natgillin/translations-raw huggingface dataset:
Priloga VIII, oddelek 5, uvodni odstavek (Direktiva 93/42/EGS)
Annex VIII, section 5, introductory paragraph (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, takoj ko zanje izve:
This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:
Za uporabniku prilagojene pripomočke mora proizvajalec jamčiti, da bo ocenil izkušnje, pridobljene v fazi po proizvodnji, in da bo uporabljal ustrezna sredstva za uveljavljanje vseh potrebnih korektivnih postopkov.
For custom-made devices, the manufacturer must undertake to review experience gained in the post-production phase 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, skorajšnjih 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, near incidents and the relevant corrective action immediately on learning of them:
Proizvajalci uporabniku prilagojenih pripomočkov lahko najbolje sledijo svojim pripomočkom, ker je bolnik imenovan.
Manufacturers of custom-made devices are best able to trace their products, as the patients in question are known by name.
Zahtevani sistematični postopki (uvedba ISO 13485) pomenijo 2000–5000 EUR dodatnih stroškov na leto za zobne tehnike, optike, izdelovalce slušnih aparatov, izdelovalce ortopedske obutve itd.
The systematic procedure called for here (the introduction of ISO 13485) means additional annual costs for dental technicians, opticians, hearing aid and orthopaedic shoe technicians etc. of between EUR 2000 and 5000.
To ni upravičeno, ker splošna formulacija prav tako odvrača tveganje.
This cannot be justified, as a general wording will also avert risks.
PRILOGA II, TOČKA 9 (B)
ANNEX II, POINT 9 (B)
Priloga IX, poglavje II, oddelek 2.6 (Direktiva 93/42/EGS)
Annex IX, chapter II, section 2.6 (Directive 93/42/EEC)
Pri izračunu trajanja iz oddelka 1.1 poglavja I pomeni neprekinjena uporaba nemoteno dejansko uporabo pripomočka za predvideni namen.
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.
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.
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 se lahko dokaže, da takšna zamenjava odpravlja 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 the risks arising from a continued use of the device.
Sedanji predlog lahko vpliva na razvrstitev nekaterih izdelkov tako, da jih uvrsti v višji razred, kar ni utemeljeno, ker trajanje stika med pripomočkom in bolnikom ni edini dejavnik za določitev razvrstitve tveganja.
The current proposal may affect the classification of several products by putting these in a higher class, which is not justifiable as the duration of contact between a device and a patient is not the unique factor for determining the risk classification.
Določitev trajanja stika med pripomočkom in bolnikom mora biti povezana z analizo tveganja, ki izhaja iz takšnega stika.
The determination of the duration of the contact between the device and the patient should be linked to the analysis of the risks posed by such contact.
PRILOGA II, TOČKA 9 (C) (VII) Priloga IX, poglavje III, oddelek 4.4 (Direktiva 93/42/EGS)
ANNEX II, POINT 9 (C) (VII) Annex IX, Chapter III, 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:
(vii) Section 4.4. is replaced by the following:
"4.4 Pravilo 16
"4.4 Rule 16
"Pripomočki, posebej namenjeni snemanju rentgenskih diagnostičnih posnetkov, so v razredu IIa."
Devices specifically intended for recording of X-Ray diagnostic images are in Class IIa.
Opomba: to velja za primarne snemalne naprave, kot so rentgenski detektorji, in ne za naprave, ki se uporabljajo za kasnejše reproduciranje ali shranjevanje."
Note: this refers to primary recording media such as X-ray detectors and not to media used for subsequent reproduction or storage."
Namen tega dodatka je preprečiti preširoko uporabo omejevalnih zahtev.
This addition is intended to prevent the excessively wide application of restrictive requirements.
1.1.1. kritičnem vrednotenju ustrezne znanstvene literature, ki je zdaj na voljo v zvezi z varnostjo, delovanjem, načrtovalnimi lastnostmi in predvidenim namenom pripomočka, če:
1.1.1. either a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device, where:
– obstaja dokazilo o enakovrednosti pripomočka s pripomočkom, za katerega veljajo podatki, in
— there is demonstration of equivalence of the device to the device to which the data relates and,
– obstaja dokazilo o enakovrednosti funkcij, indikacij, razmerja koristi/tveganja in pričakovane terapevtske učinkovitosti pripomočka s pripomočkom, za katerega veljajo podatki, in
— there is demonstration of equivalence of the functions, indications, benefit/risk ratio and therapeutic efficacy expected of the device to the device to which the data relates and,
- podatki ustrezno dokazujejo skladnost z ustreznimi bistvenimi zahtevami;
— the data adequately demonstrate compliance with the relevant essential requirements;
1.1.2. ali kritičnem vrednotenju rezultatov vseh opravljenih kliničnih preiskav;
1.1.2. or a critical evaluation of the results of all clinical investigations made;
1.1.3. ali kritičnem vrednotenju združenih kliničnih podatkov iz 1.1.1 in 1.1.2.
1.1.3. or a critical evaluation of the combined clinical data provided in 1.1.1 and 1.1.2.
1.1.3. ali kritičnem vrednotenju združenih kliničnih podatkov iz 1.1.1 in 1.1.2 in rezultatov biofizičnih raziskav ali raziskav modelov, katerih ustreznost mora biti predhodno dokazana.
1.1.3. or a critical evaluation of the combined clinical data provided in 1.1.1 and 1.1.2 and the results of biophysical or modelling research whose validity has been demonstrated beforehand .
K odstavku 1.1.1: Treba je natančno določiti, na katerih pomembnih merilih za klinično vrednotenje temelji pojem enakovrednosti.
Under sub-section 1.1.1: It needs to be specified which criteria of importance to the clinical evaluation are covered by the equivalence.
K odstavku 1.1.3: Ta predlog spremembe omogoča izvajanje predloga spremembe 2 zgoraj navedenega člena 2.
Under sub-section 1.1.3: This amendment enables Amendment 2 under Article 2 (above) to be applied.
Te nove tehnologije, največkrat vezane na virtualno stvarnost, imajo lahko pomembno vlogo.
These new technologies, generally linked to virtual reality, may make a significant contribution.
Omogočajo preučitev vseh možnih oblik in predvidevanje učinkov, ki jih lahko pričakujemo od medicinskega pripomočka.
They have the advantage of being able to consider all possible scenarios and thus to predict what effects can be expected of a medical device.
Predlog, ki ga je podala Evropska komisija o reviziji Direktive 83/42/EGS o medicinskih pripomočkih, Direktive 90/385/EGS o približevanju zakonodaje držav članic o aktivnih medicinskih pripomočkih za vsaditev in o prilagoditvi Direktive 98/79/ES, je treba načeloma pozdraviti.
The proposal put forward by the Commission amending Directive 93/42/EEC concerning medical devices and Directive 90/385/EEC concerning active implantable medical devices and adapting Directive 98/79/EC is to be welcomed in principle.
Vendar pa so se v podrobnejši nadaljnji obravnavi pokazale različne slabosti, ki jih je treba v nadaljevanju v okviru naslednjega poročila odpraviti.
However, closer inspection reveals various weaknesses, which are addressed below.
Povzete so ključne točke.
In brief, the key points are as follows:
Določitev meje glede na druge direktive
Differentiation from other directives
Za nemoteno in nebirokratsko izvajanje Direktive s strani organov je treba jasno določiti mejo glede na druge zakone in jasno opredeliti medicinski pripomoček.
To ensure that the authorities can transpose the Directive smoothly and without bureaucracy, it is crucial to distinguish clearly between this and other laws and for there to be an unambiguous definition of medical devices.
Ta direktiva se mora čim manj prekrivati z drugimi direktivami in uredbami.
There should be as little overlapping with other directives and regulations as possible.
Poročevalcu se zdi pomembno najti jasno rešitev ob upoštevanju poročila o naprednih terapijah, ki tudi čaka na obravnavo v Parlamentu.
In particular, it was important to the rapporteur to find a clear-cut solution in relation to the report on 'Advanced Therapies', which is likewise currently awaiting Parliament's consideration.
Ravno tako je treba rešiti vprašanje kombiniranih izdelkov, torej pripomočkov, ki vsebujejo človeško ali živalsko tkivo skupaj materialnimi sestavnimi deli.
The issue of combined products, i.e. devices which contain both human or animal tissue and material components, needed to be dealt with.
V dogovoru s poročevalcem o naprednih terapijah bodo kot medicinski pripomočki opredeljeni in v skladu s to direktivo ocenjeni le tisti izdelki, ki vsebujejo tkiva in celice, ki niso sposobne živeti, in ki imajo ob pripomočku na človeško telo dopolnilni učinek.
In agreement with the rapporteur on 'Advanced Therapies', only those products will be classified as medical devices which do not contain any viable tissue and cells and which are liable to act upon the body with action that is ancillary to that of the device: these will be assessed in accordance with the directive at issue.
Jasni kriteriji odločanja za razvrstitev izdelkov
Clear decision-making criteria for the classification of products
Organi morajo imeti možnost, da za posamezne izdelke brez težav določijo, katera direktiva velja zanje.
It must be possible for the authorities to match individual products to the directives governing them without difficulty.
Zato je primerno, da se v Direktivo 93/42/EGS vključi dodatna priloga s seznamom posameznih izdelkov, na podlagi katerih se lahko težja razvrstitev izvede jasno in nebirokratsko.
It is useful, therefore, for an additional annex to Directive 93/42/EEC to contain a list of information on individual products to aid the difficult task of classifying products in a clear and unbureaucratic way.
Eno bistvenih vprašanj je bilo tudi, ali je treba "programsko opremo samo po sebi" opredeliti kot medicinski pripomoček.
One very vital issue was whether 'software in its own right' should be defined as a medical device or not.
Po obširni razpravi se je izkazalo, da se mnenji Komisije in Parlamenta o tem vprašanju bistveno ne razlikujeta.
After much debate, it became clear that there was no fundamental difference of opinion between the Commission and Parliament on this subject.
Končno se je poročevalec odločil zapisati pomembno pojasnilo v uvodni izjavi:
In the end, the rapporteur decided to make the vital clarification in a recital:
"Treba je pojasniti, da je programska oprema sama po sebi, kadar jo proizvajalec posebej nameni za uporabo v enega ali več medicinskih namenov, določenih v opredelitvi medicinskega pripomočka, medicinski pripomoček."
'It is necessary to clarify that software in its own right, when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device, is a medical device.
"Programska oprema za splošne namene, ki se uporablja v zdravstvenem okolju, ni medicinski pripomoček."
Software for general purposes when used in a healthcare setting is not a medical device.'
V dogovoru s Komisijo je tako tudi postalo jasno, da je treba s seznama v členu 1(2a) Direktive 93/42/EGS črtati besedo "programska oprema".
Thus it also became clear in agreement with the Commission that the word 'software' needed to be deleted from the list in Article 1(2)(a) of Directive 93/42/EEC.
Sicer bi se lahko zgodilo, da bi npr. elektronske zdravstvene kartice postale medicinski pripomoček, saj vsebujejo programsko opremo.
Otherwise, there would be a danger that for example electronic health cards might suddenly become medical devices on the grounds that they contain software.
Tako bi bilo v prihodnje v zdravniških ambulantah treba certificirati tudi preproste programe Word in Excel.
It would also become necessary in future to certify Excel or Word programmes at doctors' practices.
Temeljno politično vprašanje v razpravi o direktivi o medicinskih pripomočkih je bila ponovna predelava medicinskih pripomočkov.
The fundamental political issue in the debate concerning the Medical Device Directive was the reprocessing of medical devices.
Sedaj veljavna direktiva tega področja ne določa.
The directive currently in force does not contain any provisions on this subject.
Vprašanje torej urejajo države članice skladu s subsidiarnostjo.
The matter has therefore been regulated, in accordance with subsidiarity, in the Member States.
V Nemčiji je ponovna predelava možna, vendar je treba pri tem upoštevati določene procese, ki jih je svojih smernicah povzel Inštitut Roberta Kocha.
In Germany, reprocessing is possible.
Ponovna predelava izdelkov za enkratno uporabo v osnovi tako ni prepovedana.
However, certain processes have to be adhered to for the purpose, which are summarised in guidelines issued by the Robert Koch Institute.
Za razliko od izdelkov za večkratno uporabo pa nosi odgovornost za pravilno delovanje predelovalec, kakor če bi sam naredil izdelek.
However, if they are reprocessed, then – unlike in the case of multiple-use devices – responsibility for ensuring that they work properly is transferred to the reprocessor as if he had produced the device himself.
Poročevalec želi glede ponovne predelave ohraniti ureditev s subsidiarnostjo.
The rapporteur would like to retain the subsidiarity-based provisions concerning reprocessing.
Kontaktne leče
Contact lenses
Poročevalec se je odločil, da kontaktnih leč za povsem kozmetične namene ne bo vključil v direktivo o medicinskih pripomočkih, da bi se izognili precedensu, npr. pri piercingu.
In order to avoid creating a precedent, for example for piercings, the rapporteur decided that purely cosmetic contact lenses should not fall under the Medical Device Directive.
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
Predlog je torej upravičen, saj je potrebno boljše izvajanje obstoječih pravil.
As far as the scope of the Directive is concerned, the Draftsperson supports the Commission's view not to include the reprocessing of medical devices in this regulatory reform.
Kar zadeva področje uporabe direktive, pripravljavka mnenja podpira stališče Komisije, da predelava medicinskih pripomočkov ne bo vključena v to regulativno reformo, vseeno pa Komisijo poziva, naj razmisli o nadaljnjem zakonodajnem delu na tem področju, po ustreznem premisleku in posvetovanju.
However, she calls on the Commission to consider future legislative work in this area, after a due reflection and consultation.
Težava pri opredelitvi izraza „medicinski pripomoček“ je, da lahko neki izdelek sodi na področje uporabe te direktive, hkrati pa tudi drugih direktiv, na primer o zdravilih ali kozmetiki.
A problem with the definition of "medical device" may be that a particular product falls under the definition of this Directive and at the same time within the scope of other directives, e.g. medicinal products, cosmetics etc.
V takem primeru je treba veljavno direktivo določiti na podlagi ocene, kateri je glavni predvideni namen ter z njim povezano ustrezno delovanje in učinek izdelka.
In this case, the determination of the applicable Directive should be based on the evaluation of the principal intended purpose and the related relevant functioning and impact of the product.
Osrednji namen predlogov sprememb je povečati varnost bolnikov in javno zdravje, pa tudi varnost in kakovost snovi.
The main goal of the amendments proposed is to strengthen the aspects of patient safety and public health as well as the safety and quality of substances.
Pripravljavka mnenja zato v nekaterih členih predlaga jasnejše izraze, ki bodo vpletenim interesnim skupinam zagotovili večjo pravno varnost.
In order to meet these goals, the Draftsperson in some articles pleads for a clearer wording which should lead to a greater legal certainty for the involved stakeholders.
V prid varnosti bolnikov pa poudarja zahtevo, da morajo biti generični proizvodi razvrščeni v isto kategorijo kot izvirni in da mora zanje veljati tudi enaka zakonodaja.
In respect of patient safety, the Draftsperson aims to give emphasis to the demand that copy products should fall under the same category and legislation as the original product.
Odbor za notranji trg in varstvo potrošnikov poziva Odbor za okolje, javno zdravje in varnost hrane kot pristojni odbor, da v svoje poročilo vključi naslednje predloge sprememb:
The Committee on the Internal Market and Consumer Protection calls on the Committee on the Environment, Public Health and Food Safety, as the committee responsible, to incorporate the following amendments in its report:
(2b) Komisija mora poleg tega v dveh mesecih od sprejetja Direktive pred pristojnimi odbori Evropskega parlamenta poročati o napredku na tem področju.
(2b) The Commission should also appear before the relevant committees of the European Parliament within two months of the date of adoption of this Directive to report on progress made in this area.
(2c) Kontaktne leče, ki nimajo korekcijskega učinka in se uporabljajo za spreminjanje videza oči, ne veljajo za medicinski pripomoček za namene te direktive.
(2c) Non-corrective contact lenses which are used to change the appearance of the eye are not regarded as medical devices for the purposes of this Directive.
RECITAL 2 D (novo)
RECITAL 2 D (new)
(2d) Komisija mora preučiti trenutni prodajni in distribucijski sistem kontaktnih leč v državah članicah, oceniti možno nevarnost za zdravje in varnost potrošnikov ter sprejeti ustrezne zakonodajne in nezakonodajne ukrepe, da bi zagotovila visoko raven varovanja zdravja v Skupnosti.
(2d) The Commission should investigate the current sale and distribution system of contact lenses in Member States, evaluate the potential risks to the health and safety of consumers and take the appropriate measures, legislative or non-legislative, in order to ensure a high level of health protection in the Community.
Poročilo o teh ugotovitvah in morebitnih ukrepih je treba predstaviti pristojnim odborom Evropskega parlamenta v šestih mesecih po sprejetju Direktive.
A report of such findings and any eventual proceedings should be presented to the relevant committees of the European Parliament within six months of the adoption of this Directive.
(6) Treba je pojasniti, da je obravnavanje izdelka, ki ima medicinski namen, bistveno za opredelitev medicinskega pripomočka in da je programska oprema sama po sebi opredeljena kot medicinski pripomoček.
(6) It is necessary to clarify that consideration of a product having a medical purpose is intrinsic to the definition of a medical device and that software in its own right can be defined as a medical device.
Programa (kot takega) ni mogoče opredeliti kot medicinski pripomoček.
The program itself (as such) could not be a medical device
(15) Da se še naprej zagotavljata zdravje in varstvo ljudi, je treba zagotoviti bolj dosledno uporabo določb o ukrepih za varovanje zdravja , še posebej pa poskrbeti, da pripomočki med uporabo ne ogrožajo varnosti ali zdravja bolnikov .
(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 , and in particular make sure that the devices do not risk compromising the safety or health of patients at the time of use .
Države članice so zaradi skrbi za javno zdravje odgovorne za pravilno uporabo pripomočkov na svojem ozemlju skozi celotno življenjsko dobo pripomočka.
For public health reasons, Member States have the responsibility to ensure proper use of the devices on their territory during the device life-time.
(20) Ob upoštevanju naraščajočega pomena programske opreme na področju medicinskih pripomočkov, ne glede na to, ali gre za samostojno programsko opremo ali programsko opremo, vgrajeno v pripomoček, mora preverjanje ustreznosti programske opreme v skladu s tehničnim razvojem postati bistvena zahteva.
(20) Taking account of the growing importance of software in the field of medical devices, be it as stand alone or as software incorporated in a device, validation of software in accordance with the state of the art should be an essential requirement.
ČLEN 1, TOČKA (1)(a)(i)
ARTICLE 1, POINT (1), POINT (A), POINT (I)
(a) ‚medicinski pripomoček‘ je vsak instrument, aparatura, naprava, programska oprema , material ali drug predmet, ki se uporablja samostojno 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, together with any accessories, 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‘ je vsak instrument, aparatura, naprava, material ali drug predmet, ki se uporablja samostojno 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, together with any accessories, 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 1, TOČKA (1a) (novo) Člen 2 (Direktiva 90/385/EGS)
ARTICLE 1, POINT (1 A) (new) Article 2 (Directive 90/385/EEC)