natgillin/translations-raw huggingface dataset:
Preden se sprejme odločitev o opredelitvi posameznega izdelka, je primerno, da se za predlog vpraša tudi proizvajalca v skladu z njegovo pravico do mnenja.
The manufacturer should therefore be fully associated in the context of his right to be heard before any decision is taken on the product definition.
Veliko kategorij izdelkov zajema širok razpon izdelkov, ki pa nimajo vedno enakih značilnosti ali niso predvideni za enako uporabo.
Many product categories cover a wide range of products that do not always have the same characteristics and purpose.
Odločitev mora biti zato vedno povezana s posameznim izdelkom.
Decisions should therefore always be taken on the basis of individual products.
Razen tega je predvidena uporaba, ki jo določi proizvajalec, bistven element opredelitve medicinskega pripomočka, zato morajo imeti proizvajalci pomembno vlogo pri postopkih odločanja.
Furthermore, the manufacturer's intended purpose is of integral importance in defining a medical device, which is why manufacturers should play an important role in the decision-making process.
14) Za zagotavljanje, da imajo organi, če proizvajalec nima registrirane poslovne enote v Skupnosti, eno samo osebo, ki jo je pooblastil proizvajalec, na katero se lahko obrnejo pri zadevah glede skladnosti pripomočkov z Direktivo, je treba za takšne proizvajalce uvesti obveznost imenovanja pooblaščenega predstavnika za vse razrede pripomočkov.
14) To ensure that, where a manufacturer does not have a registered place of business in the Community, authorities have a single individual person authorized by the manufacturer whom they can address in matters relating to the compliance of the devices with the Directives it is necessary to introduce an obligation for such manufacturers to designate an authorized representative for all classes of devices.
(14) Za zagotavljanje, da imajo organi, če proizvajalec nima registrirane poslovne enote v Skupnosti, eno samo osebo, ki jo je pooblastil proizvajalec, na katero se lahko obrnejo pri zadevah glede skladnosti pripomočkov z Direktivo, je treba za takšne proizvajalce uvesti obveznost imenovanja pooblaščenega predstavnika za vse razrede pripomočkov.
(14) To ensure that, where a manufacturer does not have a registered place of business in the Community, authorities have a single individual person authorized by the manufacturer whom they can address in matters relating to the compliance of the devices with the Directives it is necessary to introduce an obligation for such manufacturers to designate an authorized representative for all classes of devices.
Treba je poudariti, da mora vsak medicinski pripomoček, uvožen v Evropsko unijo, izpolnjevati določbe te direktive.
In this connection, it should be noted that any device imported into the European Union must comply with the rules laid down in this Directive.
Iz varnostnih razlogov mora vsak izdelek, uvožen v Skupnost, ustrezati predpisom, ki veljajo v Evropski uniji.
For safety reasons, any product imported into the Community should comply with the rules adopted within the European Union.
(15) Da se še naprej zagotavljata zdravje in varstvo ljudi, je treba zagotoviti bolj dosledno uporabo določb o ukrepih za varovanje zdravja.
(15) To further ensure public health and safety it is necessary to provide for a more consistent application of the provisions on health protection measures.
Zlasti je treba zagotoviti, da ob uporabi pripomočkov nista ogrožena varnost ali zdravje bolnikov.
Particular care should be taken to ensure that, when in use, the products do not endanger patients' safety or health.
Glede pogostosti uporabe mora za pripomočke veljati enotna evropska deklaracija.
As regards frequency of use, a uniform Europe-wide declaration of products should apply.
Razen tega je treba ukrepe za ponovno predelavo načeloma še naprej urejati na nacionalni ravni.
Reprocessing measures should in principle continue to be governed by national legislation.
Zagotoviti je treba, da se noben medicinski pripomoček hkrati ne deklarira za „enkratno uporabo“ v eni državi članici in za „večkratno uporabo“ v drugi državi članici.
It should be ensured that no medical device is simultaneously described as single-use in one Member State and multiple-use in another.
Razen tega morajo v primeru ponovne predelave veljati enotni higienski standardi.
Furthermore, in the event of reprocessing, there must be uniform hygiene standards.
(17) Za boljše usklajevanje uporabe in učinkovitosti nacionalnih virov, kadar se uporabljajo za vprašanja v zvezi z Direktivo 93/42/EGS, morajo države članice sodelovati med seboj in na mednarodni ravni.
(17) To better coordinate the application and efficiency of national resources when applied to issues related to Directive 93/42/EEC the Member States should cooperate with each other and at international level.
Da bi podjetjem omogočili konkurenčnost na svetovni ravni pod enakimi pogoji, bi bili potrebni mednarodna standardizacija in sodelovanje .
In order to enable industry to compete globally on equal terms, there should be international standardisation and cooperation .
Evropska industrija medicinskih pripomočkov prodaja svoje izdelke po vsem svetu.
The European medical devices industry sells its products world wide.
Zato so bolj zaželeni evropski standardi, ki temeljijo na mednarodnih postopkih standardizacije.
European standards, based on an international standardisation process, are therefore preferable.
Več truda bi bilo treba vložiti v spodbujanje mednarodnega sodelovanja, tako v obliki dvostranskih sporazumov kot manj formalnega sodelovanja (npr. delovna skupina za svetovno usklajevanje).
More effort should be made to promote international cooperation, both in the form of bilateral agreements, as via more informal cooperation (e.g. the Global Harmonization Task Force).
(18) Ker imajopobude oblik za varnost bolnikov vedno večjo vlogo v politiki javnega zdravja, je treba izrecno določiti potrebo po upoštevanju ergonomske oblike v bistvenih zahtevah.
(18) As design for patient safety initiatives play an increasing role in public health policy it is necessary to expressively set out the need to consider ergonomic design in the essential requirements.
Razen tega sta v bistvenih zahtevah nadalje poudarjena stopnja usposobljenosti in znanje uporabnika, kot v primeru uporabnika laika.
In addition the level of training and knowledge of the user, such as in the case of a lay user, is further emphasised within the essential requirements.
(18) Ker imajo pobude oblik za varnost bolnikov vedno večjo vlogo v politiki javnega zdravja, je treba izrecno določiti potrebo po upoštevanju ergonomske oblike v bistvenih zahtevah.
(18) As design for patient safety initiatives plays an increasing role in public health policy it is necessary to expressly set out the need to consider ergonomic design in the essential requirements.
Proizvajalec izdelka mora posebno pozornost posvetiti posledicam zlorabe izdelka in njegovim škodljivim učinkom na človeško telo.
The product manufacturer should place particular emphasis on the consequences of misuse of the product and its adverse effects on the human body.
Predlog spremembe poudarja pomen zdravja uporabnikov in njihove varnosti.
The amendment places the emphasis on user health and safety.
(21) Glede na naraščajoče izvajanje načrtovanja in izdelave pripomočkov s strani tretjih oseb v imenu proizvajalca, je pomembno, da proizvajalec dokaže, da izvaja ustrezne preglede tretjih oseb za nadaljnje zagotavljanje učinkovitega delovanja sistema kakovosti.
(21) In the light of the increased use of third parties to carry out the design and manufacture of devices on behalf of the manufacturer, it is important that the manufacturer demonstrates that he applies adequate controls to the third party to continue to ensure the efficient operating of the quality system.
Pristojni organi lahko tudi odločijo, da bodo sami neposredno izvedli pregled.
The competent authorities may also decide to apply controls directly.
Zaradi zagotavljanja najvišje možne stopnje varnosti morajo imeti organi možnost izvajanja pregledov.
In order to guarantee maximum safety, the authorities should be given the possibility of carrying out inspections.
( 21a) Pravila za ponovno predelavo medicinskih pripomočkov se med državami članicami zelo razlikujejo.
(21a) The rules on the reprocessing of medical devices differ widely from one Member State to another.
Komisija mora preučiti vpliv, ki ga imajo različna pravila na varnost bolnikov in stroškovno učinkovitost.
The Commission should study the impact which the different rules have on the protection of patients and cost-effectiveness.
Pred uvedbo kakršne koli zakonodaje je treba opraviti podrobno analizo.
A careful analysis should be made before any legislation on reprocessing is introduced.
(23a) V luči Sklepa 1999/468/ES z dne 28. junija o določitvi postopkov za uresničevanje Komisiji podeljenih izvedbenih pooblastil , ki uvaja regulativni postopek z nadzorom za splošne ukrepe, namenjene spreminjanju nebistvenih elementov osnovnega instrumenta, sprejetega s postopkom soodločanja, je treba ustrezno spremeniti Direktivo 90/385/EGS in Direktivo 93/43/EGS.
(23a) In the light of the introduction, by Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission 1 , of a regulatory procedure with scrutiny for measures of general scope designed to amend non-essential elements of a basic instrument adopted in co-decision, it is necessary to amend Directives 90/385/EEC and 93/43/EEC accordingly.
Regulativni postopek z nadzorom je treba uporabiti za sprejemanje predlogov sprememb k prilogam Direktive 93/43/EGS, sklepov v zvezi z razvrščanjem medicinskih pripomočkov in sklepov v zvezi z umikom medicinskih pripomočkov za vsaditev iz prometa oziroma prepovedjo ali omejevanjem njihovega dajanja v promet.
Regulatory procedure with scrutiny should apply to the adoption of amendments to the Annexes to Directive 93/43/EEC, decisions with regard to classification of medical devices and decisions to withdraw from the market or prohibit or restrict the placing on the market of implantable medical devices.
Sklep, kakor je bil nazadnje spremenjen z odločbo Sveta 2006/512/ES (UL L 200, 22.7.2006, str.
Decision as amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, p.
Predlog spremembe je potreben, da bi besedilo uskladili z določbami iz novega "komitološkega" sklepa in zlasti da bi navadni postopek "regulativnega odbora" zamenjali s postopkom "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 replace the ordinary "regulatory committee" procedure with the "regulatory committee with scrutiny", since the measures concerned are measures of general scope designed to amend non-essential elements of the draft legislation.
Našteti so ukrepi, ki bi jih moral zajemati novi postopek.
It lists the measures that should be covered by the new procedure.
ČLEN 1, TOČKA 1 (A) (I)
ARTICLE 1, POINT 1 (A) (I)
Člen 1, odstavek 2, točka (a), uvodni del (Direktiva 90/385/EGS)
Article 1, paragraph 2, point (a), introductory part (Directive 90/385/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, namenjeno izrecno diagnosticiranju in/ali za terapevtske namene in 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 intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
V ta člen je treba vključiti le programsko opremo za diagnostične in terapevtske namene in ne vse programske opreme.
Only diagnostic and therapeutic software should be included in this Article and not all software as such.
ČLEN 1, TOČKA 1 (D) Člen 1, odstavek 4 b (Direktiva 90/385/EGS)
ARTICLE 1, POINT 1(D) Article 1, paragraph 4b (Directive 90/385/EEC)
Če pripomoček, kot sestavni del, vsebuje snov, ki lahko velja, če se uporablja ločeno, za izdelek iz človeških tkiv v smislu [člena 2(2) Uredbe (ES) št. […] Evropskega parlamenta in Sveta(**) [o naprednih terapijah in spremembi Uredbe (ES) št 726/2004]] in ki ima verjetno ob tem medicinskem pripomočku na telo dopolnilni učinek , se mora ta pripomoček oceniti in odobriti v skladu s to direktivo .
Where a devices incorporates, as an integral part, a substance, which, if used separately, may be considered to be a human tissue engineered product within the meaning of [Article 2 (2) of the Regulation (EC) No […] of the European Parliament and of the Council (**) [on advanced Therapies and amending Regulation (EC) No 726/2004]] and which is liable to act upon the body with action that is ancillary to that of the device, that device must be assessed and authorized in accordance with this Directive .
Če pripomoček, kot sestavni del, vsebuje snov, ki lahko velja, če se uporablja ločeno, za izdelek iz človeških tkiv v smislu [člena 2(2) Uredbe (ES) št. […] Evropskega parlamenta in Sveta(**) [o naprednih terapijah in spremembi Uredbe (ES) št 726/2004]], se mora ta pripomoček oceniti in odobriti v skladu s to uredbo .
Where a devices incorporates, as an integral part, a substance which, if used separately, may be considered to be a human tissue engineered product within the meaning of [Article 2 (2) of Regulation (EC) No […] of the European Parliament and of the Council (**) [on advanced Therapies and amending Regulation (EC) No 726/2004]], that device must be assessed and authorized in accordance with that Regulation .
Izdelki, ki veljajo za izdelke iz človeških tkiv, vsebujejo dele tkiv ali celic, ki bodo nadomestile, popravile ali obnovile človeško tkivo.
Products which are considered as Tissue Engineered Products contain parts of tissues or cell which shall replace, repair or regenerate human tissue.
Ti izdelki so torej zelo občutljivi, vzajemno delujejo z živimi celicami in bi jih morala urejati farmacevtska zakonodaja.
Thus, those products are very sensitive and interacting with living cells and should fall under the pharmaceutical legislation.
ČLEN 1, TOČKA 1 A (new) Člen 2 (Direktiva 90/385/EGS)
ARTICLE 1, POINT 1 A (new) Article 2 (Directive 90/385/EEC)
(1a) Člen 2 se nadomesti z:
(1a) Article 2 is replaced by the following:
„Člen 2
“ Article 2
Države članice sprejmejo vse potrebne ukrepe, da zagotovijo, da se lahko pripomočki dajo na trg in/ali v uporabo le, če izpolnjujejo zahteve, določene v tej direktivi, ter če so dostavljeni, nameščeni, vzdrževani in uporabljeni ustrezno in v skladu z njihovim predvidenim namenom.
Member States shall take all necessary steps to ensure that devices may be placed on the market and/or put into service only if they comply with the requirements laid down in this Directive when duly supplied and properly installed, maintained and used in accordance with their intended purpose.
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.”
Prodaja kontaktnih leč prek 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 okulista, morebitno nevarnost za zdravje evropskih državljanov.
Sales of contact lenses 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 eye care practitioners.
V skladu s členom 1521 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 1, TOČKA 2 (A A) (novo) Člen 6, odstavek 2 a (novo) (Direktiva 90/385/EGS)
ARTICLE 1, POINT 2 (A A) (new) Article 6, paragraph 2 a (new) (Directive 90/385/EEC)
(aa) Vstavi se odstavek 2a:
(aa) The following paragraph 2a is inserted:
Pri sklicevanju na ta odstavek se uporabljata člena 5a in 7 Sklepa 1999/468/ES."
Where reference is made to this paragraph, Articles 5a and 7 of Decision 1999/468/EC shall apply."
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 zadevni ukrepi 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 measures concerned are measures of general scope designed to amend non-essential elements of the draft legislation.
Člen 10 a, odstavek 2, pododstavek 2 (Direktiva 90/385/EGS)
Article 10a, paragraph 2, subparagraph 2 (Directive 90/385/EEC)
Za pripomočke iz odstavka 1 pooblaščeni zastopnik pristojne organe v državi članici, v kateri ima registrirano poslovno enoto, obvesti o naslovu registrirane poslovne enote in kategoriji zadevnih pripomočkov.
For devices referred to in paragraph 1 the authorized representative shall inform the competent authorities of the Member State in which he has his registered place of business of the address of the registered place of business and the category of devices concerned.
Elektronski postopek je dovolj.
This may be done electronically.
Razen tega mora biti pooblaščeni zastopnik na voljo za posvetovanje.
The authorized representative should also be available to answer any queries.
Vsak medicinski pripomoček, uvožen v Evropsko unijo, mora spoštovati določbe te direktive.
Any medical device imported into the European Union shall comply with the rules laid down in this Directive.
Naloge pooblaščenega zastopnika morajo biti čim jasneje določene.
The role of the authorized representative should be defined as clearly as possible.
Iz varnostnih razlogov mora vsak izdelek, uvožen v Skupnost, spoštovati predpise, ki veljajo v Evropski uniji.
For safety reasons, any product imported into the Community should comply with the rules adopted within the European Union.
ČLEN 1, TOČKA 3 Člen 10 c, odstavek 4 (Direktiva 90/385/EGS)
ARTICLE 1, POINT 3 Article 10c, paragraph 4 (Directive 90/385/EEC)
Če so nacionalni ukrepi upravičeni, sprejme Komisija potrebne ukrepe na ravni Skupnosti v skladu s postopkom iz člena 6(2) .
Where the national measures are justified, the Commission shall adopt the necessary Community measures in accordance with the procedure referred to in Article 6(2).
Če nacionalni ukrepi niso upravičeni, obvesti Komisija vse države članice in zadevne vpletene strani.
In case 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 6(2a) .
Where the national measures are justified, the Commission shall adopt the necessary Community measures in accordance with the procedure referred to in Article 6(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 nekaterih 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 some the measures concerned are measures of general scope designed to amend non-essential elements of the draft legislation.
ČLEN 2, TOČKA -1 (novo) Uvodna izjava 7 (Direktiva 93/42/EGS)
ARTICLE 2, POINT -1 (new) Recital 7 (Directive 93/42/EEC)
(-1a) Uvodna izjava 7 se nadomesti z:
(-1) Recital 7 is replaced by the following:
"Ker je treba bistvene zahteve in druge zahteve, določene v prilogah k tej direktivi, vključno z vsakim sklicevanjem na 'zmanjšanje tveganja na minimum' ali 'zmanjšanje tveganja', razumeti in uporabljati na takšen način, da bodo upoštevani najboljši izdelki, tehnologija in praksa, ki so na voljo na področju oblikovanja, ter tehnični in ekonomski vidiki, skladni z visoko ravnjo zaščite zdravja in varnosti."
"Whereas the essential requirements and other requirements set out in the Annexes to this Directive, including any reference to 'minimizing' or 'reducing' risk, must be interpreted and applied in such a way as to take account of best available products, technology and practice in design and of technical and economic considerations compatible with a high level of protection of health and safety."
Uvodno izjavo je treba posodobiti.
The recital needs to be updated.
Bistvene zahteve morajo ustvariti pobudo za izboljšanje oblikovnih rešitev in bi morale zato namesto na zastarelih temeljiti na najboljših oblikovnih rešitvah, ki so na voljo.
Essential requirements must create an incentive to improve design and should therefore be based on best available design, rather than "grandfather in" old design.
ČLEN 2, TOČKA 1 (A) (I) Člen 1, odstavek 2, točka (a), uvodni stavek (Direktiva 93/42/EGS)
ARTICLE 2, POINT 1 (A) (I) Article 1, paragraph 2, point (a), introductory phrase (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:
V ta člen je treba vključiti le programsko opremo za diagnostične in terapevtske namene in ne vse programske opreme.
Only diagnostic and therapeutic software should be included in this article and not all software as such.
Vključitev besedne zveze ‚za medicinske namene‘ bi lahko povzročila izključitev nekaterih izdelkov iz direktive (ne velja za slovensko različico – op. p.).
The addition of the phrase 'for medical purposes' might allow certain products to be excluded from the Directive.
To bi povzročilo negotovost med uporabniki in pojavila bi se možnost, da se na bolnikih uporabljajo nenadzorovani izdelki.
This would create uncertainty among users and has a potential for uncontrolled products to be used on patients.