natgillin/translations-raw huggingface dataset:
· delovanje in usklajevanje priglašenih organov;
· The working of and coordination between Notified bodies;
· medicinski pripomočki s pomožnim izdelkom iz človeških tkiv;
· Medical devices with an ancillary human tissue engineered product;
· večja preglednost za splošno javnost.
· Increased transparency to the general public.
Vaš pripravljavec mnenja pozdravlja predlog Komisije, ki ga industrija tega sektorja že dolgo pričakuje.
Your draftsman welcomes the Commission's proposal, which has long been awaited by industry in the sector.
Praktični predlogi v tej direktivi bodo z določitvijo jasnejših in enostavnejših pravil izboljšali usklajenost v tem zelo kompleksnem in raznovrstnem sektorju.
The practical proposals in this Directive will improve harmonisation in this highly complex and diversified sector, by providing clearer and simpler rules.
Namen predloga je s povečanjem pravne jasnosti, preglednosti in varnosti za vse tržne udeležence in z izpopolnitvijo celotnega ureditvenega okvira podpreti hiter tehnični napredek, hkrati pa zagotoviti visoko raven varovanja javnega zdravja.
By increasing the legal clarity, transparency and certainty for all market players and by improving the overall regulatory framework, the proposal will support fast technical progress, while guaranteeing a high level of public health protection.
Vaš pripravljavec mnenja poudarja, da imajo lahko spremembe daljnosežen učinek na zadevne industrije, čeprav se na prvi pogled zdijo majhne in zgolj tehnične.
Your draftsman emphasises the fact that, even if the changes at first glance might seem small and technical, they can have a profound effect for the industry concerned.
Ponovno razvrščanje nekaterih pripomočkov v višjo kategorijo tveganja bi utegnilo, na primer, znatno povečati stroške.
For example, reclassification of certain devices in a higher risk category could increase costs considerably.
Po drugi strani sta lahko za pripomočke na meji med različnima opredelitvama ali za kombinirane pripomočke pravna jasnost in doslednost zelo pomembni, saj pojasnjujeta, katera direktiva, posledično pa kateri postopek, se uporablja zanje.
On the other hand, for devices operating on the borderline of different definitions or for combined devices, legal clarity and consistency can be very important, because it clarifies which directive and hence which procedure applies for them.
Vaš pripravljavec mnenja bi želel opozoriti, da bi moral biti obseg uporabe te pregledane direktive popolnoma usklajen z novo predlagano Uredbo o zdravilih za napredno zdravljenje, tako da bi morala vse izdelke pokrivati bodisi ta direktiva, bodisi nova uredba, s čimer bi se izognili nepotrebnemu prekrivanju.
Your draftsman would like to draw attention to the fact that the scope of this revised directive should be exactly in line with the new proposed Regulation on Advanced Therapies Medicinal Products, in the sense that all products should be covered either by this directive or by the new regulation and that unnecessary overlap should be avoided.
Komisija bi morala čim prej pripraviti predlog za pojasnitev obsega uporabe teh zakonodajnih aktov.
If necessary, the Commission should as soon as possible put forwards a proposal to clarify the scope of these legislative acts.
Končno sta mednarodno sodelovanje in usklajenost standardov bistvena, glede na dejstvo, da industrija v tem sektorju deluje na svetovnem trgu.
Finally, given the fact that industry in this sector operates on the global market, the process of international cooperation and harmonization of standards is a vital one.
Zato vaš pripravljavec mnenja meni, da bi si bilo treba bolj prizadevati za spodbujanje mednarodnega sodelovanja, tako z dvostranskimi sporazumi (sporazumi o vzajemnem priznavanju) kot z bolj neformalnim sodelovanjem (npr. delovna skupina za svetovno usklajevanje).
Your draftsman therefore believes that more effort should be made to promote international cooperation, both in the form of bilateral agreements (Mutual Recognition Agreements), as via more informal cooperation (e.g. the Global Harmonization Task Force).
Odbor za industrijo, raziskave in energetiko poziva Odbor za okolje, javno zdravje in varnost hrane kot pristojni odbor, da v svoje poročilo vključi naslednje predloge sprememb:
The Committee on Industry, Research and Energy calls on the Committee on the Environment, Public Health and Food Safety, as the committee responsible, to incorporate the following amendments in its report:
(21a) Predelava medicinskih pripomočkov je v smislu zmanjšanja stroškov obetajoč sektor.
(21a) Reprocessing medical devices is a sector that promises costs savings.
Glede na trenutno odsotnost enakih pogojev delovanja v EU in potrebo, da se zagotovi varnost bolnika, mora Komisija pripraviti predlog predelave medicinskih pripomočkov, ki bo temeljil na oceni vpliva in tržni študiji.
Taking into account the current lack of a level playing field in the EU and the need to ensure patient safety, the Commission should come forward with a proposal on medical device reprocessing, based on an impact assessment and a study of the market.
Predelava medicinskih pripomočkov na ravni EU trenutno ni urejena.
Currently, the reprocessing of medical devices is not regulated on EU level.
V skladu s podatki EAMDR bi lahko v EU, če bi v polni meri izrabili zmožnosti predelave medicinskih pripomočkov, dosegli prihranke pri stroških, ki bi znašali okoli 3 milijarde evrov.
According to figures of EAMDR, cost savings of about 3 billion EUR a year could be achieved in the EU by making full use of the potential of medical device reprocessing.
Da bi zagotovili varnost bolnikov, se mora zakonodaja osredotočiti na kakovost predelave.
To ensure patient safety, the legislation should focus on the quality of reprocessing.
Vsak predlog mora temeljiti na natančni oceni vpliva, temelječi na obstoječih predpisih v državah članicah, in na tržni študiji.
Any proposal should be based on a proper impact assessment, focusing on existing regulation in Member States, and a study of the market.
ČLEN 2, TOČKA 1, TOČKA (A), TOČKA (I A) (novo)
ARTICLE 2, POINT 1, POINT (A), POINT (I A) (new)
Člen 1, odstavek 2, točka (a) (Direktiva 93/42/EGS)
Article 1, paragraph 2, point (a) (Directive 93/42/EEC)
(ia) v točki (a) se doda naslednji zaključni stavek:
(ia) in point (a) the following closing phrase is added:
V okviru te direktive morajo biti vse kontaktne leče obravnavane kot medicinski pripomočki;
Under this Directive, all contact lenses should be deemed to be medical devices;
Kozmetične leče v Evropi trenutno ne veljajo za medicinske pripomočke, čeprav imajo iste učinke in predstavljajo možno tveganje za zdravje oči, če niso pravilno izdelane ali če se jih uporablja brez posvetovanja in nadzora očesnega specialista.
Cosmetic lenses are not currently regulated as medical devices in Europe, even though they have the same effects and potential health risks on the eye if improperly manufactured or used without the consultation and supervision of an eye care specialist.
ČLEN 2, TOČKA 1, TOČKA (F), TOČKA (I)
ARTICLE 2, POINT 1, POINT (F), POINT (I)
Člen 1, odstavek 5, točka (c) (Direktiva 93/42/EGS)
Article 1, paragraph 5, point (c) (Directive 93/42/EEC)
„(c) zdravila, ki jih ureja Direktiva 2001/83/ES.
“(c) medicinal products covered by Directive 2001/83/EC.
Pri odločanju, ali izdelek ureja navedena direktiva ali ta direktiva, je treba upoštevati zlasti glavno namensko uporabo zadevnega izdelka.“
In deciding whether a product falls under that Directive or the present Directive, particular account shall be taken of the principal mode of action of the product;”
Pri odločanju, ali izdelek ureja navedena direktiva ob uporabi definicije iz točke (b), člena 1(2), direktive 2001/83/EC 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 definition laid down in point (b) of Article 1(2) of Directive 2001/83/EC or under the present Directive, particular account shall be taken of the principal mode of action of the product;”
Predlagano direktivo je treba spremeniti, da bi natančneje opredelili definicijo medicinskih pripomočkov.
The proposed directive has to be altered in order to render more stringent the definition of medical devices.
Na ta način bi bilo tudi teže zdravilo registrirati kot medicinski pripomoček.
This would make it more difficult to have medication registered as medical devices.
Osnutek predloga Komisije za revizijo direktive vsebuje predloge sprememb oddelka definicij iz člena 1.
The draft Commission proposal for revision of the Directive includes amendments to the definitions section in Article 1.
Vendar je definicija "medicinskega pripomočka" v členu 1.2(a) v bistvu ista kot tista iz obstoječe direktive.
However, the definition of “medical device” at Article 1.2(a) is substantially the same as that set out in the existing Directive.
ČLEN 2, TOČKA 1, TOČKA (F), TOČKA (I A) (novo)
ARTICLE 2, POINT 1, POINT (F), POINT (I A) (new)
Pri odločanju, ali izdelek ureja direktiva 76/768/EC ali sedanja direktiva, je treba upoštevati zlasti glavni predvideni namen in način delovanja izdelka.“
In deciding whether a product falls under Directive 76/768/EC or this Directive, particular account shall be taken of the principal intended purpose of the product and the relevant mechanism of action;"
ČLEN 2, ODSTAVEK 1, TOČKA (G)
ARTICLE 2, POINT 1, POINT (G)
Člen 1, odstavek 6 (Direktiva 93/42/EGS)
Article 1, paragraph 6 (Directive 93/42/EEC)
(g) Odstavek 6 se črta.
(g) Paragraph 6 is deleted.
Namen tega predloga spremembe je ponovna vzpostavitev osebne zaščitne opreme iz te direktive.
This amendments seeks to reinstate the exemption of personal protective equipment from this Directive.
Te izdelke v zadostni meri ureja Direktiva 89/686/EGS.
These products are sufficiently covered by the Directive 89/686/EEC.
Izogibati bi se bilo treba nepotrebni uporabi dveh direktiv z različnima postopkoma ocenjevanja skladnosti.
Unnecessary application of two directives with different conformity assessment procedures should be avoided.
(1a) K členu 2 se doda naslednji odstavek:
(1a) The following paragraph is added to Article 2:
"Države članice storijo vse potrebno, da zagotovijo, da medicinski pripomočki, prodajani preko interneta, kataloške prodaje in drugih alternativnih distribucijskih kanalov, ne predstavljajo tveganja za zdravje in varnost potrošnikov in da so usklajeni z vsemi določbami iz sedanje direktive."
"Member States shall take all necessary steps to ensure that medical devices sold via the Internet, by mail order and other distribution channels do not put the health and safety of consumers at risk, and that they comply with all the provisions laid down in this Directive."
Prodaja medicinskih pripomočkov preko interneta, kataloške prodaje in drugih alternativnih distribucijskih kanalov postaja v mnogih evropskih državah vse bolj običajna in predstavlja, glede na to, da se izvaja brez posvetovanj ali nasvetov ustreznih specialistov, morebitno tveganje za zdravje evropskih državljanov.
Sales of medical devices over the internet, by mail order and other alternative distribution channels are becoming more and more common in many European countries and have potential health risks for European citizen since they are not subject to any consultation or counsel by appropriate specialists.
Člen 9, odstavek 3 (Direktiva 93/42/EGS)
Article 9, paragraph 3 (Directive 93/42/EEC)
3 Če država članica meni, da je treba klasifikacijska pravila iz Priloge IX prilagoditi glede na tehnični napredek in vse informacije, dostopne v okviru informacijskega sistema iz člena 10, predloži Komisiji ustrezno utemeljeno prošnjo in jo zaprosi za ustrezne ukrepe.
3 Where a Member State considers that the classification rules set out in Annex IX require adaptation in the light of technical progress and any information which becomes available under the information system provided for in Article 10, it shall submit a duly substantiated request to the Commission and ask it to take the necessary measures.
Komisija sprejme te ukrepe v skladu s postopkom iz člena 7(2).
The Commission shall adopt these measures in accordance with the procedure referred to in Article 7 (2).
Komisija zagotovi, da so pomembne informacije o predvidenih ukrepih takoj dostopne zainteresiranim stranem.
The Commission shall ensure that relevant information about envisaged measures is made available to interested parties without delay.
Da bi industrija lahko dobro načrtovala stroškovno učinkovite naložbe v raziskave in razvoj ter proizvodnjo, je treba čim prej objaviti pomembne informacije o predvidenih spremembah klasifikacije.
In order for industry to be able to make well-planned and cost-effective investments in R&D and production, relevant information about envisaged changes to the classification should be made known as quickly as possible.
ČLEN 2, TOČKA 5, TOČKA (A)
ARTICLE 2, POINT 5, POINT (A)
(a) V odstavku 3 se besede „Priloga IV, V ali VI“ nadomestijo s „Priloga II, IV, V ali VI“.
(a) In paragraph 3, the words “Annex IV, V or VI” are replaced by “Annex II, IV, V or VI”.
Pristojni organi sporočijo take odločitve in njihove obrazložitve drugim državam članicam in zainteresiranim stranem .
Such decisions , and the justifications for the decisions, shall be communicated by the competent authority to the other Member States and to the interested parties .
ČLEN 4, ODSTAVEK 1, PODODSTAVEK 2
ARTICLE 4, PARAGRAPH 1, SUBPARAGRAPH 2
Te določbe začnejo uporabljati [ 12 mesecev po prenosu].
They shall apply those provisions from [ 12 months from the transposition].
Te določbe začnejo uporabljati [ 18 mesecev po prenosu].
They shall apply those provisions from [ 18 months from the transposition].
Prehodno obdobje mora biti dovolj dolgo, da imajo izdelovalci dovolj časa za potrebna testiranja in uporabe, da ne bi po nepotrebnem prekinjali proizvodnje v teku.
The transitional period should be sufficiently long to ensure that manufacturers will have enough time to perform the necessary tests and applications in order not to stop on-going production unnecessarily.
PRILOGA I, TOČKA 1, TOČKA (B)
ANNEX I, POINT 1, POINT (B)
Priloga I, oddelek 10, odstavek 4 a (novo) (Direktiva 90/385/EGS)
Annex I, Section 10, paragraph 4 a (new) (Directive 90/385/EEC)
Preverjanje uporabnosti snovi ostaja v pristojnosti priglašenega organa.
The notified body shall verify the usefulness of the substance.
Vloga Evropske agencije za zdravila (EMEA) ali pristojnih organov, ki jih določijo države članice, je samo, da priskrbijo znanstveno mnenje o kakovosti in varnosti snovi.
The sole role of the EMEA and the competent authorities designated by the Member States is to provide a scientific opinion on the quality and safety of the substance.
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 of the role of notified bodies and EMEA/competent authorities will prevent that approval of medicinal 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, TOČKA (B)
ANNEX II, POINT 1, POINT (B)
Priloga I, oddelek 7.4, odstavek 2, končni del (Direktiva 93/42/EGS)
Annex I, Section 7.4, paragraph 2, final part (Directive 93/42/EEC)
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.
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 , ali 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 national competent authority, designated by a Member State in accordance with Directive 2001/83/EC or from the EMEA on the quality and safety of the substance.
Ob izdaji mnenja upošteva pristojni organ ali EMEA postopek izdelave in zadevne podatke , kakor tudi uporabnost 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 related data as well as the usefulness of incorporation of the substance into the device as determined by the notified body.
Sedanji sistem, ki priglašenim organom omogoča, da pridobijo mnenje katerega koli nacionalnega pristojnega 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.
Dolžnost, da oceni uporabnost vključitve zdravilne snovi v medicinski pripomoček, ostaja v rokah 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, TOČKA (F)
ANNEX II, POINT 1, POINT (F)
Priloga I, oddelek 13.1, odstavek 1 (Direktiva 93/42/EGS)
Annex I, Section 13.1, paragraph 1 (Directive 93/42/EEC)
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 za varno uporabo v skladu z namenom , ob upoštevanju usposobljenosti in znanja morebitnih uporabnikov, in za določitev proizvajalca.“
For each device , 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 , must be provided .
Sprememba ustvarja pravno jasnost, tako da uvede splošno sprejet izraz "namenska uporaba".
Creates legal clarity by introducing the generally accepted term of "Intended use".
PRILOGA II, TOČKA 1, TOČKA (G), TOČKA (II)
ANNEX II, POINT 1, POINT (G), POINT (II)
Priloga I, oddelek 13.3, točka (b) (Direktiva 93/42/EGS)
Annex I, Section 13.3, point (b) (Directive 93/42/EEC)
(ii) točka (b) se nadomesti z:
(ii) point (b) is replaced by the following:
“(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;”
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 asses potential risk issues.
PRILOGA II, TOČKA 7, TOČKA (B), TOČKA (III)
ANNEX II, POINT 7, POINT (B), POINT (III)
Priloga VII, oddelek 3, alineja 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,
„– kjer je potrebno, klinično vrednotenje v skladu s Prilogo X,“
- where appropriate, the clinical evaluation in accordance with Annex X,
PRILOGA II, TOČKA 9, TOČKA (C), TOČKA (VII)
ANNEX II, POINT 9, POINT (C), POINT (VII)
Priloga IX, Oddelek 4.4 (Direktiva 93/42/EGS)
Annex IX, Section 4.4 (Directive 93/42/EEC)
(vii) V oddelku 4.4. se besedi „Neaktivni pripomočki“ nadomestita z besedo „Pripomočki“ .
(vii) in Section 4.4. the words ‘Non active devices’ are replaced by the word ‘Devices’
(vii) Oddelek 4,4 se nadomesti z naslednjim: "Pripomočki, namenjeni snemanju rentgenskih posnetkov za ustvarjanje diagnostičnih slih so v razredu IIa."
(vii) Section 4.4. is replaced by the following: "Devices intended for recording X-rays to generate diagnostic images are in Class IIa."
Izvirno besedilo bi lahko nehote obsegalo druge pripomočke (npr. snemanje diagnostičnih rentgenskih posnetkov na digitalnih medijih), za katere uvrstitev v razred IIa ne bi bila sorazmerna.
The original text could unintentionally cover other devices (e.g. recording of diagnostic X-ray images on digital media) for which the classification into Class IIa seems to be disproportionate.
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
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 of the Council as regards the review of the medical device directives
o predlogu Odločbe Sveta o posebnem programu, s katerim se bo izvajal sedmi okvirni program (2007 do 2011) Evropske skupnosti za atomsko energijo (Euratom) na področju jedrskih raziskav in usposabljanja
on the proposal for a Council decision concerning the specific Programme implementing the seventh Framework Programme (2007-2011) of the European Atomic Energy Community (Euratom) for nuclear research and training activities
o predlogu Odločbe Sveta o posebnem programu, s katerim se bo izvajal sedmi okvirni program (2007 do 2011) Evropske skupnosti za atomsko energijo (Euratom) na področju jedrskih raziskav in usposabljanja
on the proposal for a Council decision on concerning the specific Programme implementing the seventh Framework Programme (2007-2011) of the European Atomic Energy Community (Euratom) for nuclear research and training activities
– ob upoštevanju predloga Komisije Svetu ( KOM(2005)0445 )
– having regard to the Commission proposal to the Council ( COM(2005)0445 )
– ob upoštevanju člena 7 Pogodbe Euratom, v skladu s katerim se je Svet posvetoval s Parlamentom ( C6‑0386/2005 ),
– having regard to Article 7 of the Euratom Treaty, pursuant to which the Council consulted Parliament ( C6‑0386/2005 ),
– ob upoštevanju poročila Odbora za industrijo, raziskave in energetiko in mnenja Odbora za proračun ( A6‑0333/2006 ),
– having regard to the report of the Committee on Industry, Research and Energy and the opinion of the Committee on Budgets ( A6‑0333/2006 ),