natgillin/translations-raw huggingface dataset:
to verify the performance claimed by the manufacturer and the compliance of class D devices with the applicable CS, when available, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent, as provided for in the third subparagraph of Article 48(3);
vzpostavitev in upravljanje mreže nacionalnih referenčnih laboratorijev po posvetovanju z nacionalnimi organi in objava seznama sodelujočih nacionalnih referenčnih laboratorijev ter njihovih posameznih nalog;
to carry out appropriate tests on samples of manufactured class D devices or batches of class D devices, as provided for in the Section 4.12 of Annex IX and in Section 5.1 of Annex XI;
sodelovanje pri razvoju ustreznih testnih in analitskih metod, ki se uporabljajo za postopke ugotavljanja skladnosti in nadzora trga;
to provide scientific and technical assistance to the Commission, the MDCG, the Member States and notified bodies in relation to the implementation of this Regulation;
sodelovanje s priglašenimi organi pri razvoju najboljših praks za izvajanje postopkov ugotavljanja skladnosti;
to provide scientific advice regarding the state of the art in relation to specific devices, or a category or group of devices;
priprava priporočil o primernem referenčnem materialu in referenčnih meritvenih postopkih višjega meroslovnega reda;
to set up and manage a network of national reference laboratories after consulting with the national authorities and publish a list of the participating national reference laboratories and their respective tasks;
sodelovanje pri oblikovanju skupnih specifikacij in mednarodnih standardov;
to contribute to the development of appropriate testing and analysis methods to be applied for conformity assessment procedures and market surveillance;
priprava znanstvenih mnenj v odziv na posvetovanja s priglašenimi organi v skladu s to uredbo in njihova elektronska objava ob upoštevanju nacionalnih določb o zaupnosti.
to collaborate with notified bodies in the development of best practices for the performance of conformity assessment procedures;
Komisija lahko na zahtevo države članice tudi imenuje referenčne laboratorije EU za primer, ko bi zadevna država članica želela uporabiti takšne laboratorije, da zagotovi preveritev učinkovitosti, ki jo navaja proizvajalec, in skladnosti pripomočkov razreda C z veljavnimi skupnimi specifikacijami, kadar so na voljo, ali z drugimi rešitvami, ki jih izbere proizvajalec, da zagotovi vsaj enakovredno raven varnosti in učinkovitosti.
to provide recommendations on suitable reference materials and reference measurement procedures of higher metrological order;
Referenčni laboratoriji EU izpolnjujejo naslednja merila:
to contribute to the development of CS and of international standards;
imajo dovolj osebja, ki je ustrezno usposobljeno in ima zadostno znanje in izkušnje na področju in vitro diagnostičnih medicinskih pripomočkov, za katere so bili imenovani;
to provide scientific opinions in response to consultations by notified bodies in accordance with this Regulation and publish them by electronic means having considered national provisions on confidentiality.
imajo potrebno opremo in referenčni material za izvajanje nalog, ki so jim bile dodeljene;
At the request of a Member State, the Commission may also designate the EU reference laboratories where that Member State wishes to have recourse to such laboratories to ensure the verification of the performance claimed by the manufacturer and the compliance of class C devices with the applicable CS when available, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent.
imajo potrebno znanje o mednarodnih standardih in najboljših praksah;
The EU reference laboratories shall satisfy the following criteria:
imajo ustrezno upravno ureditev in strukturo;
have adequate and appropriately qualified staff with adequate knowledge and experience in the field of the in vitro diagnostic medical devices for which they are designated;
zagotavljajo, da njihovo osebje spoštuje zaupnost informacij in podatkov, pridobljenih pri izvajanju svojih nalog.
possess the necessary equipment and reference material to carry out the tasks assigned to them;
delujejo v javnem interesu in neodvisno;
have the necessary knowledge of international standards and best practices;
zagotovijo, da njihovo osebje nima finančnih ali drugih interesov v industriji in vitro diagnostičnih medicinskih pripomočkov, ki bi lahko vplivali na njihovo nepristranskost, prijavi kakršne koli neposredne in posredne interese v industriji in vitro diagnostičnih medicinskih pripomočkov ter da v primeru sprememb te informacije vedno posodobi.
have an appropriate administrative organisation and structure;
Referenčni laboratoriji EU oblikujejo mrežo, da bi lahko usklajevali in harmonizirali svoje delovne metode glede testiranja in ocenjevanja.
ensure that their staff observe the confidentiality of information and data obtained in carrying out their tasks;
To usklajevanje in harmonizacija vključuje:
act in the public interest and in an independent manner;
uporabo usklajenih metod, postopkov in procesov;
ensure that their staff do not have financial or other interests in the in vitro diagnostic medical device industry which could affect their impartiality, declare any other direct and indirect interests they may have in the in vitro diagnostic medical device industry and update this declaration whenever a relevant change occurs.
dogovore glede uporabe enakih referenčnih materialov ter skupnih testnih in serokonverzijskih vzorcev;
The EU reference laboratories shall form a network in order to coordinate and harmonise their working methods as regards testing and assessment.
uvedbo skupnih meril glede ocenjevanja in razlage;
That coordination and harmonisation shall involve:
uporabo skupnih protokolov testiranja in ocenjevanje rezultatov testov z uporabo standardiziranih in usklajenih metod vrednotenja;
applying coordinated methods, procedures and processes;
uporabo standardiziranih in usklajenih poročil o testih;
agreeing on the use of same reference materials and common test samples and seroconversion panels;
razvoj, uporabo in vzdrževanje sistema za medsebojno strokovno pregledovanje;
establishing common assessment and interpretation criteria;
organizacijo rednih testov za ocenjevanje kakovosti (vključno z medsebojnimi pregledi kakovosti in primerljivosti rezultatov testov);
using common testing protocols and assessing the test results using standardised and coordinated evaluation methods;
dogovore o skupnih smernicah, navodilih, postopkovnih navodilih ali standardnih operativnih postopkih;
using standardised and coordinated test reports;
usklajevanje uvajanja metod testiranja za nove tehnologije in v skladu z novimi ali spremenjenimi skupnimi specifikacijami;
developing, applying and maintaining a peer review system;
ponovno oceno zadnjega stanja tehničnega razvoja na podlagi primerjalnih rezultatov testov ali z naknadnimi študijami na zahtevo države članice ali Komisije.
organizing regular quality assessment tests (including mutual checks on the quality and comparability of test results);
Referenčnim laboratorijem EU se lahko dodeli finančni prispevek Unije.
agreeing on joint guidelines, instructions, procedural instructions or standard operational procedures;
Komisija lahko z izvedbenimi akti sprejme podrobne ureditve in znesek finančnega prispevka Unije za referenčne laboratorije EU, pri tem pa upošteva cilje, kot so varovanje zdravja in varnosti, podpiranje inovacij in stroškovna učinkovitost.
coordinating the introduction of testing methods for new technologies and according to new or amended CS;
Kadar priglašeni organi ali države članice zahtevajo znanstveno ali tehnično pomoč ali znanstveno mnenje referenčnega laboratorija EU, se od njih lahko zahteva, da na podlagi vnaprej določenih in preglednih pogojev plačajo pristojbine za celotno ali delno kritje stroškov, nastalih v navedenem laboratoriju zaradi izvedbe zahtevane naloge.
reassessing the state of the art on the basis of comparative test results or by further studies, as requested by a Member State or by the Commission.
Komisija z izvedbenimi akti določi:
The EU reference laboratories may be granted a Union financial contribution.
podrobna pravila za lažjo uporabo odstavka 2 tega člena in podrobna pravila za zagotavljanje izpolnjevanja meril iz odstavka 4 tega člena;
The Commission may adopt, by means of implementing acts, the detailed arrangements and the amount of a Union financial contribution to the EU reference laboratories, taking into account the objectives of health and safety protection, support of innovation and cost-effectiveness.
strukturo in višino pristojbin iz odstavka 7 tega člena, ki jih lahko zaračunava referenčni laboratorij EU za pripravo znanstvenih mnenj kot odziv na posvetovanja s priglašenimi organi in državami članicami v skladu s to uredbo, ob upoštevanju ciljev, kot so varovanje zdravja in varnosti ljudi, podpiranje inovacij in stroškovna učinkovitost.
Where notified bodies or Member States request scientific or technical assistance or a scientific opinion from an EU reference laboratory, they may be required to pay fees to wholly or partially cover the costs incurred by that laboratory in carrying out the requested task according to predetermined and transparent terms and conditions.
Referenčni laboratoriji EU so nadzorovani, kar vključuje obiske na kraju samem in presoje, s strani Komisije za preverjanje skladnosti z zahtevami iz te uredbe.
The Commission shall specify by means of implementing acts:
Če se pri nadzoru ugotovi, da referenčni laboratorij EU ne izpolnjuje zahtev, na podlagi katerih je bil imenovan, Komisija z izvedbenimi akti sprejme ustrezne ukrepe, vključno z omejitvijo, začasnim ali trajnim preklicem imenovanja.
detailed rules to facilitate the application of paragraph 2 of this Article and detailed rules to ensure compliance with the criteria referred to in paragraph 4 of this Article.
Določbe člena 107(1) Uredbe (EU) 2017/745 se uporabljajo za osebje referenčnih laboratorijev EU.
the structure and the level of the fees referred to in paragraph 7 of this Article which may be levied by an EU reference laboratory for providing scientific opinions in response to consultations by notified bodies and Member States in accordance with this Regulation, taking into account the objectives of human health and safety protection, support of innovation and cost-effectiveness.
Člen 101
The EU reference laboratories shall be subject to controls, including on-site visits and audits, by the Commission to verify compliance with the requirements of this Regulation.
Registri pripomočkov in banke podatkov
If those controls find that an EU reference laboratory is not complying with the requirements for which it has been designated, the Commission, by means of implementing acts, shall take appropriate measures, including the restriction, suspension or withdrawal of the designation.
Komisija in države članice sprejmejo vse ustrezne ukrepe za spodbujanje vzpostavitve registrov in bank podatkov za posebne vrste pripomočkov, v katerih so določena skupna načela za zbiranje primerljivih informacij.
The provisions in Article 107(1) of Regulation (EU) 2017/745 shall apply to the staff of the EU reference laboratories.
Takšni registri in banke podatkov prispevajo k neodvisni oceni dolgoročne varnosti in učinkovitosti pripomočkov.
Article 101
POGLAVJE IX
Device registers and databanks
ZAUPNOST, VARSTVO PODATKOV, FINANCIRANJE IN KAZNI
The Commission and the Member States shall take all appropriate measures to encourage the establishment of registers and databanks for specific types of devices setting common principles to collect comparable information.
Člen 102
Such registers and databanks shall contribute to the independent evaluation of the long-term safety and performance of devices.
Zaupnost
CHAPTER IX
Razen če v tej uredbi ni drugače določeno in brez poseganja v obstoječe nacionalne določbe in prakse držav članic o zaupnosti, vse strani, vključene v uporabo te uredbe, spoštujejo zaupnost informacij in podatkov, pridobljenih pri izvajanju svojih nalog, da se zaščitijo:
CONFIDENTIALITY, DATA PROTECTION, FUNDING AND PENALTIES
osebni podatki v skladu s členom 103;
Article 102
zaupne poslovne informacije in poslovne skrivnosti fizičnih ali pravnih oseb, vključno s pravicami intelektualne lastnine, razen če je razkritje v javnem interesu;
Confidentiality
učinkovito izvajanje te uredbe, zlasti za namene inšpekcijskih pregledov, raziskav ali presoj.
Unless otherwise provided for in this Regulation and without prejudice to existing national provisions and practices in the Member States on confidentiality, all parties involved in the application of this Regulation shall respect the confidentiality of information and data obtained in carrying out their tasks in order to protect the following:
Brez poseganja v odstavek 1 se informacije, ki jih zaupno izmenjajo pristojni organi ter pristojni organi in Komisija, ne razkrijejo brez predhodnega dogovora z organom, ki jih je sporočil.
personal data in accordance with Article 103;
Odstavka 1 in 2 ne vplivata niti na pravice in obveznosti Komisije, držav članic in priglašenih organov v zvezi z izmenjavo informacij in razširjenjem opozoril niti na obveznost zadevnih oseb, da zagotovijo podatke v skladu s kazenskim pravom.
commercially confidential information and trade secrets of a natural or legal person, including intellectual property rights unless disclosure is in the public interest;
Komisija in države članice lahko izmenjajo zaupne informacije z regulativnimi organi tretjih držav, s katerimi so sklenile dvostranske ali večstranske dogovore o zaupnosti.
the effective implementation of this Regulation, in particular for the purpose of inspections, investigations or audits.
Člen 103
Without prejudice to paragraph 1, information exchanged on a confidential basis between competent authorities and between competent authorities and the Commission shall not be disclosed without the prior agreement of the originating authority.
Varstvo podatkov
Paragraphs 1 and 2 shall not affect the rights and obligations of the Commission, Member States and notified bodies with regard to exchange of information and the dissemination of warnings, nor the obligations of the persons concerned to provide information under criminal law.
Države članice pri obdelavi osebnih podatkov v državah članicah v skladu s to uredbo uporabljajo Direktivo 95/46/ES.
The Commission and Member States may exchange confidential information with regulatory authorities of third countries with which they have concluded bilateral or multilateral confidentiality arrangements.
Komisija pri obdelavi osebnih podatkov v skladu s to uredbo uporablja Uredbo (ES) št. 45/2001.
Data protection
Zaračunavanje pristojbin
Member States shall apply Directive 95/46/EC to the processing of personal data carried out in the Member States pursuant to this Regulation.
Ta uredba ne posega v možnost držav članic, da zaračunavajo pristojbine za dejavnosti, določene v tej uredbi, če se višina pristojbin določi na pregleden način in na podlagi načela povračila stroškov.
Regulation (EC) No 45/2001 shall apply to the processing of personal data carried out by the Commission pursuant to this Regulation.
Države članice o tem obvestijo Komisijo in druge države članice najmanj tri mesece pred predvidenim sprejetjem strukture in višine pristojbin.
Article 104
Struktura in višina pristojbin sta na zahtevo javno dostopni.
Levying of fees
Člen 105
This Regulation shall be without prejudice to the possibility for Member States to levy fees for the activities set out in this Regulation, provided that the level of the fees is set in a transparent manner and on the basis of cost-recovery principles.
Financiranje dejavnosti v zvezi z imenovanjem in spremljanjem priglašenih organov
Member States shall inform the Commission and the other Member States at least three months before the structure and level of fees is to be adopted.
Stroške, povezane s skupnimi dejavnostmi ocenjevanja, krije Komisija.
The structure and level of fees shall be made publicly available on request.
Komisija z izvedbenimi akti določi obseg in strukturo stroškov, ki se lahko povrnejo, ter druga potrebna izvedbena pravila.
Funding of activities related to designation and monitoring of notified bodies
Kazni
The costs associated with joint assessment activities shall be covered by the Commission.
Države članice določijo pravila o kaznih, ki se uporabljajo za kršitve določb te uredbe in sprejmejo vse potrebne ukrepe za zagotovitev, da se te kazni izvajajo.
The Commission shall, by means of implementing acts, lay down the scale and structure of recoverable costs and other necessary implementing rules.
Te kazni morajo biti učinkovite, sorazmerne in odvračilne.
Article 106
Države članice o teh pravilih in ukrepih uradno obvestijo Komisijo do 25. februarja 2022 in jo brez odlašanja uradno obvestijo o vsakršni naknadni spremembi, ki nanje vpliva.
Penalties
POGLAVJE X
The Member States shall lay down the rules on penalties applicable for infringement of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented.
KONČNE DOLOČBE
The penalties provided for shall be effective, proportionate, and dissuasive.
Člen 107
The Member States shall notify the Commission of those rules and of those measures by 25 February 2022 and shall notify it without delay of any subsequent amendment affecting them.
Postopek v odboru
CHAPTER X
Komisiji pomaga Odbor za medicinske pripomočke, ustanovljen s členom 114 Uredbe (EU) 2017/745.
FINAL PROVISIONS
Ta odbor je odbor v smislu Uredbe (EU) št. 182/2011.
Article 107
Pri sklicevanju na ta odstavek se uporablja člen 4 Uredbe (EU) št. 182/2011.
The Commission shall be assisted by the Committee on Medical Devices established by Article 114 of Regulation (EU) 2017/745.
Kadar odbor ne poda mnenja, Komisija osnutka izvedbenega akta ne sprejme in uporabi se tretji pododstavek člena 5(4) Uredbe (EU) št. 182/2011.
That committee shall be a committee within the meaning of Regulation (EU) No 182/2011
Pri sklicevanju na ta odstavek se uporablja člen 8 Uredbe (EU) št. 182/2011 v povezavi s členom 4 ali 5 navedene uredbe, kakor je primerno.
Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.
Člen 108
Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
Izvajanje prenosa pooblastila
Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply.
Pooblastilo za sprejemanje delegiranih aktov je preneseno na Komisijo pod pogoji, določenimi v tem členu.
Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 4 or 5 thereof, as appropriate, shall apply.
Prenos pooblastila se samodejno podaljšuje za enako dolga obdobja, razen če Evropski parlament ali Svet nasprotuje temu podaljšanju najpozneje tri mesece pred koncem vsakega obdobja.
The power to adopt delegated acts referred to in Articles 10(4), 17(4), 24(10), 51(6) and 66(8) shall be conferred on the Commission for a period of five years from 25 May 2017.
Sklep ne vpliva na veljavnost že veljavnih delegiranih aktov.
The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period.
Komisija se pred sprejetjem delegiranega akta posvetuje s strokovnjaki, ki jih imenujejo države članice, v skladu z načeli, določenimi v Medinstitucionalnem sporazumu z dne 13. aprila 2016 o boljši pripravi zakonodaje.
The delegation of power referred to in Articles 10(4), 17(4), 24(10), 51(6) and 66(8) may be revoked at any time by the European Parliament or by the Council.
Delegirani akt, sprejet na podlagi členov 10(4), 17(4), 24(10), 51(6) in 66(8), začne veljati le, če mu niti Evropski parlament niti Svet ne nasprotuje v roku treh mesecev od uradnega obvestila Evropskemu parlamentu in Svetu o tem aktu ali če pred iztekom tega roka tako Evropski parlament kot Svet obvestila Komisijo, da mu ne bosta nasprotovala.
It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein.
Člen 109
It shall not affect the validity of any delegated acts already in force.
Ločeni delegirani akti za različna prenesena pooblastila
Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.
Komisija sprejme ločen delegirani akt za vsako pooblastilo, preneseno nanjo na podlagi te uredbe.
As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
Člen 110
A delegated act adopted pursuant to Articles 10(4), 17(4), 24(10), 51(6) and 66(8) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of three months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object.
Prehodne določbe
That period shall be extended by three months at the initiative of the European Parliament or of the Council.
Od 26. maja 2022 vsaka objava uradnega obvestila v zvezi s priglašenim organom v skladu z Direktivo 98/79/ES postane neveljavna.
Article 109
Certifikati, ki jih v skladu z Direktivo 98/79/ES izdajo priglašeni organi pred 25. majem 2017, ostanejo veljavni do konca obdobja, navedenega na certifikatu, razen certifikatov, izdanih v skladu s Prilogo VI k Direktivi 98/79/ES, ki postanejo neveljavni najpozneje 27. maja 2024.
Separate delegated acts for different delegated powers
Certifikati, ki jih v skladu z Direktivo 98/79/ES izdajo priglašeni organi po 25. maju 2017, postanejo neveljavni do 27. maja 2024.
The Commission shall adopt a separate delegated act in respect of each power delegated to it pursuant to this Regulation.
Z odstopanjem od člena 5 te uredbe se pripomoček, ki ima certifikat, ki je bil izdan v skladu z Direktivo 98/79/ES in je veljaven na podlagi odstavka 2 tega člena, lahko da na trg ali v uporabo samo, če je od datuma začetka uporabe te uredbe še naprej skladen z navedeno direktivo in če se zasnova in predvideni namen nista bistveno spremenila.
Article 110
Vendar se zahteve te uredbe, ki zadevajo nadzor po dajanju na trg, nadzor trga, vigilanco, registracijo gospodarskih subjektov in pripomočkov, uporabljajo namesto ustreznih zahtev iz navedene direktive.
Transitional provisions
Brez poseganja v poglavje IV in odstavek 1 tega člena je priglašeni organ, ki je izdal certifikat iz prvega pododstavka, še naprej odgovoren za ustrezen nadzor v zvezi z vsemi veljavnimi zahtevami, ki zadevajo pripomočke, ki jih je certificiral.
From 26 May 2022, any publication of a notification in respect of a notified body in accordance with Directive 98/79/EC shall become void.
Pripomočki, zakonito dani na trg v skladu z Direktivo 98/79/ES pred 26. majem 2022 in pripomočki, ki so bili dani na trg po 26. maju 2022 na podlagi certifikata iz odstavka 2 tega člena, so lahko še naprej dostopni na trgu ali dani v uporabo do 27. maja 2025.
Certificates issued by notified bodies in accordance with Directive 98/79/EC prior to 25 May 2017 shall remain valid until the end of the period indicated on the certificate, except for certificates issued in accordance with Annex VI to Directive 98/79/EC which shall become void at the latest on 27 May 2024.
Z odstopanjem od Direktive 98/79/EC se lahko pripomočki, ki so skladni s to uredbo, dajo na trg pred 26. majem 2022.