natgillin/translations-raw huggingface dataset:
Če pripomoček, kot sestavni del, vsebuje snov, ki lahko velja, če se uporablja ločeno, za zdravilo iz člena 1 Direktive 2001/83/ES, in ki ima verjetno ob tem pripomočku na telo dopolnilni učinek, je treba kakovost, varnost in uporabnost te snovi preveriti po analogiji z metodami iz Direktive 2001/83/ES.
Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Directive 2001/83/EC.
Če pripomoček, kot sestavni del, vsebuje snov, ki lahko velja, če se uporablja ločeno, za zdravilo iz člena 1 Direktive 2001/83/ES in ki ima verjetno ob tem pripomočku na telo dopolnilni učinek, je treba kakovost, varnost in uporabnost te snovi preveriti po analogiji z ustreznimi metodami iz Priloge I Direktive 2001/83/ES.
Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the relevant methods specified in Annex I to Directive 2001/83/EC.
Za snov, ki:
For a substance which:
‑ je že pridobila, kot zdravilo, dovoljenje za trženje v Skupnosti v skladu z Uredbo Sveta (EGS) št. 2309/93(*) ali Uredbo (ES) št. 726/2004; ali
— has already been granted, as a medicinal product, a Community marketing authorisation in accordance with Council Regulation (EEC) No 2309/93 (*) or Regulation (EC) No 726/2004; or
– spada na področje uporabe Priloge k Uredbi (ES) št. 726/2004;
— falls within the scope of the Annex to Regulation (EC) No 726/2004;
‑ je derivat človeške krvi;
— is a human blood derivative;
zahteva priglašeni organ, potem ko preveri uporabnost snovi kot dela medicinskega pripomočka in ob upoštevanju predvidenega namena pripomočka, od Evropske agencije za zdravila (EMEA) znanstveno mnenje o kakovosti in varnosti snovi.
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 European Medicines Agency (EMEA) on the quality and safety of the substance.
Ob izdaji mnenja upošteva EMEA postopek izdelave in podatke, povezane z vključitvijo snovi v pripomoček.
When issuing its opinion, the EMEA shall take into account the manufacturing process and the data related to the incorporation of the substance into the device.
Priglašeni organ, potem ko preveri uporabnost snovi kot dela medicinskega pripomočka in ob upoštevanju kakovosti, varnosti in predvidenega namena pripomočka, od enega od pristojnih organov, ki jih imenujejo države članice v skladu z Direktivo 2001/83/ES, ali od Evropske agencije za zdravila (EMEA) zahteva znanstveno mnenje o kakovosti in varnosti snovi.
The notified body shall, having verified the usefulness of the substance as part of the medical device and taking account of the safety, quality and intended purpose of the device, seek a scientific opinion from one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or from the European Medicines Agency (EMEA) on the quality and safety of the substance.
Ob izdaji mnenja upošteva pristojni organ ali EMEA postopek izdelave in podatke, povezane z uporabnostjo vključitve snovi v pripomoček, kot to določa priglašeni organ .
When issuing its opinion, the competent authority or the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body .
Za druge snovi zahteva priglašeni organ, potem ko preveri uporabnost snovi kot dela medicinskega pripomočka in ob upoštevanju predvidenega namena pripomočka, od enega od pristojnih organov, ki jih imenujejo države članice v skladu z Direktivo 2001/83/ES, znanstveno mnenje o kakovosti in varnosti snovi.
For other substances , 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 one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC, on the quality and safety of the substance.
Ob izdaji mnenja upošteva zadevni pristojni organ postopek izdelave in podatke, povezane z vključitvijo snovi v pripomoček.
When issuing its opinion, the concerned competent authority shall take into account the manufacturing process and the data related to the incorporation of the substance into the device.
Za snov, ki je derivat človeške krvi , zahteva priglašeni organ, potem ko preveri uporabnost snovi kot dela medicinskega pripomočka in ob upoštevanju predvidenega namena pripomočka, od EMEA znanstveno mnenje o kakovosti in varnosti snovi.
For a substance which is 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.
Mnenje se pripravi v 210 delovnih dneh.
The opinion shall be drawn up within 210 processing days.
Ob izdaji mnenja upošteva EMEA postopek izdelave in podatke, povezane z uporabnostjo vključitve snovi v pripomoček , kot to določa priglašeni organ .
When issuing its opinion, the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body .
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 (***).
Priglašeni organ je 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.
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 se pomožna snov, vključena v medicinski pripomoček, 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.
Where changes are made to an ancillary substance incorporated in a medical device, 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.
Sedanji sistem, ki priglašenim organom omogoča, da se posvetujejo s katerim koli ustreznim nacionalnim organom, je treba ohraniti, da se zagotovi pravočasno in stroškovno učinkovito preverjanje varnosti in kakovosti zadevne snovi.
The current system, which allows notified bodies to consult 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.
Uporabnosti snovi ni mogoče oceniti, ne da bi najprej preverili njeno kakovost in varnost.
The usefulness of a substance cannot be evaluated without first taking into account the quality and safety of that substance.
Pri končni oceni medicinskega pripomočka mora priglašeni organ upoštevati mnenje ustreznega organa.
The notified body must take account of the authority's opinion when making its final assessment of the medical device.
PRILOGA I, TOČKA 5 A (novo)
ANNEX I, POINT 5 A (new)
Priloga VI, oddelek 2.1, alinea 1 (Direktiva 90/385/EGS)
Annex 6, section 2.1, indent 1 (Directive 90/385/EEC)
(5a) Prva alinea oddelka 2.1 Priloge 6 se nadomesti z naslednjim besedilom:
(5a) In Annex 6 the first indent of section 2.1 is replaced by the following:
„– podatke, ki so nujni za opredelitev zadevnega pripomočka.“
"– the information necessary for the identification of the product in question."
PRILOGA I, TOČKA 5 B (novo)
ANNEX I, POINT 5 B (new)
Priloga VI, oddelek 2.1, alinea 4 (Direktiva 90/385/EGS)
Annex 6, section 2.1, indent 4 (Directive 90/385/EEC)
(5b) Četrta alinea oddelka 2.1 Priloge 6 se nadomesti z naslednjim besedilom:
(5b) In Annex 6 the fourth indent of section 2.1 is replaced by the following:
„– posebne značilnosti pripomočkov, ki izhajajo iz zadevnega pisnega recepta.“
"– the specific characteristics of the product as indicated by the written prescription concerned."
Člen 1(d) navaja, da lahko zgoraj omenjeni recept (o uporabniku prilagojenih pripomočkih) izda vsak, ki ima na podlagi svojih poklicnih kvalifikacij za to dovoljenje.
Article 1(d) states that the prescription mentioned above (for custom-made devices) may be issued by anyone with the requisite professional qualifications.
V nasprotju s to izjavo zajema četrta alinea Priloge 2.1 le zdravniške recepte.
However, the fourth indent of section 2.1 of Annex 6 refers only to a doctor's prescription.
To neskladje je treba odpraviti.
This contradiction should be removed.
PRILOGA I, TOČKA 5 C (novo)
ANNEX I, POINT 5 C (new)
Priloga VI, oddelek 3 a (novo) (Direktiva 90/385/EGS)
Annex 6, section 3a (new) (Directive 90/385/EEC)
(5c) Prilogi 6 se doda naslednji oddelek:
(5c) In Annex 6, the following section is added:
Podatke, ki se v okviru te priloge navajajo v izjavi, je treba hraniti najmanj pet let od datuma njihove proizvodnje.“
The information included in the declarations covered by this Annex shall be kept for a minimum of five years from the date of manufacture."
Ne poznamo primera, v katerem je bilo treba podatke hraniti več kot pet let.
There is no known case in which information has needed to be kept for longer than five years.
Na podlagi tega se zdijo dodatne obremenitve proizvajalcev glede uporabniku prilagojenih pripomočkov, ki izhajajo iz sedanjega besedila, nesorazmerne.
The present wording seems to place an excessive burden on manufacturers of custom-made devices.
PRILOGA II, TOČKA 1 (A) Priloga I, oddelek 1 (Direktiva 93/42/EGS)
ANNEX II, POINT 1 (A) Annex I, Section 1 (Directive 93/42/EEC)
Pripomočki morajo biti načrtovani in izdelani tako, da ob predvidenem namenu pod predvidenimi pogoji in, če je primerno, na podlagi tehničnega znanja, izkušenj, izobraževanja in usposabljanja predvidenega uporabnika, ne ogrožajo kliničnega stanja ali varnosti bolnikov ali varnosti in zdravja uporabnikov ali, če je primerno, drugih oseb, pod pogojem, da vsako morebitno tveganje, povezano z njihovo uporabo, predstavlja sprejemljivo tveganje v primerjavi s koristjo za bolnika in da je združljivo z visoko ravnijo zaščite zdravja in varnosti.
The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended and, where applicable, by virtue of the technical knowledge, experience, education or training of intended users , they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their intended use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety.
To vključuje največje mogoče zmanjševanje tveganja napak uporabnika zaradi ergonomskih značilnosti pripomočka in okolja predvidenega uporabnika.“
This shall include reducing, as far as possible, risks posed by user error due to the ergonomic features of the device and its intended user environment.
Pripomočki morajo biti načrtovani in izdelani tako, da ob predvidenem namenu pod predvidenimi pogoji , ob upoštevanju zlasti dejstva, ali je pripomoček predviden za poklicno uporabo ali ne, ne ogrožajo kliničnega stanja ali varnosti bolnikov ali varnosti in zdravja uporabnikov ali, če je primerno, drugih oseb ali okolja , pod pogojem, da vsako morebitno tveganje, povezano z njihovo uporabo, predstavlja sprejemljivo tveganje v primerjavi s koristjo za bolnika in da je združljivo z visoko ravnijo zaščite zdravja , varnosti in okolja .
The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, taking into consideration, in particular, whether the device is intended for professional use or not , they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons or the environment , provided that any risks which may be associated with their intended use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health , safety and the environment .
Proizvajalec oceni in zmanjša potencialna tveganja napak uporabnika , ki so lahko povezane z ergonomskimi značilnostmi pripomočka in okolja predvidenega uporabnika.
The manufacturer shall evaluate and reduce potential risks posed by user error which may be associated with ergonomic features of the device and its intended user environment.
Za uskladitev teh direktiv z direktivo EU o zdravilih za uporabo pri ljudeh, da bo sklicevanje na splošne cilje direktive REACH, ki so že vključeni v te direktive, bolj eksplicitno.
In order to align these Directives with the EU Directive concerning medicines used in human beings to making a more explicit reference to the overall objectives being pursued by REACH already being integrated in these Directives.
Sklicevanje na "izobraževanje in strokovno usposabljanje" ter "napake pri uporabi" bi lahko povzročilo nejasnost in različne razlage.
Reference to ’education and training’ as well as’ use errors’ might trigger confusion and different interpretations.
Ključnega pomena je vedeti, ali je izdelek namenjen profesionalni uporabi in ali je za obliko izdelka izvedena notranja analiza tveganja.
What is essential is to know whether it is intended for professional use or not and whether an internal risk analysis on the product design is conducted.
PRILOGA II, TOČKA 1 (A A) (novo) Priloga I, oddelek 6 a (novo) (Direktiva 93/42/EGS)
ANNEX II, POINT 1 (A A) (new) Annex I, Section 6 a (new) (Directive 93/42/EEC)
(aa) Vstavi se oddelek 6a:
(aa) The following Section 6a is inserted:
Proizvajalci in/ali pooblaščeni zastopniki morajo v zvezi s ponovno predelavo svoje izdelke v Evropski uniji enotno deklarirati.
As regards re-processing, manufacturers and/or authorized representatives must declare their products uniformly within the European Union.
Pri deklariranju izdelka kot pripomočka za enkratno uporabo mora proizvajalec in/ali njegov zastopnik dokazati, zakaj se zadevni izdelek lahko uporabi le enkrat, ter določi lastnosti in tehnične dejavnike, ki v primeru, da bi bil izdelek deklariran kot pripomoček za večkratno uporabo, predstavljajo tveganje.
When declaring a product as a single-use device, the manufacturer and/or his representative shall be required to prove why the respective product can only be used once and he shall set out the characteristics and technical factors that would pose a risk were the product to be declared as a multiple-use device.
Proizvajalec in/ali njegov zastopnik tudi navedeta, pod kakšnimi tehničnimi pogoji bi bil pripomoček lahko zasnovan in proizveden kot izdelek za večkratno uporabo.
The manufacturer and/or his representative shall also declare under which technical conditions the device could be designed and produced as a multiple-use product.
Pri deklariranju izdelka kot pripomočka za večkratno uporabo proizvajalec ali njegov zastopnik zagotovita podrobno dokumentacijo o možnostih varne ponovne predelave pripomočka."
When declaring a product as a multiple-use device the manufacturer or his representative shall provide a detailed documentation on how the device can be safely reprocessed."
Klasifikacija uporabe medicinskih pripomočkov, za katero so trenutno odgovorni proizvajalci, ni vedno najbolj razumljiva.
The classification of the usage of medical devices is at the moment under the responsibility of the manufacturers and not always comprehensible.
Včasih so izdelki zasnovani in dani v promet kot izdelki za enkratno uporabo zato, da bi povečali prodajo in dobičke, čeprav bi bila izdelava pripomočka za večkratno uporabo ali tehnični razvoj v tej smeri zlahka mogoča.
Sometimes, products are designed and put on the market as single-use-products in order to enhance selling and boost profits whilst the construction as multiple-use device or the technical development in this direction would be easily possible.
Ekonomski pritisk pa lahko bolnišnice ali zdravnike prisili v ponovno uporabo izdelkov za enkratno uporabo, pri čemer te nimajo sredstev in znanja za njihovo čiščenje in ustrezno ravnanje z njimi.
Economic pressure can force hospitals or physicians nevertheless to re-use single-use products without having the means and the knowledge to clean and treat them properly.
PRILOGA II, TOČKA 1 (B) Priloga I, oddelek 7.4 (Direktiva 93/42/EGS)
ANNEX II, POINT 1 (B) Annex I, Section 7.4 (Directive 93/42/EEC)
Če pripomoček, kot sestavni del, vsebuje snov, ki lahko velja, če se uporablja ločeno, za zdravilo iz člena 1 Direktive 2001/83/ES, in ki ima verjetno ob tem pripomočku na telo dopolnilni učinek, je treba kakovost, varnost in uporabnost te snovi preveriti po analogiji z metodami iz Direktive 2001/83/ES.
Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Directive 2001/83/EC.
7.4.1 Če pripomoček, kot sestavni del, vsebuje snov, ki lahko velja, če se uporablja ločeno, za zdravilo iz člena 1 Direktive 2001/83/ES, in ki ima verjetno ob tem pripomočku na telo dopolnilni učinek, je treba kakovost, varnost in uporabnost te snovi ob upoštevanju predvidenega namena pripomočka preveriti po analogiji z ustreznimi metodami iz Direktive 2001/83/ES.
7.4.1 Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC and which is liable to act upon the body with action ancillary to that of the device, the quality, safety, and usefulness of the substance must be verified, taking account of the intended purpose of the device, by analogy with the appropriate methods specified in Directive 2001/83/EC.
Preverjanje uporabnosti snovi ostaja v pristojnosti priglašenega organa, medtem ko je vloga Evropske agencije za zdravila (EMEA) ali pristojnih organov, ki jih določijo države članice, zagotoviti znanstveno mnenje o kakovosti in varnosti snovi.
Authority to verify the usefulness of the substance remains with the notified body, whereas the role of the EMEA or the competent authorities designated by the Member States is to provide a scientific opinion on the quality and safety of the substance.
– je že pridobila, kot zdravilo, dovoljenje za trženje v Skupnosti v skladu z Uredbo Sveta (EGS) št. 2309/93(*) ali Uredbo (ES) št. 726/2004;
- has already been granted, as a medicinal product, a Community marketing authorisation in accordance with Council Regulation (EEC) No 2309/93 (*) or Regulation(EC) No 726/2004;
– spada na področje uporabe Priloge k Uredbi (ES) št. 726/2004;
- falls within the scope of the Annex to Regulation (EC) No 726/2004;
– je derivat človeške krvi;
- is a human blood derivative;
7.4.2 Za snovi iz prvega odstavka zahteva priglašeni organ, potem ko preveri uporabnost snovi kot dela medicinskega pripomočka in ob upoštevanju predvidenega namena pripomočka, znanstveno mnenje o kakovosti in varnosti snovi in o razmerju med klinično koristjo in tveganjem vključitve te snovi v pripomoček.
7.4.2 For the substances referred to in section 7.4.1 , 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 on the quality and safety of the substance and on the clinical benefit/risk profile of the incorporation of the substance into the device .
To znanstveno mnenje se izda ob upoštevanju postopka izdelave in podatkov , povezanih z vključitvijo snovi v pripomoček.
This scientific opinion shall be issued, taking into account the manufacturing process and the data related to the incorporation of the substance into the device.
Za druge snovi zahteva priglašeni organ , potem ko preveri uporabnost snovi kot dela medicinskega pripomočka in ob upoštevanju predvidenega namena pripomočka, od enega od pristojnih organov, ki jih imenujejo države članice v skladu z Direktivo 2001/83/ES , znanstveno mnenje o kakovosti in varnosti snovi .
For other substances, 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 one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC, on the quality and safety of the substance.
Ob izdaji mnenja upošteva zadevni pristojni organ postopek izdelave in podatke, povezane z vključitvijo snovi v pripomoček .
When issuing its opinion, the concerned competent authority shall take into account the manufacturing process and the data related to the incorporation of the substance into the device.
7.4.3 Za pridobitev znanstvenega mnenja iz oddelka 7.4.2 priglašeni organ obrne na enega od pristojnih organov, ki jih imenujejo države članice v skladu z Direktivo 2001/83/ES.
7.4.3 In order to obtain the scientific opinion referred to in section 7.4.2 , the notified body shall turn to one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC.
Ta pristojni organ v skladu z določbami iz Uredbe (ES) št. 726/2004 priglašenemu organu poda znanstveno mnenje ali pa priglašeni organ napoti na Evropsko agencijo za zdravila (EMEA), pri kateri prek njenih odborov pridobi znanstveno mnenje.
This competent authority shall , in accordance with the provisions of Regulation (EC) No 726/2004, either provide the scientific opinion to the notified body or refer the notified body to the European Medicines Agency (EMEA), through its committees, for the scientific opinion.