part of the medical device and taking account of the intended purpose of the device, seek a scientific opinion from the [Committee of Advanced Therapies] on the quality and safety of the product.
Ob izdaji mnenja upošteva [Odbor za napredne terapije] postopek izdelave in podatke, povezane z vključitvijo izdelka v pripomoček.
When issuing its opinion, the [Committee of Advanced Therapies] shall take into account the manufacturing process and the data related to the incorporation of the product into the device.
Če pripomoček, kot sestavni del, vsebuje izdelek, ki lahko velja, če se uporablja ločeno, za izdelek iz človeških tkiv v smislu [člena 2(2) Uredbe o naprednih terapijah in spremembi Uredbe (ES) št. 726/2004] in katerega celični ali tkivni del vsebuje le tkiva ali celice, ki niso sposobna živeti, ter ki ima verjetno ob tem pripomočku na telo dopolnilni učinek, je treba kakovost, varnost in uporabnost izdelka preveriti po analogiji z metodami iz točke 5 dela IV Priloge I k Direktivi 2001/83/ES, kakor je bila nazadnje spremenjena.
Where a device incorporates, as an integral part, a product which, if used separately, may be considered to be a human tissue engineered product within the meaning of [Article 2 (2) of the Regulation on Advanced Therapies and amending Regulation (EC) No 726/2004], and whose cellular or tissue part contains solely non-viable tissues or cells and which is liable to act upon the body with action that is ancillary to that of the device, the quality, safety and usefulness of the product must be verified by analogy with the methods specified in Annex I, part IV, point 5 of Directive 2001/83/EC as last amended.
Priglašeni organ zahteva, potem ko preveri uporabnost izdelka kot dela medicinskega pripomočka in ob upoštevanju predvidenega namena pripomočka, od EMEA znanstveno mnenje o kakovosti in varnosti izdelka.
The notified body shall, having verified the usefulness of the product as part of the medical device and taking account of the intended purpose of the device, seek a scientific opinion from the EMEA on the quality and safety of the product.
Sedanji sistem, ki priglašenim organom omogoča, da zahtevajo mnenje od katerega koli ustreznega nacionalnega organa, je treba ohraniti, da se zagotovi pravočasno in stroškovno učinkovito upoštevanje varnosti in kakovosti zadevne snovi.
The current system, which allows Notified Bodies to seek the opinion from any of the relevant national authorities, should be maintained in order to ensure timely and cost effective consideration of the safety and quality of the substance in question.
Obveznost ocene uporabnosti vključitve medicinske snovi v medicinski pripomoček mora ostati obveznost organa za ocenjevanje, ki je odgovoren za celovito oceno pripomočka.
The duty to evaluate the usefulness of including the medicinal substance in the medical device should remain in the hands of the evaluation body responsible for the overall assessment of the device.
PRILOGA II, TOČKA 1 (C A) (novo) Priloga I, oddelek 7.5 (Direktiva 93/42/EGS)
ANNEX II, POINT 1 (C A) (new) Annex I, Section 7.5 (Directive 93/42/EEC)
(ca) Oddelek 7.5 se nadomesti z:
(ca) Section 7.5 is replaced by the following:
"Pripomoček mora biti zasnovan in proizveden na tak način, da bodo tveganja, ki jih povzročajo iz pripomočka uhajajoče snovi, čim manjša.
The devices must be designed and manufactured in such a way as to reduce to a minimum the risks posed by substances leaking from the device.
Pripomočki ne vsebujejo snovi, ki so v skladu z Prilogo I k Direktivi 67/584/EGS razvrščene med kancerogene, mutagene ali strupene za razmnoževanje iz skupine 1 in 2, razen če ni na voljo nobenih alternativnih naprav brez takšnih snovi."
Devices shall not contain substances classified as carcinogenic, mutagenic or toxic for reproduction, category 1 or 2, under Annex I to Directive 67/548/EEC, unless no alternative devices not containing such substances are available."
Uporaba kancerogenih in mutagenih snovi ter snovi, strupenih za razmnoževanje (snovi CMR), je v pravu EU že prepovedana v snoveh in pripravkih za javno uporabo ter v kozmetiki.
The use of CMR substances is already prohibited in EU law in substances and preparations for use of the general public and in cosmetics.
Poleg tega so za uporabo v vseh igračah prepovedani določeni ftalati, ki so strupeni za razmnoževanje.
Furthermore, certain phthalates that are toxic to reproduction have been banned from the use in all toys.
Seveda pa je izpostavljenost takšnim ftalatom v medicinskih pripomočkih lahko precej večja.
However, the exposure to such phthalates from medical devices can be far higher.
Bolniki so že po definiciji ranljivi in ne bi smeli biti po nepotrebnem izpostavljeni snovem CMR.
Patients are by definition vulnerable and should not be unnecessarily exposed to CMR substances.
Treba je pojasniti, da medicinski pripomočki, ki vsebujejo snovi CMR, ne izpolnjujejo temeljnih zahtev, če so na voljo pripomočki brez snovi CMR.
It needs to be clarified that medical devices containing CMR substances do not fulfil the essential requirements, when safer devices without CMR substances are available.
PRILOGA II, TOČKA 1 (D A) (novo) Priloga I, oddelek 9.4 (novo) (Direktiva 93/42/EGS)
ANNEX II, POINT 1 (D A) (new) Annex I, Section 9.4. (new) (Directive 93/42/EEC)
(da) Vstavi se oddelek 9.4.:
(da) The following Section 9.4. is inserted:
PRILOGA II, TOČKA 1 (E)
ANNEX II, POINT 1 (E)
Priloga I, oddelek 12.1 a (Direktiva 93/42/EGS)
Annex I, section 12.1a (Directive 93/42/EEC)
12.1a Za pripomočke, ki vsebujejo programsko opremo ali ki so sami po sebi medicinska programska oprema, mora biti programska oprema potrjena v skladu s tehničnim razvojem ob upoštevanju načel razvojnega življenjskega cikla, obvladovanja tveganja, potrjevanja in preverjanja.
12.1a For devices which incorporate software or which are medical software in themselves, the software must be validated according to the state of the art taking into account the principles of development lifecycle, risk management, validation and verification.
Za pripomočke, ki vsebujejo programsko opremo, je na področju programske opreme treba upoštevati načela razvojnega življenjskega cikla, obvladovanja tveganja, potrjevanja in preverjanja.
12.1a For devices which incorporate software, in terms of the software the principles of development lifecycle, risk management, validation and verification should be taken into account.
Izraz potrjevanje je treba nadomestiti, da se prepreči odvečno zbiranje podatkov.
The term 'validation' should be replaced in order to prevent the collection of unnecessary data.
PRILOGA II, TOČKA 1 (F) Priloga I, oddelek 13.1, odstavek 1 (Direktiva 93/42/EGS)
ANNEX II, POINT 1 (F) Annex I, Section 13.1., paragraph 1 (Directive 93/42/EEC)
(f) V oddelku 13.1 se prvi odstavek nadomesti z:
(f) In Section 13.1. the first paragraph is replaced by the following:
(f) Oddelek 13.1 se nadomesti z:
(f) Section 13.1. is replaced by the following:
Vsakemu pripomočku morajo biti priložene informacije, potrebne za varno in pravilno uporabo, ob upoštevanju usposobljenosti in znanja morebitnih uporabnikov, in za določitev proizvajalca.“
Each device must be accompanied by the information needed to use it safely and properly , taking account of the training and knowledge of the potential users, and to identify the manufacturer."
Vsak pripomoček mora biti opremljen z informacijami, potrebnimi za varno in pravilno namensko uporabo, ob upoštevanju usposobljenosti in znanja morebitnih uporabnikov, in za določitev proizvajalca.
Each device must be provided with the information needed to use it safely and as intended , taking account of the training and knowledge of the potential users, and to identify the manufacturer.
Te informacije zajemajo podatke na nalepki in podatke v navodilih za uporabo.
This information comprises the details on the label and the data in the instructions for use.
Kolikor je to izvedljivo in primerno, morajo biti informacije, potrebne za varno uporabo, navedene na pripomočku samem in/ali na embalaži vsake enote oziroma, kjer je to primerno, na prodajni embalaži.
As far as practicable and appropriate, the information needed to use the device safely must be set out on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging.
Če pakiranje posameznih enot ne pride v poštev, morajo biti informacije navedene na letaku, ki je priložen enemu ali več pripomočkom.
If individual packaging of each unit is not practicable, the information must be supplied with one or more devices.
Izjema so pripomočki iz razreda I ali IIa, ki ne potrebujejo navodil za uporabo, če jih je mogoče uporabljati varno tudi brez njih.“
By way of exception, no such instructions for use are needed for devices in Classes I or IIa if they can be used safely without any such instructions.
V takem primeru mora proizvajalec zdravstvenim ustanovam zagotoviti možnost, da pravočasno zahtevajo informacije v pisni obliki."
In such a case the manufacturer must afford healthcare facilities the opportunity to request the information in paper format in a timely manner."
Omogočiti je treba, da strokovnjaki informacije o varni in pravilni uporabi medicinskih pripomočkov posredujejo prek sodobnih sredstev komuniciranja (npr. elektronskega označevanja).
There should be the possibility of providing information for the safe and correct use of medical devices by professionals through modern means of communication (e.g. e-labelling.
PRILOGA II, TOČKA 1 (G) (II) Priloga I, oddelek 13.3, točka (b) (Direktiva 93/42/EGS)
ANNEX II, POINT 1 (G) (II) Annex I, Section 13.3., point (b) (Directive 93/42/EEC)
(b) podatke, ki so nujno potrebni, da lahko uporabnik prepozna pripomoček in vsebino embalaže , vključno z mednarodno priznano oznako mednarodne nomenklature generičnih medicinskih pripomočkov ;
(b) the details strictly necessary for the user to identify the device and the contents of the packaging including the respective code of an internationally recognized generic medical device nomenclature ;
(b) podatke, ki so nujno potrebni, da lahko uporabnik prepozna pripomoček in vsebino embalaže;
(b) the details strictly necessary for the user to identify the device and the contents of the packaging;
Predlog spremembe odbora IMCO je bil v poročilo vključen brez glasovanja na podlagi člena 47.
IMCO amendment which has been incorporated in the report without vote on the basis of Rule 47.
Mednarodno priznana nomenklaturna oznaka, ki jo uvaja osnutek predloga, bi morala biti del informacij, ki jih posreduje proizvajalec, vendar ni treba zahtevati, da je navedena na nalepki, kot je bilo predlagano.
The "internationally recognized nomenclature code" introduced by the draft proposal should be considered part of the information supplied by the manufacturer, but it shall not be required to appear on the label as suggested.
Zahteva za navedbo takšnih kod, ki se nenehno posodabljajo, na nalepki izdelka bi lahko povzročila pogoste spremembe embalaže, kar bi proizvajalcem nakopalo precejšnje stroške, ne bi pa prispevalo k varnosti izdelka.
The obligation of putting such a code, which is constantly updated, on the label of the product might lead to frequent changes on the labels, which represent a significant cost for industry and does not add to the safety of the product.
Z dodajanjem oznak proizvodom, embalaži in navodilom za uporabo bi samo povečali upravne stroške, ne da bi to prineslo kakršnekoli ugodnosti bolnikom.
Adding more codes to products, packaging and instructions for use will only add administrative costs without offering any benefits to patients.
Oznake iz nomenklature generičnih medicinskih pripomočkov (GMDN) se že uporabljajo za poročanje o stalnem nadzoru, kar pristojnim organom omogoča, da ocenijo morebitna tveganja.
GMDN codes are already being used for vigilance reporting, hence allowing authorities to assess potential risk issues.
PRILOGA II, TOČKA 1 (G) (II A) (novo) Priloga I, oddelek 13.3, točka (f) (Direktiva 93/42/EGS)
ANNEX II, POINT 1 (G) (II A) (new) Annex I, Section 13.3., point (f) (Directive 93/42/EEC)
(iia) točka (f) se nadomesti z:
(iia) point (f) is replaced by the following:
"(f) navedbo, da je odgovornost proizvajalca omejena samo na enkratno uporabo, kjer je to primerno.
"(f) where appropriate, an indication that the liability of the manufacturer is limited to single use only .
Ta navedba ne izključuje ponovne predelave pripomočka v skladu s potrjenim postopkom."
This indication does not exclude the reprocessing of the device according to a validated procedure."
Ni dovolj jasno, kaj točno pomeni "enkratna uporaba medicinskih pripomočkov".
There is currently lack of clarity over the exact significance of the term "single use of medical devices".
V skladu s sedaj veljavno direktivo morajo oznake na medicinskih pripomočkih, ki jih namestijo proizvajalci, če je to primerno, vsebovati navedbo o tem, ali je pripomoček namenjen samo enkratni uporabi (Priloga II, 13.3 (f)).
Under the existing directive, the labels applied to medical devices set by manufacturers are required, if appropriate, to include an indication of whether the device is intended for single use only (Annex II, 13.3 (f)).
Zaradi terminološke nejasnosti nekatere države članice "enkratno uporabo" enačijo s tem, da "predelava ni možna".
Given the terminological confusion some Member States equate "single use" with "unprocessability".
Vendar države članice, v katerih je nadzorovana ponovna predelava dovoljena, priznavajo, da je vprašanje možnosti ponovne predelave odvisno zgolj od objektivnih meril ob uporabi kakovostnih in varnostnih standardov.
However, Member States where controlled reprocessing is permitted recognize that the question of reprocessability only depends on objective criteria making use of high quality and security standards.
Oznako "za enkratno uporabo" je torej treba razumeti kot omejitev odgovornosti proizvajalca na prvo uporabo pripomočka in ne kot navedbo o primernosti pripomočka za ponovno predelavo.
"Single use" label should be therefore interpreted as limiting the liability of the manufacturer to the device's first use, not as an indication of its suitability for reprocessing.
PRILOGA II, TOČKA 1 (H) (-I) (novo) Priloga I, oddelek 13.6, točka (i) (Direktiva 93/42/EGS)
ANNEX II, POINT 1 (H) (-I) (new) Annex I, Section 13.6., point (i) (Directive 93/42/EEC)
(-i) točka (i) se nadomesti z:
(-i) point (i) is replaced by the following:
„(i) datum zadnjega popravka navodil za uporabo“.
“(i) date of latest revision of the instructions for use”.
Ta določba, ki jo najdemo v Direktivi 98/79/ES o in vitro diagnostičnih medicinskih pripomočkih, je izjemno pomembna, ker se navodila za uporabo pogosto spreminjajo in se uvajajo nove različice.
This provision appears in Directive 98/79/EEC on in vitro diagnostic medical devices and is highly relevant, given the frequency with which the instructions for use are modified, with new versions being introduced.
Določba bo uporabnikom omogočila, da ugotovijo, ali imajo spremenjeno različico.
This will enable users to establish whether or not they have the modified versions.
Še toliko pomembnejša je, če se navodila lahko posredujejo elektronsko.
It is all the more important if instructions may be supplied electronically.
V spremenjenih različicah so pogosto izboljšave, ki temeljijo na izkušnjah, pridobljenih z uporabo pripomočka in katerih namen je preprečiti neželene učinke ali neprimerno uporabo.
The modified versions often contain improvements based on the experience gained while using the device, with the aim of preventing adverse incidents or inappropriate use.
Zato je ta podatek pomemben za varnost pripomočka.
This information is therefore relevant to the safety of the device.
PRILOGA II, TOČKA 1 (I A) (novo) Priloga I, oddelek 15 (novo) (Direktiva 93/42/EGS)
ANNEX II, POINT 1 (I A) (new) Annex I, Section 15 (new) (Directive 93/42/EEC)
(ia) Vstavi se naslednji oddelek 15:
(ia) The following Section 15 is inserted:
Če se ocenjuje kombiniran izdelek, mora pristojna agencija ali nacionalni organ pripraviti mnenje v 210 delovnih dneh."
Where a combined product is being assessed, the opinion of the competent agency or national authority must be drawn up within 210 processing days."
Potrebno je določiti rok za pripravo mnenj, da proizvajalci v razumnem roku izvedo, ali se njihov pripomoček lahko da na trg.
A deadline should be set for drawing up opinions so that manufacturers know whether or not their devices are to be allowed onto the market within a reasonable period of time.
PRILOGA II, TOČKA 7 (A)
ANNEX II, POINT 7 (A)
Priloga VII, oddelek 2 (Direktiva 93/42/EGS)
Annex VII, section 2 (Directive 93/42/EEC)
Proizvajalec mora pripraviti tehnično dokumentacijo, opisano v oddelku 3.
The manufacturer must prepare the technical documentation described in Section 3.
Proizvajalec ali njegov pooblaščeni zastopnik s sedežem v Skupnosti morata hraniti to dokumentacijo, skupaj z izjavo o skladnosti, na voljo državnim organom v inšpekcijske preglede za obdobje , ki je enako vsaj pričakovanemu roku trajanja izdelka, ki ga določi proizvajalec, vendar ne manj kot pet let od datuma proizvodnje.
The manufacturer or his authorized representative established in the Community must make this documentation, including the declaration of conformity, available to the national authorities for inspection purposes for a period at least equivalent to the intended lifetime of the product as defined by the manufacturer but not less than five years from the date of manufacture.
Proizvajalec ali njegov pooblaščeni zastopnik s sedežem v Skupnosti ali uvoznik morajo hraniti to dokumentacijo, skupaj z izjavo o skladnosti, na voljo državnim organom v inšpekcijske preglede za obdobje vsaj pet let od datuma proizvodnje.
The manufacturer or his authorized representative established in the Community or the importer must make this documentation, including the declaration of conformity, available to the national authorities for inspection purposes for a period of at least five years from the date of manufacture.
Zato da se prepreči birokracija, je treba tudi uvozniku omogočiti, da hrani ustrezne dokumente.
In order to cut down on bureaucracy, it should also be possible for the importer to keep the necessary documents.
PRILOGA II, TOČKA 7 (B) (III)
ANNEX II, POINT 7 (B) (III)
Priloga VII, oddelek 3, alinea 7 a (novo) (Direktiva 93/42/EGS)
Annex VII, Section 3, indent 7 a (new) (Directive 93/42/EEC)
„– klinično vrednotenje v skladu s Prilogo X,“
— the clinical evaluation in accordance with Annex X,
„– po potrebi klinično vrednotenje v skladu s Prilogo X,“
— where appropriate, the clinical evaluation in accordance with Annex X,
Ta priloga se uporablja za izdelke razreda I, kot so na primer loparčki, bombažne gaze, sprehajalne palice in okvirji za očala.
This annex is applicable to Class I products, such as tongue depressors, cotton gauzes, walking sticks and spectacles frames.
Za tovrstne proizvode ni potrebno zbrati vseh informacij za klinično vrednotenje.
It is not necessary to gather all the information for a clinical evaluation for this kind of products.
PRILOGA II, TOČKA 8 (A A) (novo)
ANNEX II, POINT 8 (A A) (new)
Priloga VIII, oddelek 2.1 (Direktiva 93/42/EGS)
Annex VIII, section 2.1 (Directive 93/42/EEC)
(aa) V oddelku 2,1 se četrta alinea nadomesti z:
(aa) In section 2.1 the fourth indent is replaced by the following:
„– posebne značilnosti pripomočkov, ki izhajajo iz recepta.“
"– the specific characteristics of the product as indicated by the prescription."
PRILOGA II, TOČKA 8 (E)
ANNEX II, POINT 8 (E)