natgillin/translations-raw huggingface dataset:
(a) uveljavljanje klasifikacijskih pravil iz Priloge IX zahteva sprejetje sklepa o klasifikaciji danega pripomočka ali kategorije pripomočkov;
(a) application of the classification rules set out in Annex IX requires a decision with regard to the classification of a given device or category of devices;
(b) mora biti dan pripomoček ali družina naprav razvrščen v drug razred, z odstopanjem od določb Priloge IX;
(b) a given device or family of devices should be classified, by way of derogation from the provisions of Annex IX, in another class;
(c) je treba dognati skladnost pripomočka ali družine pripomočkov, z odstopanjem od določb iz člena 11, z uporabo zgolj enega od danih postopkov, izbranega izmed postopkov v členu 11;
(c) the conformity of a device or family of devices should be established, by way of derogation from the provisions of Article 11, by applying solely one of the given procedures chosen from among those referred to in Article 11;
(d) zahteva odločitev , ali je izdelek opredeljen v členu 1(2)(a) do (e) ,
(d) a decision is required as to whether a particular product falls within one of the definitions in Article 1 paragraph 2, points (a) to (e) ,
poda Komisiji utemeljeno zahtevo in od nje zahteva, da sprejme potrebne ukrepe.
it shall submit a duly substantiated request to the Commission and ask it to take the necessary measures.
Te ukrepe se sprejme v skladu s postopkom iz člena 7(2a)."
These measures shall be adopted in accordance with the procedure referred to in Article 7(2a)."
Odločitev mora biti povezana s posameznim izdelkom, ker so kategorije izdelkov pogosto obsežne in posamezni izdelki v kategorijah izdelkov nimajo vedno enakih značilnosti in niso predvideni za enako uporabo.
Decisions must be taken on the basis of specific individual products, as product categories are often wide-ranging and products within the same category do not always have the same characteristics or purpose.
Predlog spremembe je potreben, da bi besedilo uskladili z določbami iz novega "komitološkega" sklepa in zlasti da bi vključili postopek "regulativnega odbora z nadzorom", ker so nekateri sklepi glede razvrstitve ukrepi splošnega obsega, namenjeni spreminjanju nebistvenih elementov osnutka zakonodaje.
The amendment is needed to align the text to the provisions of the new "commitology" Decision, and in particular to include the "regulatory committee with scrutiny", since some the decisions with regard to classification are measures of general scope designed to amend non-essential elements of the draft legislation.
ČLEN 2, ODSTAVEK 6 A (novo)
ARTICLE 2, POINT 6 A (new)
Člen 13, odstavek 1 a (novo) (Direktiva 93/42/EGS)
Article 13, paragraph 1 a (new) (Directive 93/42/EEC)
(6a) V člen 13 se vstavi naslednji odstavek 1a:
(6a) In Article 13, the following paragraph 1a is inserted:
Če prejme Komisija utemeljeno zahtevo države članice iz odstavka 1 (d) v zvezi z določenim izdelkom ali kategorijo izdelkov, izvede raziskavo trga, da ugotovi, ali podobni izdelki že obstajajo na skupnem trgu.
Should the Commission receive a substantiated request from a Member State pursuant to paragraph 1(d) regarding a particular device or device category, it shall carry out a market survey to ascertain whether similar devices exist within the internal market.
Na tej podlagi je treba sprejeti odločitev o razvrstitvi tega izdelka v skladu s postopkom iz odstavka 1.
Decisions on the classification of these devices should be taken on this basis, in line with the procedure referred to in paragraph 1.
Predvidena uporaba proizvajalca je po členu 1(2)(a) Direktive 93/42/EGS pomemben del opredelitve medicinskega pripomočka.
According to Article 1(2)(a) of Directive 93/42/EEC, the purpose intended by the manufacturer is an integral factor in the definition of a product as a medical device.
Zato je pomembno, da je pred odločitvijo proizvajalec vključen v ustrezno odločanje.
It is important, therefore, for the manufacturer to be involved in all decisions in the run-up to the final decision.
Če pripomoček sodi v Direktivo 93/42/EGS, nazadnje odloči Sodišče Evropskih skupnosti.
The European Court of Justice will ultimately decide whether or not a product falls within the scope of Directive 93/42/EEC.
Zato morajo imeti proizvajalci možnost zagotoviti, da lahko takšen primer predložijo Sodišču Evropskih skupnosti.
For this reason, manufacturers should have the opportunity to ensure that they are able to bring a case of this kind before the Court of Justice.
V nasprotnem primeru bi morali Sodišče Evropskih skupnosti v okviru člena 234 Pogodbe EU vključiti v dolgoletne postopke.
Otherwise they would have to refer the matter to the Court in a procedure under Article 234 of the EU Treaty lasting many years.
ČLEN 2, TOČKA 7 Člen 14, odstavek 2, pododstavek 1 (Direktiva 93/42/EGS)
ARTICLE 2, POINT 7 Article 14, paragraph 2, subparagraph 1 (Directive 93/42/EEC)
Če proizvajalec, ki daje pripomočke na trg pod lastnim imenom, v državi članici nima registrirane poslovne enote, imenuje enega pooblaščenega zastopnika.
Where a manufacturer who places devices on the market under his own name does not have a registered place of business in a Member State, he shall designate a single authorized representative.
Če proizvajalec, ki daje pripomoček na trg pod lastnim imenom, v državi članici nima registrirane poslovne enote, za ta pripomoček imenuje enega pooblaščenega zastopnika v Evropski uniji .
Where a manufacturer who places a device on the market under his own name does not have a registered place of business in a Member State, he shall designate for this device a single authorized representative in the European Union.
Potrebno je pojasnilo, da mora proizvajalec za pripomoček imenovati enega pooblaščenega zastopnika, ni pa mu treba imenovati istega pooblaščenega zastopnika za vse svoje pripomočke.
It must be made clear that a manufacturer must designate a single authorized representative for a device but need not necessarily designate the same authorized representative for his entire range of devices.
ČLEN 2, TOČKA 8 (A A) (novo)
ARTICLE 2, POINT 8 (A A) (new)
Člen 14 a, odstavek 1 a (novo) (Direktiva 93/42/EGS)
Article 14a, paragraph 1a (new) (Directive 93/42/EEC)
(aa) Vstavi se odstavek 1a: “ 1a .
(aa) The following paragraph 1a is inserted: “ 1a.
Za uporabniku prilagojene pripomočke baza podatkov vsebuje samo podatke, določene v odstavku 1(a)."
For custom-made devices the databank shall contain only the data specified in paragraph 1(a). ”
ČLEN 2, TOČKA 8 (B A) (novo)
ARTICLE 2, POINT 8 (B A) (new)
Člen 14 a, odstavek 4 (novo) (Direktiva 93/42/EGS)
Article 14a, paragraph 4 (new) (Directive 93/42/EEC)
(ba) Doda se naslednji odstavek:
(ba) The following paragraph is added:
Določbe tega člena prenehajo veljati ...*.
The provisions of this Article shall expire on ...*.
Najkasneje 12 mesecev pred prenehanjem veljavnosti teh določb Komisija oceni njihovo izvajanje ter dodano vrednost iz baze podatkov.
No later than 12 months before the expiry of these provisions, the Commission shall evaluate their application and the added value provided by the databank.
Komisija na podlagi te ocene po potrebi v skladu s členom 251 Pogodbe predloži zakonodajni predlog o ponovni vzpostavitvi baze podatkov."
On the basis of this evaluation the Commission shall, if necessary, present a legislative proposal in accordance with Article 251 of the Treaty on the renewed establishment of the databank."
* Pet let po začetku veljavnosti te direktive.
* Five years after the entry into force of this Directive.
Baza podatkov, ki je bila oblikovana pred 13 leti, še vedno ne deluje.
Thirteen years after it was thought up, the database is not yet up and running.
Zato je veliko držav članic v tem času vzpostavilo svoje lastne sisteme baz podatkov.
Consequently, several Member States have since set up their own database systems.
Evropski sistem stalnega nadzora deluje izjemno dobro.
The European vigilance system works outstandingly well.
ČLEN 2, TOČKA 9 Člen 14 b, odstavek 4 (Direktiva 93/42/EGS)
ARTICLE 2, POINT 9 Article 14b, paragraph 4 (Directive 93/42/EEC)
Če so nacionalni ukrepi upravičeni, sprejme Komisija potrebne ukrepe na ravni Skupnosti v skladu s postopkom iz člena 7(2) .
Where the national measures are justified, the Commission shall adopt the necessary Community measures in accordance with the procedure referred to in Article 7(2).
Če nacionalni ukrepi niso upravičeni, obvesti Komisija vse države članice in zadevne vpletene strani.
If the national measures are unjustified, the Commission shall inform all Member States and the consulted interested parties.
Če so nacionalni ukrepi upravičeni, sprejme Komisija potrebne ukrepe na ravni Skupnosti v skladu s postopkom iz člena 7(2a) .
Where the national measures are justified, the Commission shall adopt the necessary Community measures in accordance with the procedure referred to in Article 7(2a).
Predlog spremembe je potreben, da bi besedilo uskladili z določbami iz novega "komitološkega" sklepa in zlasti da bi vključili postopek "regulativnega odbora z nadzorom", saj gre pri zadevnih ukrepih za ukrepe splošnega obsega, namenjene spreminjanju nebistvenih elementov osnutka zakonodaje.
The amendment is needed to align the text to the provisions of the new "commitology" Decision, and in particular to include the "regulatory committee with scrutiny", since the measures concerned are measures of general scope designed to amend non-essential elements of the draft legislation.
ČLEN 2, TOČKA 10
ARTICLE 2, POINT 10
Člen 15, odstavek 2, pododstavek 1 (Direktiva 93/42/EGS)
Article 15, paragraph 2, subparagraph 1 (Directive 93/42/EEC)
Pri pripomočkih, ki spadajo v razred III, ter pripomočkih za vsaditev in dolgoročnih invazivnih pripomočkih, ki spadajo v razred IIa ali IIb, lahko proizvajalec začne ustrezno klinično preiskavo ob koncu obdobja 60 dni po priglasitvi, razen če ga pristojni organ v tem času obvesti o nasprotni odločitvi, utemeljeni s preudarki javnega zdravja ali javnega reda.
In the case of devices falling within Class III and implantable and long-term invasive devices falling within Class IIa or IIb, the manufacturer may commence the relevant clinical investigation at the end of a period of 60 days after notification, unless the competent authorities have notified him within that period of a decision to the contrary based on considerations of public health or public policy.
Pristojni organi sporočijo take odločitve drugim državam članicam.
Such decisions shall be communicated by the competent authority to the other Member States.
Pristojni organi sporočijo take odločitve in njihove obrazložitve drugim državam članicam in zainteresiranim stranem .
Such decisions , and the justifications therefor, shall be communicated by the competent authority to the other Member States and to the interested parties .
ČLEN 2, TOČKA 10 A (novo) Člen 15, odstavek 5 (Direktiva 93/42/EGS)
ARTICLE 2, POINT 10 A (new) Article 15, paragraph 5 (Directive 93/42/EEC)
(10a) Člen 15(5) se nadomesti z:
(10a) Article 15(5) is replaced by the following:
ČLEN 2, TOČKA 13 Člen 20, odstavek 1, pododstavek 2 (Direktiva 93/42/EGS)
ARTICLE 2, POINT 13 Article 20, paragraph 1, subparagraph 2 (Directive 93/42/EEC)
To ne vpliva na obveznosti držav članic in priglašenih organov v zvezi z vzajemnim obveščanjem in razširjenjem opozoril, niti na obveznost zadevnih oseb, da zagotovijo podatke v skladu s kazenskim pravom.
This does not affect the obligation of Member States and notified bodies with regard to mutual information and the dissemination of warnings, nor the obligations of the persons concerned to provide information under criminal law.
To ne vpliva na obveznosti držav članic in priglašenih organov v zvezi z vzajemnim obveščanjem in razširjenjem opozoril v skladu z določbami člena 10(1) , niti na obveznost zadevnih oseb, da zagotovijo podatke v skladu s kazenskim pravom.
This does not affect the obligation of Member States and notified bodies with regard to mutual information and the dissemination of warnings under the provisions of Article 10(1), nor the obligations of the persons concerned to provide information under criminal law.
Predloga spremembe odbora IMCO, vključen v besedilo brez glasovanja na podlagi člena 47.
IMCO amendment, which was incorporated in the report without vote on the basis of Rule 47.
Zaradi večje jasnosti se je priporočljivo sklicevati na prvi odstavek člena 10, ki navaja zaplete, do katerih pride po dajanju pripomočkov na trg.
For the sake and clarity it is advisable to refer to Article 10, paragraph 1 which mentions the incidents occurring following placing of devices on the market.
ČLEN 2, ODSTAVEK 14 A (novo)
ARTICLE 2, POINT 14 A(new)
Člen 21 a (novo) (Direktiva 93/42/EGS)
Article 21a (new) (Directive 93/42/EEC)
(14a) Doda se člen 21a:
(14a) The following Article 21a is inserted:
Člen 21a
"Article 21a
Evropski standard za ponovno predelavo
European reprocessing standard
Najkasneje ...* Komisija v skladu s postopkom iz člena 7 in po posvetovanju z Evropsko agencijo za zdravila določi natančna pravila o evropskem standardu za ponovno predelavo.
Not later than ...*, the Commission shall, in accordance with the procedure laid down in Article 7 and after consulting the European Medicines Agency (EMEA), establish detailed rules for a European reprocessing standard.
Ta pravila zagotavljajo znanstveno utemeljene tehnične smernice za ponovno predelavo uporabljenih medicinskih pripomočkov (za enkratno ali večkratno uporabo) in se redno posodabljajo zaradi zagotavljanja visoke stopnje varnosti bolnikov na podlagi načela previdnosti.
These rules shall provide scientifically based technical guidance for reprocessing of used (single or multiple use) medical devices and shall be updated regularly in order to ensure a high degree of patient safety based on the precautionary principle.
Za države članice, kjer nacionalna zakonodaja ne dovoljuje ponovne predelave ali uporabe ponovno predelanih medicinskih pripomočkov, se določijo podrobna pravila za obvezne preglede na kraju samem, ki jih izvajajo pristojni nacionalni organi.
For Member States whose national legislation does not authorise reprocessing or the use of re-processed medical devices, detailed rules for compulsory on-the-spot checks to be conducted by the competent national authorities shall be established.
Nacionalni organi zaradi pridobitve zanesljivih podatkov o nedovoljeni predelavi spremljajo tudi uporabo medicinskih pripomočkov v teh državah članicah, npr. z analizo razmerja med številom opravljenih zdravljenj ali operacij in številom prodanih/recikliranih/odstranjenih pripomočkov".
The national authorities shall monitor also the use of medical devices in those Member States, e.g. by analysing the ratio between treatments or surgeries performed and devices sold/recycled/disposed of in order to obtain reliable data on the amount of unauthorised reprocessing."
* Dve leti po začetku veljavnosti te direktive.
* Two years after the entry into force of this Directive.
Ponovna predelava uporabljenih medicinskih pripomočkov za enkratno ali večkratno uporabo je zelo razširjena v vseh državah članicah EU, tudi tam, kjer ni dovoljena.
Even when not legalised in a country, reprocessing of used medical devices for single or multiple-use is widespread practice in all EU-Member States.
Ker je nestrokovna ponovna predelava zelo nevarna za zdravje bolnikov (bolnišnične okužbe itd.), se zakonodajni organ poziva, da zagotovi smernice na področju ponovne predelave medicinskih pripomočkov.
As unprofessional reprocessing can cause serious risks for patients' health (hospital infections etc.), the legislator is asked to provide guidance for the reprocessing of medical devices.
PRILOGA I, TOČKA 1 (-A) (novo) Priloga I, oddelek 1 (Direktiva 90/385/EGS)
ANNEX I, POINT 1 (-A) (new) Annex I, section 1 (Directive 90/385/EEC)
(-a) Oddelek 1 se nadomesti z:
(-a) Section 1 is replaced by the following:
Pripomočki morajo biti načrtovani in izdelani tako, da njihova vsaditev v okviru predvidenih pogojev in namenov ne ogroža kliničnega stanja ali varnosti bolnikov in okolja.
The devices must be designed and manufactured in such a way that, when implanted under the conditions and for the purposes laid down, their use does not compromise the clinical condition or the safety of patients and the environment .
Za uporabnike pripomočkov ali,če je primerno, za druge osebe ne smejo predstavljati nikakršnega tveganja."
They must not present any risk to the persons implanting them or, where applicable, to other persons."
V luči pobude EU o "boljši pravni ureditvi", cilja o vključitvi okoljske zakonodaje v celotno zakonodajo skupnosti ter 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 the light of the EU initiative around Better Regulation, the objective to integrate environmental legislation in all community legislation, and in order to align these Directives with the EU Directive concerning medicines used in human beings to make more explicit the reference to the overall objectives being pursued by REACH already being integrated in these Directives.
V primeru neusklajenosti zakonodaj o REACH in o pripomočkih se vidikov zdravja, varnosti in okolja ne bi dalo skupaj oceniti glede na koristi za bolnika, kar bi nenadzorovano vplivalo na opravljanje medicinskih storitev in na dostop do zdravstvenega varstva.
Unless the devices and REACH legislations are integrated, the health and safety as well as the environmental aspects can not be weighed jointly against the patient benefit, which would impact medical practice and access to healthcare in an irrational way.
PRILOGA I, TOČKA 1 (-A A) (novo) Priloga I, oddelek 3 (Direktiva 90/385/EGS)
ANNEX I, POINT 1 (-A A) (new) Annex I, section 3 (Directive 90/385/EEC)
(-aa) Oddelek 3 se nadomesti z:
(-aa) Section 3 is replaced by the following:
Na lastnosti in delovanje iz oddelkov 1 in 2 ne sme priti do neugodnega učinka v takšni meri, da bi bila v roku trajanja pripomočka, ki ga je predvidel proizvajalec, ogrožena klinično stanje in varnost bolnikov ali, če je to primerno, drugih oseb ali okolja, povsod kjer je pripomoček izpostavljen obremenitvam, ki se lahko pojavijo pod normalnimi pogoji uporabe."
The characteristics and performances referred to in sections 1 and 2 must not be adversely affected to such a degree that the clinical condition and safety of the patients or, as appropriate, of other persons or the environment are compromised during the lifetime of the device anticipated by the manufacturer, where the device is subjected to stresses which may occur during normal conditions of use."
V luči pobude EU o "boljši pravni ureditvi", cilja o vključitvi okoljske zakonodaje v celotno zakonodajo Skupnosti ter 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 the light of the EU initiative around Better Regulation, the objective to integrate environmental legislation in all community legislation, and in order to align these Directives with the EU Directive concerning medicines used in human beings to make more explicit the reference to the overall objectives being pursued by REACH already being integrated in these Directives.
V primeru neusklajenosti zakonodaj o REACH in o pripomočkih se vidikov zdravja, varnosti in okolja ne bi dalo skupaj oceniti glede na koristi za pacienta, kar bi nenadzorovano vplivalo na opravljanje medicinskih storitev in na dostop do zdravstvenega varstva.
Unless the devices and REACH legislations are integrated, the health and safety as well as the environmental aspects can not be weighed jointly against the patient benefit, which would impact medical practice and access to healthcare in an irrational way.
PRILOGA I, TOČKA 1 (A)
ANNEX I, POINT 1 (A)
Priloga I, oddelek 9, alinea 7 (Direktiva 90/385/EGS)
Annex I, section 9, indent 7 (Directive 90/385/EEC)
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, je na področju programske opreme treba upoštevati načela razvojnega življenjskega cikla, obvladovanja tveganja, potrjevanja in preverjanja.
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 .
Koncept potrjevanja mora vedno temeljiti na ustrezni razvrstitvi zadevnega medicinskega pripomočka na podlagi tveganja.
The concept of validation should always be based on the relevant risk classification of the medical device concerned.
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.
Glede na načela za potrjevanje bi bilo treba upoštevati dejansko tveganje.
With regard to the principles of validation the existing real risk should be taken into account.
Zahteve glede programske opreme za robotske naprave v nevrokirurgiji bi bile nedvomno precej drugačne od zahtev glede programske opreme za UV luči za strjevanje smole v zobnih plombah.
The demands made regarding software for a robotic device in neurosurgery would undoubtedly be rather different from those made of software for a UV lamp for hardening resin in dental fillings.
PRILOGA I, TOČKA 1 (A A) (novo) Priloga I, oddelek 9 a (novo) (Direktiva 90/385/EGS)
ANNEX I, POINT 1 (A A) (new) Annex I, section 9a (new) (Directive 90/385/EEC)
(aa) Vstavi se oddelek 9a:
(aa) The following Section 9a is inserted:
Napake, ki bi se verjetno pojavljale pri vgrajevanju ali ponovnem vgrajevanju določenih delov in bi lahko bile vir tveganja, morajo biti onemogočene z načrtovanjem in izdelavo takšnih delov.
Errors likely to be made when fitting or refitting certain parts which could be a source of risk must be made impossible by the design and construction of such parts.
Enake informacije morajo biti podane o gibajočih se delih in njihovih ohišjih, kadar mora biti znana smer gibanja, da bi se izognili tveganju.
The same information must be given on moving parts and/or their housings where the direction of movement needs to be known in order to avoid a risk.
Po potrebi morajo navodila vsebovati dodatne informacije o tem tveganju.
Where necessary, the instructions must give further information on these risks.
Kadar je vir tveganja lahko napačna povezava, morajo biti nepravilne povezave preprečene z zasnovo ali, če to ne uspe, z informiranjem o elementih, ki se povezujejo, in, kadar je ustrezno, o načinu povezave.“
Where a faulty connection can be the source of risk, incorrect connections must be made impossible by design or, failing this, by information given on the elements to be connected and, where appropriate, on the means of connection."
Medicinski pripomočki, ki ohranjajo pri življenju, morajo izpolnjevati osnovna načela izdelave, kot to izrecno zahteva direktiva o strojih.
Life-preserving medical devices must also meet elementary construction principles as explicitly required in the Machinery Directive.
Glede na negativne izkušnje na tem področju je treba ta načela vključiti v to direktivo.
Given the negative experiences on the ground, these principles should be included in the present directive.
PRILOGA I, TOČKA 1 (B) Priloga I, oddelek 10 (Direktiva 90/385/EGS)
ANNEX I, POINT 1 (B) Annex I, Section 10 (Directive 90/385/EEC)