natgillin/translations-raw huggingface dataset:
The guidance provided for the ex-ante economic replicability test referred to in point 56 and in the present Annex is limited to the scope of this Recommendation, which relate to the application of Articles 15 and 16 of Directive 2002/21/EC together with Articles 10 and 13 of Directive 2002/19/EC, and therefore applies in different circumstances than ex-ante margin squeeze tests applied on regulated wholesale access prices and is entirely without prejudice to application of the competition rules by the Commission and/or national competent authorities, and to their interpretation by the General Court and the Court of Justice of the European Union.
Smernice za predhodni preskus gospodarske ponovljivosti iz točke 56 in te priloge so omejene na namene tega priporočila, ki je povezano z uporabo členov 15 in 16 Direktive 2002/21/ES, skupaj s členoma 10 in 13 Direktive 2002/19/ES, zato se uporablja v drugačnih pogojih kot predhodni preskusi cenovnih škarij, ki se uporabljajo za regulirane veleprodajne cene dostopa, in v ničemer ne posega v konkurenčna pravila, ki jih uporabljajo Komisija in/ali pristojni nacionalni organi, ter razlago pravil, ki jo zagotavljata Splošno sodišče in Sodišče Evropske unije.
This guidance is also without prejudice to any action that the Commission may take or any guidelines that the Commission may issue in the future with regard to the application of competition law in the Union.
Te smernice tudi ne posegajo v noben ukrep, ki ga lahko Komisija sprejme, in nobene smernice, ki jih lahko Komisija izda glede uporabe konkurenčnega prava v Uniji.
Given that NRAs should implement the recommended costing methodology, and therefore operators need to adapt their business plans accordingly, a transitional period until 31 December 2016 is considered appropriate.
Ob upoštevanju, da bi morali NRO izvesti priporočeno metodologijo za izračun stroškov in da morajo zato operaterji ustrezno prilagoditi svoje poslovne načrte, se zdi primerno prehodno obdobje do 31. decembra 2016.
NRAs are not required to maintain cost models for calculating wholesale copper access prices in circumstances when there is no ex-ante price regulation imposed, for example absent demand for such services.
NRO ni treba ohranjati modelov stroškov za izračunavanje veleprodajnih cen stroškov bakrenih omrežij v razmerah, kjer predhodna regulacija cen ne obstaja, na primer zaradi pomanjkanja povpraševanja po takšnih storitvah.
of 24 September 2013
z dne 24. septembra 2013
on the audits and assessments performed by notified bodies in the field of medical devices
o revizijah in ocenah, ki jih opravljajo priglašeni organi na področju medicinskih pripomočkov
The proper functioning of notified bodies is crucial for ensuring a high level of health and safety protection, the free movement of medical devices in the internal market, and citizens’ confidence in the regulatory system.
Pravilno delovanje priglašenih organov je bistveno za zagotavljanje visoke ravni varovanja zdravja in varnosti, prostega pretoka medicinskih pripomočkov na notranjem trgu ter zaupanja državljanov v regulativni sistem.
Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices [1], Council Directive 93/42/EEC of 14 June 1993 concerning medical devices [2], and Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices [3], contain certain provisions with regard to the audits, assessments and unannounced audits performed by notified bodies in the field of medical devices.
Direktiva Sveta 90/385/EGS z dne 20. junija 1990 o približevanju zakonodaje držav članic o aktivnih medicinskih pripomočkih za vsaditev [1], Direktiva Sveta 93/42/EGS z dne 14. junija 1993 o medicinskih pripomočkih [2] ter Direktiva 98/79/ES Evropskega parlamenta in Sveta z dne 27. oktobra 1998 o in vitro diagnostičnih medicinskih pripomočkih [3] vsebujejo nekatere določbe glede revizij, ocen in nenapovedanih revizij, ki jih opravljajo priglašeni organi na področju medicinskih pripomočkov.
The interpretation of those provisions and the behaviour of notified bodies designated in the field of medical devices differ.
Razlaga teh določb in ravnanje priglašenih organov, imenovanih na področju medicinskih pripomočkov, se razlikujeta.
Therefore this Recommendation should set benchmarks for assessments and unannounced audits by notified bodies and respond to the most frequent shortcomings of the current practices.
Zato bi bilo treba s tem priporočilom določiti merila uspešnosti za ocene in nenapovedane revizije, ki jih opravljajo priglašeni organi, ter se odzvati na najpogostejše pomanjkljivosti v sedanjih praksah.
The Recommendation aims at ensuring that the notified body carries out a proper verification of the fulfilment of the legal requirements by the manufacturer.
Namen Priporočila je zagotoviti, da priglašeni organ ustrezno preverja, ali proizvajalec izpolnjuje zakonske zahteve.
Subject to the respective conformity assessment procedure, notified bodies perform product assessments or quality system assessments.
Priglašeni organi ob upoštevanju ustreznega postopka ocenjevanja skladnosti opravljajo ocene izdelkov ali ocene sistemov kakovosti.
Accordingly, it is important to differentiate between these two types of assessments.
Skladno s tem je pomembno razlikovati med navedenima vrstama ocene.
To verify the continuous compliance with legal obligations, notified bodies should perform unannounced audits in addition to product assessments and quality system assessments.
Zaradi preverjanja stalne skladnosti z zakonskimi obveznostmi bi morali priglašeni organi poleg ocen izdelkov in ocen sistemov kakovosti opravljati nenapovedane revizije.
In order to satisfy the legal requirements laid down in Directive 90/385/EEC, in Directive 93/42/EEC and in Directive 98/79/EC, notified bodies should verify, where relevant, the fulfilment of the essential safety and health requirements contained in Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC [4], of the requirements contained in Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin [5] and of the common technical specifications for in vitro diagnostic medical devices laid down in Commission Decision 2002/364/EC of 7 May 2002 on common technical specifications for in vitro diagnostic medical devices [6].
Za zadostitev zakonskim zahtevam, določenim v Direktivi 90/385/EGS, Direktivi 93/42/EGS in Direktivi 98/79/ES, bi morali priglašeni organi, kjer je ustrezno, preverjati izpolnjevanje bistvenih varnostnih in zdravstvenih zahtev iz Direktive 2006/42/ES Evropskega parlamenta in Sveta z dne 17. maja 2006 o strojih in spremembah Direktive 95/16/ES [4], zahtev iz Uredbe Komisije (EU) št. 722/2012 z dne 8. avgusta 2012 o posebnih zahtevah v zvezi z zahtevami iz direktiv Sveta 90/385/EGS in 93/42/EGS glede aktivnih medicinskih pripomočkov za vsaditev in medicinskih pripomočkov, izdelanih z uporabo tkiv živalskega izvora [5], ter skupnih tehničnih specifikacij za in vitro diagnostične medicinske pripomočke iz Odločbe Komisije 2002/364/ES z dne 7. maja 2002 o skupnih tehničnih specifikacijah za in vitro diagnostične medicinske pripomočke [6].
In order to avoid omissions and mistakes in the verification by the notified bodies of the important aspects of clinical evaluation or, in the case of in vitro diagnostic medical devices, of performance evaluation, and with regard to the post-market clinical follow-up, or, in the case of in vitro diagnostic medical devices, to post-market follow up, it is important to provide specific advice with regard to the control of those requirements.
Za preprečevanje opustitev in napak priglašenih organov, ko preverjajo pomembne vidike kliničnega vrednotenja ali, v primeru in vitro diagnostičnih medicinskih pripomočkov, vrednotenja delovanja, in v zvezi s poprodajnim kliničnim spremljanjem ali, v primeru in vitro diagnostičnih medicinskih pripomočkov, poprodajnim spremljanjem je pomembno zagotoviti posebne nasvete glede nadzora nad temi zahtevami.
To facilitate the verification by the notified bodies of the technical documentation, the manufacturer’s device identification system and the declaration of conformity, it is important to provide specific advice with regard to the control of those requirements.
Da bi priglašeni organi lažje preverili tehnično dokumentacijo, proizvajalčev sistem identifikacije pripomočkov in izjavo o skladnosti, je pomembno zagotoviti posebne nasvete glede nadzora nad temi zahtevami.
Directive 90/385/EEC, Directive 93/42/EEC and Directive 98/79/EC do not provide any exceptions for outsourced production compared to in-house production.
Direktiva 90/385/EGS, Direktiva 93/42/EGS in Direktiva 98/79/ES ne določajo izjem za proizvodnjo, oddano v zunanje izvajanje, v primerjavi z notranjo proizvodnjo.
Accordingly, it is necessary to include in duly substantiated cases the most important subcontractors and suppliers in the conformity assessment procedures.
Skladno s tem je treba v ustrezno utemeljenih primerih najpomembnejše podizvajalce in dobavitelje vključiti v postopke ocenjevanja skladnosti.
Subcontractors or suppliers cannot fulfil in the manufacturers’ place crucial obligations of manufacturers, such as keeping available the full technical documentation, as this would void the concept of the manufacturer as responsible in accordance with Directive 90/385/EEC, Directive 93/42/EEC and Directive 98/79/EC.
Podizvajalci ali dobavitelji ne smejo izpolnjevati ključnih obveznosti proizvajalcev, kot je zagotavljanje razpoložljivosti celotne tehnične dokumentacije, namesto njih, saj bi to izničilo koncept odgovornosti proizvajalca v skladu z Direktivo 90/385/EGS, Direktivo 93/42/EGS in Direktivo 98/79/ES.
Therefore, the notified bodies should be advised on what they need to verify in case of outsourcing.
Zato bi bilo treba priglašenim organom svetovati, kaj morajo preveriti v primeru zunanjega izvajanja.
Though regarded as two independent exercises, it is necessary to strengthen the link between the quality system review and the review of the technical documentation on a sampling basis.
Čeprav se pregled sistemov kakovosti in pregled tehnične dokumentacije na podlagi vzorčenja štejeta za ločeni nalogi, je treba okrepiti povezavo med njima.
In the absence of established practice for unannounced audits it is important to determine the practicalities for such audits, as well as to provide advice on the arrangements needed for facilitating these audits,
Ob neobstoju ustaljene prakse za nenapovedane revizije je pomembno določiti praktične vidike za take revizije in zagotoviti nasvete o dogovorih, potrebnih za poenostavitev teh revizij –
To facilitate the consistent application of the conformity assessment provisions contained in Directive 90/385/EEC, Directive 93/42/EEC and Directive 98/79/EC, the notified bodies should apply the provisions of this Recommendation when they perform product assessments, quality system assessments and unannounced audits.
Za poenostavitev dosledne uporabe določb o ocenjevanju skladnosti, ki jih vsebujejo Direktiva 90/385/EGS, Direktiva 93/42/EGS in Direktiva 98/79/ES, bi morali priglašeni organi pri opravljanju ocen izdelkov, ocen sistemov kakovosti in nenapovedanih revizij uporabljati določbe tega priporočila.
By providing general guidelines for such assessments and unannounced audits, this Recommendation should facilitate the work of the notified bodies as well as the Member States’ evaluation thereof.
To priporočilo bi moralo z zagotavljanjem splošnih smernic za take ocene in nenapovedane revizije olajšati delo priglašenih organov in ocenjevanje tega dela, ki ga izvajajo države članice.
This Recommendation does not create any new rights and obligations.
S tem priporočilom se ne uvajajo nove pravice in obveznosti.
The legal requirements applicable to all types of devices and conformity assessments are set out in the Union legislation on medical devices.
Zakonske zahteve, ki veljajo za vse vrste pripomočkov in ocene skladnosti, so določene v zakonodaji Unije o medicinskih pripomočkih.
GENERAL GUIDELINES FOR AUDITS AND ASSESSMENTS
SPLOŠNE SMERNICE ZA REVIZIJE IN OCENE
The notified bodies should apply the following:
Priglašeni organi bi morali upoštevati naslednje:
Where the manufacturer has applied for a design dossier examination or for a type examination (hereinafter jointly referred to as ‘product assessment’), notified bodies should verify the conformity of the device under all product related aspects referred to in Directive 90/385/EEC, Directive 93/42/EEC and Directive 98/79/EC for detecting any non-compliance of the device and should apply Annex I.
kadar proizvajalec predloži vlogo za pregled projektnega spisa ali tipski pregled (v nadaljnjem besedilu skupaj: ocena izdelka), bi morali priglašeni organi preveriti skladnost pripomočka z vseh zadevnih vidikov iz Direktive 90/385/EGS, Direktive 93/42/EGS in Direktive 98/79/ES za odkrivanje morebitnih neskladnosti pripomočka ter bi morali uporabiti Prilogo I;
Where the manufacturer has applied for an assessment of its quality system, notified bodies should verify the conformity of the quality system with the quality-system related requirements contained in Directive 90/385/EEC, Directive 93/42/EEC and Directive 98/79/EC for detecting non-compliances of the quality system and should apply Annex II.
kadar proizvajalec predloži vlogo za oceno svojega sistema kakovosti, bi morali priglašeni organi preveriti skladnost sistema kakovosti z zadevnimi zahtevami za sisteme kakovosti iz Direktive 90/385/EGS, Direktive 93/42/EGS in Direktive 98/79/ES za odkrivanje neskladnosti sistema kakovosti ter bi morali uporabiti Prilogo II;
To verify the day-to-day compliance with legal obligations, notified bodies should, in addition to the initial, surveillance or renewal audits, visit the manufacturer or, if this is likely to ensure more efficient control, one of its subcontractors in charge of processes which are essential for ensuring compliance with legal requirements (‘critical subcontractor’) or a supplier of crucial components or of the entire devices (both: ‘crucial supplier’) without prior notice (‘unannounced audits’) in accordance with Annex III.
za preverjanje vsakdanje skladnosti z zakonskimi obveznostmi bi morali priglašeni organi poleg opravljanja začetnih revizij, nadzornih revizij ali revizij za podaljšanje obiskovati proizvajalca ali – če je verjetno, da bo zaradi tega nadzor učinkovitejši – enega izmed njegovih podizvajalcev, odgovornih za postopke, ki so bistveni za zagotavljanje skladnosti z zakonskimi zahtevami (v nadaljnjem besedilu: ključni podizvajalec), ali dobavitelja ključnih sestavnih delov ali celotnih pripomočkov (v nadaljnjem besedilu skupaj: ključni dobavitelj) brez predhodnega obvestila (v nadaljnjem besedilu: nenapovedane revizije) v skladu s Prilogo III.
Member States should draw this Recommendation to the attention of the notified bodies in the field of medical devices and should supervise the practice of notified bodies with respect to this Recommendation.
Države članice bi morale priglašene organe na področju medicinskih pripomočkov opozoriti na to priporočilo in nadzirati njihovo ravnanje v zvezi s tem priporočilom.
They should evaluate the notified bodies’ readiness to apply this Recommendation and in particular to perform unannounced audits when deciding on designations of bodies and on renewal or withdrawal of designations.
Pri odločanju o imenovanjih priglašenih organov ter o podaljšanju ali preklicu imenovanj bi morale države članice ocenjevati pripravljenost priglašenih organov za izvajanje tega priporočila in zlasti za opravljanje nenapovedanih revizij.
Done at Brussels, 24 September 2013.
V Bruslju, 24. septembra 2013
Product assessment
Ocena izdelka
Notified bodies should verify if the device is correctly qualified as a medical device and, in particular, whether the manufacturer has assigned a medical purpose to the device.
Priglašeni organi bi morali preveriti, ali je pripomoček pravilno opredeljen kot medicinski pripomoček in zlasti, ali mu je proizvajalec določil medicinski namen.
They should furthermore verify the classification of the device and whether the manufacturer has fulfilled the applicable conformity assessment obligations.
Preveriti bi morali še razvrstitev pripomočka in ali je proizvajalec izpolnil veljavne obveznosti glede ocenjevanja skladnosti.
They should satisfy the obligations of consultation for certain devices that incorporate a substance which, in case used separately, may be considered to be a medicinal product, a human blood derivative or an animal tissue [1].
Izpolniti bi morali tudi obveznosti glede posvetovanja za nekatere pripomočke, ki vključujejo snov, ki se lahko, če se uporablja ločeno, šteje za zdravilo, derivat človeške krvi ali živalsko tkivo [1].
Notified bodies should verify the compliance of the device with the relevant Essential Requirements set out in Annex 1 to Directive 90/385/EEC, Annex I to Directive 93/42/EEC and Annex I to Directive 98/79/EC and, if applicable, with the essential safety and health requirements (ESHR) set out in Directive 2006/42/EC.
Priglašeni organi bi morali preveriti skladnost pripomočka z ustreznimi bistvenimi zahtevami, opredeljenimi v Prilogi 1 k Direktivi 90/385/EGS, Prilogi I k Direktivi 93/42/EGS in Prilogi I k Direktivi 98/79/ES, ter, če je ustrezno, z bistvenimi varnostnimi in zdravstvenimi zahtevami, opredeljenimi v Direktivi 2006/42/ES.
In the case of in vitro diagnostic medical devices, where applicable, they should also verify the compliance of the device with the common technical specifications laid down in Decision 2002/364/EC or, when duly justified, with other technical solutions of a level at least equivalent.
Za in vitro diagnostične medicinske pripomočke bi morali po potrebi preveriti še skladnost pripomočka s skupnimi tehničnimi specifikacijami iz Odločbe Komisije 2002/364/ES oziroma, kadar je to ustrezno utemeljeno, z drugimi tehničnimi rešitvami vsaj enakovredne ravni.
Where doubts arise, in the framework of a design dossier examination, as to the conformity of a device, notified bodies should carry out or ask for relevant tests of the device.
Če se pojavijo dvomi, bi morali priglašeni organi v okviru pregleda projektnega spisa za zagotovitev skladnosti pripomočka opraviti ustrezne preizkuse pripomočka oziroma zaprositi zanje.
Notified bodies should examine the requirements regarding design and construction and the ESHR prior to examining the general requirements set out in Part I of Annex 1 to Directive 90/385/EEC, in Part A of Annex I to Directive 93/42/EEC and in Part A of Annex I to Directive 98/79/EC.
Priglašeni organi bi morali pred pregledovanjem izpolnjevanja splošnih zahtev iz dela I Priloge 1 k Direktivi 90/385/EGS, dela I Priloge I k Direktivi 93/42/EGS in dela A Priloge I k Direktivi 98/79/ES pregledati izpolnjevanje zahtev glede načrtovanja in izdelave ter bistvenih varnostnih in zdravstvenih zahtev.
They should apply special care to examine all the following aspects of the essential requirements:
Posebno skrb bi morali nameniti pregledovanju izpolnjevanja vseh naslednjih vidikov bistvenih zahtev:
design, manufacture and packaging;
načrtovanje, izdelava in pakiranje;
labelling on the device, on the packaging for each unit or on the sales packaging and instructions for use.
označevanje na pripomočku, na embalaži vsake enote oziroma na prodajni embalaži in navodila za uporabo.
The examination of the general requirements should ascertain that among others the following requirements have been met:
S pregledovanjem izpolnjevanja splošnih zahtev bi bilo treba zagotoviti, da so med drugim izpolnjene naslednje zahteve:
all hazards have been identified;
vse nevarnosti so bile prepoznane;
all risks associated with these hazards have been evaluated and have become part of the overall risk-benefit evaluation;
vsa tveganja, povezana s temi nevarnostmi, so bila ocenjena ter vključena v skupno oceno razmerja med tveganji in koristmi;
all these risks have been reduced as far as possible;
vsa ta tveganja so bila zmanjšana, kolikor je mogoče;
all remaining risks have been subject to protection measures;
za vsa preostala tveganja se uporabljajo zaščitni ukrepi;
safety principles have been applied in a way that is compatible with the state-of-the art.
varnostna načela se uporabljajo na način, ki je združljiv s stanjem tehničnega razvoja.
They should assess the need for and the appropriateness of a post-market clinical follow-up plan [2].
Oceniti bi morali potrebo po poprodajnem načrtu kliničnega spremljanja in njegovo ustreznost [2].
If no clinical investigation has been undertaken, they should verify that the device type in question and all the different types of risks linked to the device design, its materials, and its use are appropriately assessed by means of scientific literature or other existing clinical data so that no clinical investigation is needed; they should furthermore examine the special justification [3] needed for implantable devices and devices classified within class III according to Annex IX to Directive 93/42/EEC.
Če ni bila izvedena nobena klinična preiskava, bi morali preveriti, ali so zadevni tip pripomočka in vse različne vrste tveganj, povezane z načrtovanjem pripomočka ter njegovimi materiali in uporabo, ustrezno ocenjeni glede na znanstveno literaturo ali druge klinične podatke, tako da klinične preiskave niso potrebne; poleg tega bi morali pregledati tudi posebno utemeljitev [3], potrebno za pripomočke za vsaditev in pripomočke, razvrščene v razred III v skladu s Prilogo IX k Direktivi 93/42/EGS.
In the case of in vitro diagnostic medical devices, notified bodies should review the performance evaluation undertaken by the manufacturer and post-market follow up undertaken or planned by the manufacturer.
Za in vitro diagnostične medicinske pripomočke bi morali priglašeni organi pregledati vrednotenje delovanja, ki ga izvaja proizvajalec, in poprodajno spremljanje, ki ga izvaja ali načrtuje.
Notified bodies should verify all documentation related to the device’s conformity assessment.
Priglašeni organi bi morali preveriti vso dokumentacijo v zvezi z oceno skladnosti pripomočka.
To that end, they should verify that the technical documentation is correct, consistent, relevant, up-to-date and complete [4] and that it covers all variants and trade names of the device.
V ta namen bi morali preveriti, ali je tehnična dokumentacija pravilna, dosledna, ustrezna, ažurna in popolna [4] ter ali vključuje vse različice in tržna imena pripomočka.
They should furthermore verify that the manufacturer’s device identification system and its practice of defining which devices belong to the same type ensure that the notified body’s certificates, the manufacturer’s declarations of conformity and the manufacturer’s technical documentations can unequivocally be attributed to the device examined.
Poleg tega bi morali preveriti, ali proizvajalčev sistem identifikacije pripomočkov in njegova praksa opredeljevanja, kateri pripomočki pripadajo istemu tipu, zagotavljata, da je mogoče certifikate priglašenega organa ter proizvajalčeve izjave o skladnosti in tehnične dokumentacije nedvoumno pripisati pregledovanemu pripomočku.
They should finally verify that the draft declaration of conformity contains all the necessary items.
Nazadnje bi morali preveriti še, ali osnutek izjave o skladnosti vsebuje vse potrebne postavke.
The notified body should clearly document the conclusions of its assessment and it should be clearly evidenced how the conclusions are taken into account as part of the notified body’s decision making process.
Priglašeni organ bi moral jasno zabeležiti sklepe svoje ocene, obenem pa bi moralo biti jasno zabeleženo tudi, kako se sklepi upoštevajo kot del postopka odločanja priglašenega organa.