natgillin/translations-raw huggingface dataset:
2. „Države članice prav tako sprejmejo vse potrebne ukrepe za zagotovitev, da prodaja medicinskih pripomočkov prek interneta, po pošti in prek drugih distribucijskih kanalov ne ogroža zdravja in varnosti potrošnikov ter da je v skladu z vsemi določbami iz te direktive.“
Member States shall also take all necessary steps to ensure that sales of medical devices via the internet, by mail order and other alternative distribution channels do not put the health and safety of consumers at risk, and that such sales comply with all the provisions of this Directive.”
V skladu s členom 152-1 Pogodbe je pomembno, da se pri opredeljevanju in izvajanju vseh politik in dejavnosti Skupnosti zagotavlja visoka raven varovanja zdravja ljudi.
In line with Treaty article 152-1, it is important that a high level of human health protection shall be ensured in the definition and implementation of all Community policies and activities.
ČLEN 2, TOČKA (1)(a)(i)
ARTICLE 2, POINT (1), POINT (A), POINT (I)
Člen 1, odstavek 2, točka (a), uvodni del (Direktiva 93/42/EGS)
Article 1, paragraph 2, point (a), introductory part (Directive 93/42/EEC)
(a) ‚medicinski pripomoček‘ pomeni vsak instrument, aparat, napravo, programsko opremo , material ali drug predmet, ki se uporablja sam ali v kombinaciji, vključno s programsko opremo, potrebno za njegovo pravilno uporabo, ki ga je proizvajalec predvidel za uporabo na ljudeh z namenom:
(a) 'medical device’ means any instrument, apparatus, appliance, software , material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for medical purposes for human beings for the purpose of:
(a) ‚medicinski pripomoček‘ pomeni vsak instrument, aparat, napravo, material ali drug predmet, ki se uporablja sam ali v kombinaciji, vključno s programsko opremo, potrebno za njegovo pravilno uporabo, ki ga je proizvajalec predvidel za uporabo na ljudeh z namenom:
(a) 'medical device’ means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for medical purposes for human beings for the purpose of:
ČLEN 2, TOČKA (1)(a)(ia) (novo) Člen 1, odstavek 2, točka (a), pododstavek 2 (Direktiva 93/42/EGS)
ARTICLE 2, POINT 1, POINT (A), POINT (I A) (new) Article 1, paragraph 2, point (a), subparagraph 2 (Directive 93/42/EEC)
„in katerega
"and which does not
Varnost bolnikov je treba zagotoviti.
The patient safety has to be ensured.
Razlikovanje med medicinskimi pripomočki in zdravili bi moralo biti jasnejše.
The distinction between medical device and medicinal products must be made clearer.
ČLEN 2, TOČKA (1)(f)(i) Člen 1, odstavek 5, točka (c) (Direktiva 93/42/EGS)
ARTICLE 2, POINT (1), POINT (F), POINT (I) Article 1, paragraph 5, point (c) (Directive 93/42/EEC)
Pri odločanju, ali izdelek ureja navedena direktiva ob uporabi meril iz drugega pododstavka člena 1(2) navedene direktive ali ta direktiva, je treba upoštevati zlasti glavno namensko uporabo zadevnega izdelka.
In deciding whether a product falls under that Directive by virtue of the application of the criteria laid down in the second subparagraph of Article 1(2) or under the present Directive, particular account shall be taken of the principal mode of action of the product;
ČLEN 2, TOČKA (1)(f)(ia) (novo) Člen 1, odstavek 5, točka (d) (Direktiva 93/42/EGS)
ARTICLE 2, POINT 1, POINT (F), POINT (I A) (new) Article 1, paragraph 5, point (d) (Directive 93/42/EEC)
Pri odločanju, ali izdelek ureja navedena direktiva ali ta direktiva, je treba upoštevati zlasti glavni predvideni namen in način delovanja izdelka.“
In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal intended purpose of the product and the relevant mode of action;"
(Prvi stavek besedila je vzet iz izvirne direktive.)
(First sentence of the text has been taken from the original Directive)
Kadar je izdelek mogoče opredeliti kot „medicinski pripomoček“ in morebiti sodi tudi na področje uporabe drugih direktiv (npr. o zdravilih, kozmetiki, osebni zaščitni opremi, strojih), je treba direktivo, ki zanj velja, določiti na podlagi glavnega predvidenega namena in z njim povezanega delovanja izdelka, s čimer se zagotovi pravna varnost in jasnost za proizvajalca ter druge, ki jih to zadeva.
When a product falls under the definition of a "medical device" and potentially within the scope of other directives (e.g. medicinal products, cosmetics, PPE, machinery), the determination of the directive which should apply shall be based on evaluation of the principal intended purpose and related relevant mechanism of action of the product, to provide legal certainty/clarity to the manufacturer and other interested persons.
ČLEN 2, TOČKA (1)(g) Člen 1, odstavek 6 (Direktiva 93/42/EGS)
ARTICLE 2, POINT 1, POINT (G) Article 1, paragraph 6 (Directive 93/42/EEC)
Ta direktiva se ne uporablja za osebno zaščitno opremo, ki jo ureja Direktiva 89/686/EGS.
This Directive does not apply to personal protective equipment covered by Directive 89/686/EEC.
Pri odločanju, ali izdelek ureja navedena direktiva, je treba upoštevati zlasti glavni predvideni namen in način delovanja izdelka.“
In deciding whether a product falls under that Directive, particular account shall be taken of the principal intended purpose of the product and the relevant mode of action."
(Del besedila je vzet iz izvirne direktive.)
(Part of this wording has been taken from the original Directive)
Ne zadeva slovenske različice.
Self explanatory.
ČLEN 2, TOČKA (4)(b) Člen 11, odstavek 14 (Direktiva 93/42/EGS)
ARTICLE 2, POINT (4), POINT (B) Article 11, paragraph 14 (Directive 93/42/EEC)
ČLEN 2, TOČKA (13) Člen 20, odstavek 1, pododstavek 2 (Direktiva 93/42/EEC)
ARTICLE 2, POINT (13) Article 20, paragraph 1, subparagraph 2 (Directive 93/42/EEC)
PRILOGA I, TOČKA (1)(a)
ANNEX I, POINT (1), POINT (A)
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.
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, mora biti programska oprema potrjena v skladu s tehničnim razvojem, ob upoštevanju načel razvojnega življenjskega cikla, obvladovanja tveganja, potrjevanja in preverjanja.
For devices which incorporate software, 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.
PRILOGA II, TOČKA (1)(b) Priloga I, oddelek 7.4, pododstavki 1 do 4 (Direktiva 93/42/EGS)
ANNEX II, POINT (1), POINT (B) Annex I, section 7.4, subparagraphs 1 to 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 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 of Directive 2001/83/EC.
– 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;
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, 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 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 the 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.
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 the incorporation of the substance into the device as determined by the notified body.
(*) UL L214, 24.8.1993, str.
( * ) OJ L214, 24.8.1993, p.
Sedanji sistem, ki priglašenim organom omogoča, da pridobijo mnenje kateregakoli pristojnega nacionalnega organa, je treba ohraniti, da se zagotovi pravočasno in stroškovno učinkovito preverjanje 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.
PRILOGA II, TOČKA (1)(b) Priloga I, oddelek 7.4., podostavek 1 a (novo) (Direktiva 93/42/EGS)
ANNEX II, POINT 1, POINT (B) Annex I, section 7.4., subparagraph 1 a (new) (Directive 93/42/EEC)
Pojasnitev vloge priglašenih organov, agencije EMEA in pristojnih organov bo preprečila, da bi bila odobritev medicinskih pripomočkov, ki v praksi vključujejo v celoti dokumentirane medicinske snovi, obravnavana kot farmacevtska snov, kar bi dodalo nesorazmerne stroške in podaljšalo čas brez kakršnihkoli ugodnosti za bolnike.
Clarification on the role of notified bodies and EMEA/competent authorities will prevent that approval of medical devices with fully documented medicinal substances integrated in practice will be handled as a pharmaceutical, which would add disproportional costs and time without offering any benefits to patients.
PRILOGA II, ToČKA (1)(b) Priloga I, oddelek 7.4., pododstavek 5 (Direktiva 93/42/EGS)
ANNEX II, POINT (1), POINT (B) Annex I, section 7.4., subparagraph 5 (Directive 93/42/EEC)
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.
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.
PRILOGA II, TOČKA (1)(e)
ANNEX II, POINT (1), POINT (E)
Priloga I, oddelek 12.1a.
Annex I, section 12.1a.
(Direktiva 93/42/EGS)
(Directive 93/42/EEC)
PRILOGA II, TOČKA (1)(f) Priloga I, oddelek 13.1., odstavek 1 (Direktiva 93/42/EGS)
ANNEX II, POINT (1), POINT (F) Annex I, Section 13.1., paragraph 1 (Directive 93/42/EEC)
Če je 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.
V takem primeru mora proizvajalec zdravstvenim ustanovam pravočasno omogočiti, da zaprosijo za informacije v papirni obliki.
In such a case the manufacturer must afford healthcare facilities the opportunity to request the information in paper format in a timely manner.
Izjema so pripomočki iz razreda I ali IIa, če jih je mogoče uporabljati varno tudi brez takšnih navodil.
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."
(Besedilo je vzeto iz izvirne direktive.)
(The text has been taken from the original Directive)
PRILOGA II, TOČKA (1)(g)(ii) Priloga I, oddelek 13.3., točka (b) (Direktiva 93/42/EGS)
ANNEX II, POINT (1), POINT (G), POINT (II) Annex I, Section 13.3., point (b) (Directive 93/42/EEC)
PRILOGA II, TOČKA (8)(e)
ANNEX II, POINT (8), POINT (E)
Priloga VIII, oddelek 5, odstavek 1 (Direktiva 93/42/EGS)
Annex VIII, section 5, paragraph 1 (Directive 93/42/EEC)
Za uporabniku prilagojene pripomočke mora proizvajalec jamčiti, da bo uporabljal in ohranjal ažurne sistematične postopke za pregledovanje izkušenj, pridobljenih iz pripomočkov v fazi po proizvodnji, vključno z določbami iz Priloge X , in da bo uporabljal ustrezna sredstva za uveljavljanje vseh potrebnih korektivnih postopkov.
For custom-made devices, the manufacturer must undertake to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase , including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action.
To jamstvo mora vključevati tudi obveznost proizvajalca, da obvešča pristojne organe o naslednjih dogodkih in ustreznih korektivnih postopkih , takoj ko zanje izve:
This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents and the relevant corrective action immediately on learning of them:
PRILOGA II, TOČKA (9)(a)(i)
ANNEX II, POINT (9), POINT (A), POINT (I)
Priloga IX, poglavje I, oddelek 1.4 (Direktiva 93/42/EGS)
Annex IX, chapter I, section 1.4 (Directive 93/42/EEC)
(i) v oddelku 1.4 se doda stavek:
(i) in Section 1.4. the following sentence is added:
„Samostojna programska oprema se obravnava kot aktivni medicinski pripomoček.“
"Stand alone software is considered to be an active medical device."
PRILOGA II, TOČKA (9)(b) Priloga IX, poglavje II, oddelek 2.6.
ANNEX II, POINT (9), POINT (B) Annex IX, chapter II, section 2.6.
2.6 Pri izračunu trajanja iz oddelka 1.1 poglavja I pomeni neprekinjena uporaba nemoteno dejansko uporabo pripomočka za predvideni namen.
2.6 In calculating the duration referred to in Section 1.1 of chapter I, continuous use means an uninterrupted actual use of the device for the intended purpose.
Vseeno se to, če je uporaba pripomočka prekinjena, zato da se pripomoček takoj zamenja z istim ali istovetnim pripomočkom, obravnava kot podaljšanje neprekinjene uporabe pripomočka , razen če je mogoče dokazati, da takšno nadomestilo odpravlja vsako tveganje, ki izhaja iz neprekinjene uporabe pripomočka .
However where usage of a device is discontinued in order for the device to be replaced immediately by the same or an identical device this shall be considered an extension of the continuous use of the device , unless it can be demonstrated that such replacement eliminates any risk arising from a continued use of the device .
Predlog Direktive Evropskega parlamenta in Sveta o spremembi direktiv Sveta 90/385/EGS in 93/42/EGS ter Direktive Evropskega parlamenta in Sveta 98/8/ES glede ponovnega pregleda direktiv o medicinskih pripomočkih
Proposal for a directive of the European Parliament and of the Council amending Council Directives 90/385/EEC and 93/42/EEC and Directive 98/8/EC of the European Parliament and the Council as regards the review of the medical device directives
o predlogu direktive Evropskega parlamenta in Sveta o spremembi direktiv Sveta 90/385/EGS in 93/42/EGS ter Direktive Evropskega parlamenta in Sveta 98/8/ES glede ponovnega pregleda direktiv o medicinskih pripomočkih
on the proposal for a directive of the European Parliament and of the Council amending Council Directives 90/385/EEC and 93/42/EEC and Directive 98/8/EC of the European Parliament and the Council as regards the review of the medical device directives
Namen tega predloga je okrepiti konkurenčnost in varnost v sektorju medicinskih pripomočkov.
This proposal aims at strengthening the competitiveness and safety of the medical devices sector.
Medicinski pripomočki so vedno pomembnejši segment zdravstvenega sektorja, ki odločilno vplivajo tako na javno zdravje kot na izdatke za zdravstveno varstvo.
Medical devices form an increasingly important health-sector segment, with a major impact on both public health and healthcare expenditure.
Pojem "medicinski pripomoček" obsega številne izdelke.
The term "medical device" covers a wide range of products.
Na trgu lahko razlikujemo med približno 400.000 različnimi medicinskimi pripomočki, od preprostih (na primer injekcijske igle ali očala), prek opreme za raziskovanje in diagnosticiranje bolezni in zdravstvenih stanj do najbolj izpopolnjenih in kompleksnih instrumentov (na primer medicinski pripomočki za vsaditev, ki rešujejo življenje, diagnostično slikanje in oprema za minimalno invazivno kirurgijo).
Approximately 400.000 different medical devices can be distinguished on the market, ranging from simple devices (such as syringes and glasses), through equipment to screen and diagnose disease and health conditions, to the most sophisticated and complex instruments (like life-saving implantable devices, diagnostic imaging and minimal invasive surgery equipment).
Splošna javnost upravičeno pričakuje, da vsi ti izdelki dosegajo najvišje varnostne standarde.
The general public rightly expects all those products to meet the highest safety standards.
Obenem je sektor izredno pomemben za evropsko industrijo - sestavlja ga 7000 podjetij, v njih pa je zaposlenih več kot 350.000 ljudi in redno dosega eno največjih stopenj rasti proizvodnje - zanj pa je potreben skladen in jasen zakonodajni okvir, ki bo spodbujal konkurenčnost in inovacije.
At the same time, the sector is of significant importance to European industry - consisting of 7.000 companies, employing more than 350.000 people and regularly recording one of the highest production growth rates - and requires a coherent and clear legislative framework that fosters competitiveness and innovation.
Sedanji zakonodajni okvir, ki ureja tako zelo raznovrstne izdelke, obsega tri direktive.
The current legislative framework, regulating such a diverse variety of products, consists of three Directives.
Te skupaj opredeljujejo bistvene zahteve, ki jih morajo izpolnjevati medicinski pripomočki, ki so dani v promet, glede na njihovo razvrstitev (na primer presoja tveganja, obvladovanje tveganja in analiza tveganja in koristi).
Together, they define the essential requirements that medical devices have to meet when they are put on the market, depending on their classification (such as risk assessment, risk management and risk/benefit analysis).
Razen tega direktive določajo sistem postopkov za ocenjevanje skladnosti na osnovi tveganja, ki jih običajno izvajajo neodvisni organi (tako imenovani "priglašeni organi").
Furthermore, the Directives provide for a system of risk-based conformity assessment procedures, usually performed by independent bodies (the so-called "Notified bodies").
Nazadnje pa direktive nalagajo nacionalnim organom obveznost, da zagotovijo ustrezno delovanje trga, na primer s tržnim nadzorom, usmerjanjem, pripombami k standardom ali ponovnim razvrščanjem pripomočkov.
And finally, the Directives lay obligations on national authorities to ensure the proper functioning of the market, for example by instance by market surveillance, guidance, objections to standards or reclassification of devices.
Leta 2002 je Komisija pregledala delovanje ureditvenega okvira.
In 2002, the Commission reviewed the functioning of the regulatory framework.
Ob koncu pregleda je bilo sklenjeno, da direktive v splošnem zagotavljajo primeren pravni okvir.
The conclusion of the review was that on the whole the Directives provided an appropriate legal framework.
Vendar pa je v posameznih točkah še možno izboljšanje.
However, regarding specific points, room for improvement was possible.
Namen sedaj predlagane direktive je izboljšati te točke.
The current proposed Directive intends to fill in this room for improvement.
Najpomembnejši predlogi zadevajo pojasnitve na naslednjih področjih:
The most significant proposals concern clarifications in the following areas:
· ocenjevanje skladnosti, vključno z jasnimi pravili o projektni dokumentaciji in pregledu projektiranja;
· Conformity assessment, including clear rules on design documentation and design review;
· zahteve kliničnega vrednotenja;
· Clinical evaluation requirements;
· poprodajni nadzor in skladnost proizvajalcev uporabniku prilagojenih pripomočkov;
· Post market surveillance and compliance of custom-made device manufacturers;