natgillin/translations-raw huggingface dataset:
The penalties provided for shall be effective, proportionate, and dissuasive.
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 Member States shall notify the Commission of those rules and of those measures by 25 February 2020 and shall notify it, without delay, of any subsequent amendment affecting them.
Komisija takoj po sprejetju delegiranega akta o njem sočasno uradno obvesti Evropski parlament in Svet.
CHAPTER X
Delegirani akt, sprejet na podlagi členov 1(5), 3, 10(4), 18(3), 19(4), 27(10), 44(11), 52(5), 56(6), 61(8), 70(8) in 106(15), 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.
Article 114
Člen 116
Committee procedure
Ločeni delegirani akti za različna prenesena pooblastila
The Commission shall be assisted by a Committee on Medical Devices.
Komisija sprejme ločen delegirani akt za vsako pooblastilo, preneseno nanjo v skladu s to uredbo.
That Committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
Člen 117
Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.
Sprememba Direktive 2001/83/ES
Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
V Prilogi I k Direktivi 2001/83/ES se točka 12 oddelka 3.2. nadomesti z naslednjim:
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.
Če v skladu z drugim pododstavkom člena 1(8) ali drugim pododstavkom člena 1(9) Uredbe (EU) 2017/745 Evropskega parlamenta in Sveta izdelek ureja ta direktiva, dokumentacija za pridobitev dovoljenja za promet vsebuje, če so na voljo, rezultate ugotavljanja skladnosti tistega dela, ki šteje za pripomoček, z ustreznimi splošnimi zahtevami o varnosti in učinkovitosti iz Priloge I k navedeni uredbi, ki so navedeni v proizvajalčevi izjavi EU o skladnosti ali ustreznem certifikatu, ki ga je izdal priglašeni organ, o izdaji dovoljenja proizvajalcu, da namesti oznako CE na medicinski pripomoček.
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.
Če dokumentacija ne vsebuje rezultatov ocene skladnosti iz prvega pododstavka in kadar mora biti pri ugotavljanju skladnosti pripomočka, če se uporablja ločeno, v skladu z Uredbo (EU) 2017/745 vključen priglašeni organ, organ od vložnika zahteva, da predloži mnenje o skladnosti tistega dela, ki se šteje za pripomoček, z ustreznimi splošnimi zahtevami o varnosti in učinkovitosti iz Priloge I k navedeni uredbi, ki ga je izdal priglašeni organ, imenovan v skladu z navedeno uredbo za zadevno vrsto pripomočka.
Article 115
Člen 118
Exercise of the delegation
Sprememba Uredbe (ES) št. 178/2002
The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
V tretjem odstavku člena 2 Uredbe (ES) št. 178/2002 se doda naslednja točka:
The power to adopt delegated acts referred to in Articles 1(5), 3, 10(4), 18(3), 19(4), 27(10), 44(11), 52(5), 56(6), 61(8), 70(8) and 106(15) shall be conferred on the Commission for a period of five years from 25 May 2017.
medicinski pripomočki v smislu Uredbe (EU) 2017/745 Evropskega parlamenta in Sveta.
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.
Člen 119
The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Sprememba Uredbe (ES) št. 1223/2009
The delegation of power referred to in Articles 1(5), 3, 10(4), 18(3), 19(4), 27(10), 44(11), 52(5), 56(6), 61(8), 70(8) and 106(15) may be revoked at any time by the European Parliament or by the Council.
V členu 2 Uredbe (ES) št. 1223/2009 se doda naslednji odstavek:
A decision to revoke shall put an end to the delegation of the power specified in that decision.
Komisija lahko na zahtevo države članice ali na lastno pobudo sprejme potrebne ukrepe, da se ugotovi, ali določeni izdelek ali skupina izdelkov spada v opredelitev „kozmetični izdelek“.
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.
Navedeni ukrepi se sprejmejo v skladu z regulativnim postopkom iz člena 32(2).“
It shall not affect the validity of any delegated acts already in force.
Člen 120
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.
Prehodne določbe
As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
Od 26. maja 2020 vsaka objava uradnega obvestila v zvezi s priglašenim organom v skladu z direktivama 90/385/EGS in 93/42/EGS postane neveljavna.
A delegated act adopted pursuant to Articles 1(5), 3, 10(4), 18(3), 19(4), 27(10), 44(11), 52(5), 56(6), 61(8), 70(8) and 106(15) 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.
Certifikati, ki jih v skladu z direktivama 90/385/EGS in 93/42/EGS izdajo priglašeni organi pred 25. majem 2017, ostanejo veljavni do konca obdobja, navedenega na certifikatu, razen certifikatov, izdanih v skladu s Prilogo 4 k Direktivi 90/385/EGS ali Prilogo IV k Direktivi 93/42/EGS, ki postanejo neveljavni najpozneje 27. maja 2022.
That period shall be extended by three months at the initiative of the European Parliament or of the Council.
Certifikati, ki jih izdajo priglašeni organi v skladu z direktivama 90/385/EGS in 93/42/EGS od 25. maja 2017, ostanejo veljavni do konca obdobja, navedenega na certifikatu, ki ne presega pet let od datuma njegove izdaje.
Article 116
Vendar postanejo neveljavni najpozneje 27. maja 2024.
Separate delegated acts for different delegated powers
Z odstopanjem od člena 5 te uredbe se pripomoček, ki ima certifikat, ki je bil izdan v skladu z Direktivo 90/385/EGS ali Direktivo 93/42/EGS 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 s katero koli od navedenih direktiv in če se zasnova in predvideni namen nista bistveno spremenila.
The Commission shall adopt a separate delegated act in respect of each power delegated to it pursuant to this Regulation.
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 navedenih direktiv.
Article 117
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.
Amendment to Directive 2001/83/EC
Pripomočki, ki so bili zakonito dani na trg v skladu z direktivama 90/385/EGS in 93/42/EGS pred 26. majem 2020, in pripomočki, ki so bili dani na trg od 26. maja 2020 na podlagi certifikata iz odstavka 2 tega člena, so lahko še naprej dostopni na trgu ali dani v uporabo do 27. maja 2025.
In Annex I to Directive 2001/83/EC, point 12 of Section 3.2. is replaced by the following:
Z odstopanjem od direktiv 90/385/EGS in 93/42/EGS se lahko pripomočki, ki so skladni s to uredbo, dajo na trg pred 26. majem 2020.
Where, in accordance with the second subparagraph of Article 1(8) or the second subparagraph of Article 1(9) of Regulation (EU) 2017/745 of the European Parliament and of the Council, a product is governed by this Directive, the marketing authorisation dossier shall include, where available, the results of the assessment of the conformity of the device part with the relevant general safety and performance requirements set out in Annex I to that Regulation contained in the manufacturer's EU declaration of conformity or the relevant certificate issued by a notified body allowing the manufacturer to affix a CE marking to the medical device.
Kar zadeva pripomočke, za katere se uporablja postopek posvetovanja, določen v členu 54, se uporablja odstavek 5 tega člena, pod pogojem, da so bila opravljena obvezna imenovanja v Koordinacijsko skupino za medicinske pripomočke in strokovne odbore.
If the dossier does not include the results of the conformity assessment referred to in the first subparagraph and where for the conformity assessment of the device, if used separately, the involvement of a notified body is required in accordance with Regulation (EU) 2017/745, the authority shall require the applicant to provide an opinion on the conformity of the device part with the relevant general safety and performance requirements set out in Annex I to that Regulation issued by a notified body designated in accordance with that Regulation for the type of device in question.
Z odstopanjem od člena 10a in točke (a) člena 10b(1) Direktive 90/385/EGS ter člena 14(1) in (2) in točk (a) in (b) člena 14a(1) Direktive 93/42/EGS se za proizvajalce, pooblaščene predstavnike, uvoznike in priglašene organe, ki v obdobju, ki se začne na poznejši od obeh datumov iz točke (d) člena 123(3) in konča 18 mesecev pozneje, ki izpolnjujejo zahteve iz člena 29(4) in člena 56(5) te uredbe, šteje, da izpolnjujejo zahteve iz zakonov in drugih predpisov, ki so jih države članice sprejele v skladu s členom 10a Direktive 90/385/EGS oziroma členom 14(1) in (2) Direktive 93/42/EGS in s točko (a) člena 10b(1) Direktive 90/385/EGS oziroma točkama (a) in (b) člena 14a(1) Direktive 93/42/EGS, kakor je določeno v Sklepu 2010/227/EU.
Article 118
Dovoljenja, ki jih izdajo pristojni organi držav članic v skladu s členom 9(9) Direktive 90/385/EGS ali členom 11(13) Direktive 93/42/EGS, ostanejo veljavna do datuma, navedenega v dovoljenju.
Amendment to Regulation (EC) No 178/2002
Pripomočki, ki v skladu s točkama (f) in (g) člena 1(6) spadajo v področje uporabe te uredbe in so bili zakonito dani na trg ali v uporabo v skladu s pravili, ki veljajo v državah članicah pred 26. majem 2020, se lahko še naprej dajejo na trg in v uporabo v zadevnih državah članicah.
In the third paragraph of Article 2 of Regulation (EC) No 178/2002, the following point is added:
Klinične raziskave, ki so se začele izvajati v skladu s členom 10 Direktive 90/385/EGS ali členom 15 Direktive 93/42/EGS pred 26. majem 2020, se lahko še naprej izvajajo.
Article 119
Dokler Komisija v skladu s členom 27(2) ne imenuje subjektov izdajateljev, se GS1, HIBCC in ICCBBA štejejo za imenovane subjekte izdajatelje.
Amendment to Regulation (EC) No 1223/2009
Člen 121
In Article 2 of Regulation (EC) No 1223/2009, the following paragraph is added:
Ocena
The Commission may, at the request of a Member State or on its own initiative, adopt the necessary measures to determine whether or not a specific product or group of products falls within the definition ‘cosmetic product’.
Komisija do 27. maja 2027 oceni uporabo te uredbe in pripravi poročilo o oceni napredka pri doseganju ciljev te uredbe, vključno z oceno sredstev, potrebnih za izvajanje te uredbe.
Those measures shall be adopted in accordance with the regulatory procedure referred to in Article 32(2).’.
Posebna pozornost se nameni sledljivosti medicinskih pripomočkov prek UDI, ki jo v skladu s členom 27 hranijo gospodarski subjekti, zdravstvene ustanove in zdravstveni delavci.
Transitional provisions
Razveljavitev
From 26 May 2020, any publication of a notification in respect of a notified body in accordance with Directives 90/385/EEC and 93/42/EEC shall become void.
Brez poseganja v člen 120(3) in (4) te uredbe in brez poseganja v obveznosti držav članic in proizvajalcev v zvezi z vigilanco ter v obveznosti proizvajalcev v zvezi z omogočanjem dostopnosti dokumentacije na podlagi direktiv 90/385/EGS in 93/42/EGS, se ti dve direktivi razveljavita z učinkom od 26. majem 2020, razen:
Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC 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 4 to Directive 90/385/EEC or Annex IV to Directive 93/42/EEC which shall become void at the latest on 27 May 2022.
členov 8 in 10, točk (b) in (c) člena 10b(1), člena 10b(2) in člena 10b(3) Direktive 90/385/EGS in obveznosti v zvezi z vigilanco in kliničnimi raziskavami, ki so določene v ustreznih prilogah, ki se razveljavijo z učinkom od poznejšega od datumov iz točke (d) člena 123(3) te uredbe;
Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC from 25 May 2017 shall remain valid until the end of the period indicated on the certificate, which shall not exceed five years from its issuance.
člena 10a in točke (a) člena 10b(1) Direktive 90/385/EGS in obveznosti v zvezi z registracijo pripomočkov in gospodarskih subjektov ter priglasitvijo certifikatov, ki so določene v ustreznih prilogah, ki se razveljavita z učinkom 18 mesecev od poznejšega od datumov iz točke (d) člena 123(3) te uredbe;
They shall however become void at the latest on 27 May 2024.
člena 10, točk (c) in (d) člena 14a(1), člena 14a(2), člena 14a(3) in člena 15 Direktive 93/42/EGS in obveznosti v zvezi z vigilanco in kliničnimi raziskavami, ki so določene v ustreznih prilogah, ki se razveljavijo z učinkom od poznejšega od datumov iz točke (d) člena 123(3) te uredbe, ter
By way of derogation from Article 5 of this Regulation, a device with a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and which is valid by virtue of paragraph 2 of this Article may only be placed on the market or put into service provided that from the date of application of this Regulation it continues to comply with either of those Directives, and provided there are no significant changes in the design and intended purpose.
člena 14(1) in (2) ter točk (a) in (b) člena 14a(1) Direktive 93/42/EGS in obveznosti v zvezi z registracijo pripomočkov in gospodarskih subjektov ter priglasitvijo certifikatov, ki so določene v ustreznih prilogah, ki se razveljavijo z učinkom 18 mesecev od poznejšega od datumov iz točke (d) člena 123(3) te uredbe.
However, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives.
Kar zadeva pripomočke iz člena 120 (3) in (4) te uredbe, se direktivi iz prvega odstavka še naprej uporabljata do 27. maja 2025, in sicer kolikor je potrebno za uporabo navedenih odstavkov.
Without prejudice to Chapter IV and paragraph 1 of this Article, the notified body that issued the certificate referred to in the first subparagraph shall continue to be responsible for the appropriate surveillance in respect of all of the applicable requirements relating to the devices it has certified.
Ne glede na prvi odstavek ostaneta uredbi (EU) št. 207/2012 in (EU) št. 722/2012 veljavni in se še naprej uporabljata vse do morebitne razveljavitve z izvedbenimi akti, ki jih Komisija sprejme v skladu s to uredbo.
Devices lawfully placed on the market pursuant to Directives 90/385/EEC and 93/42/EEC prior to 26 May 2020, and devices placed on the market from 26 May 2020 by virtue of a certificate as referred to in paragraph 2 of this Article, may continue to be made available on the market or put into service until 27 May 2025.
Sklicevanja na razveljavljeni direktivi se razumejo kot sklicevanja na to uredbo in se berejo v skladu s korelacijsko tabelo iz Priloge XVII k tej uredbi.
By way of derogation from Directives 90/385/EEC and 93/42/EEC, devices which comply with this Regulation may be placed on the market prior to 26 May 2020.
Člen 123
By way of derogation from Directives 90/385/EEC and 93/42/EEC, conformity assessment bodies which comply with this Regulation may be designated and notified prior 26 May 2020.
Začetek veljavnosti in datum začetka uporabe
Notified bodies which are designated and notified in accordance with this Regulation may carry out the conformity assessment procedures laid down in this Regulation and issue certificates in accordance with this Regulation prior to 26 May 2020.
Ta uredba začne veljati dvajseti dan po objavi v Uradnem listu Evropske unije.
As regards devices subject to the consultation procedure laid down in Article 54, paragraph 5 of this Article shall apply provided that the necessary appointments to the MDCG and expert panels have been made.
Uporablja se od 26. maja 2020.
By way of derogation from Article 10a and point (a) of Article 10b(1) of Directive 90/385/EEC and Article 14(1) and (2) and points (a) and (b) of Article 14a(1) of Directive 93/42/EEC, manufacturers, authorised representatives, importers and notified bodies which, during the period starting on the later of the dates referred to point (d) of Article 123(3) and ending 18 months later, comply with Article 29(4) and Article 56(5) of this Regulation shall be considered to comply with the laws and regulations adopted by Member States in accordance with, respectively, Article 10a of Directive 90/385/EEC or Article 14(1) and (2) of Directive 93/42/EEC and with, respectively, point (a) of Article 10b(1) of Directive 90/385/EEC or points (a) and (b) of Article 14a(1) of Directive 93/42/EEC as specified in Decision 2010/227/EU.
Z odstopanjem od odstavka 2:
Authorisations granted by the competent authorities of the Member States in accordance with Article 9(9) of Directive 90/385/EEC or Article 11(13) of Directive 93/42/EEC shall keep the validity indicated in the authorisation.
se člena 101 in 103 uporabljata od 26. novembra 2017;
Devices falling within the scope of this Regulation in accordance with points (f) and (g) of Article 1(6) which have been legally placed on the market or put into service in accordance with the rules in force in the Member States prior to 26 May 2020 may continue to be placed on the market and put into service in the Member States concerned.
se člen 102 uporablja od 26. maja 2018;
Clinical investigations which have started to be conducted in accordance with Article 10 of Directive 90/385/EEC or Article 15 of Directive 93/42/EEC prior to 26 May 2020 may continue to be conducted.
se brez poseganja v obveznosti Komisije v skladu s členom 34 v primeru, ko zaradi okoliščin, ki jih ni bilo mogoče predvideti pri pripravi načrta iz člena 34(1), Eudamed 26. maja 2020 še ne deluje v celoti, obveznosti in zahteve, ki se nanašajo na Eudamed, uporabljajo od datuma, ki ustreza šestim mesecem po objavi obvestila iz člena 34(3).
As of 26 May 2020, however, the reporting of serious adverse events and device deficiencies shall be carried out in accordance with this Regulation.
Določbe iz prejšnjega stavka so:
Until the Commission has designated, pursuant to Article 27(2), issuing entities, GS1, HIBCC and ICCBBA shall be considered to be designated issuing entities.
člen 29,
Article 121
člen 31,
By 27 May 2027, the Commission shall assess the application of this Regulation and produce an evaluation report on the progress towards achievement of the objectives contained herein including an assessment of the resources required to implement this Regulation.
člen 33(4),
Special attention shall be given to the traceability of medical devices through the storage, pursuant to Article 27, of the UDI by economic operators, health institutions and health professionals.
drugi stavek člena 40(2),
Article 122
člen 42(10),
Repeal
člen 43(2),
Without prejudice to Articles 120(3) and (4) of this Regulation, and without prejudice to the obligations of the Member States and manufacturers as regards vigilance and to the obligations of manufacturers as regards the making available of documentation, under Directives 90/385/EEC and 93/42/EEC, those Directives are repealed with effect from 26 May 2020, with the exception of:
drugi pododstavek člena 44(12),
Articles 8 and 10, points (b) and (c) of Article 10b(1), Article 10b(2) and Article 10b(3) of Directive 90/385/EEC, and the obligations relating to vigilance and clinical investigations provided for in the corresponding Annexes, which are repealed with effect from the later of the dates referred to in point (d) of Article 123(3) of this Regulation;
točki (d) in (e) člena 46(7);
Article 10a and point (a) of Article 10b(1) of Directive 90/385/EEC, and the obligations relating to registration of devices and economic operators, and to certificate notifications, provided for in the corresponding Annexes, which are repealed with effect from 18 months after the later of the dates referred to in point (d) of Article 123(3) of this Regulation;
člen 53(2),
Article 10, points (c) and (d) of Article 14a(1), Article 14a(2), Article 14a(3) and Article 15 of Directive 93/42/EEC, and the obligations relating to vigilance and clinical investigations provided for in the corresponding Annexes, which are repealed with effect from the later of the dates referred to in point (d) of Article 123(3) of this Regulation; and
člen 54(3),
Article 14(1) and (2) and points (a) and (b) of Article 14a(1) of Directive 93/42/EEC, and the obligations relating to registration of devices and economic operators, and to certificate notifications, provided for in the corresponding Annexes, which are repealed with effect from 18 months after the later of the dates referred to in point (d) of Article 123(3) of this Regulation.
člen 55(1),
As regards the devices referred to in Article 120 (3) and (4) of this Regulation, the Directives referred to in the first paragraph shall continue to apply until 27 May 2025 to the extent necessary for the application of those paragraphs.
členi 70 do 77,
Notwithstanding the first paragraph, Regulations (EU) No 207/2012 and (EU) No 722/2012 shall remain in force and continue to apply unless and until repealed by implementing acts adopted by the Commission pursuant to this Regulation.
odstavki 1 do 13 člena 78,
References to the repealed Directives shall be understood as references to this Regulation and shall be read in accordance with the correlation table laid down in Annex XVII to this Regulation.
členi 79 do 82,
Article 123
člen 86(2),
Entry into force and date of application
člena 87 in 88,
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
člen 89(5) in (7) ter tretji pododstavek člena 89(8),
It shall apply from 26 May 2020.
člen 90,
By way of derogation from paragraph 2:
člen 93(4), (7) in (8),
Articles 35 to 50 shall apply from 26 November 2017.
člen 95(2) in (4),
However, from that date until 26 May 2020, the obligations on notified bodies pursuant to Articles 35 to 50 shall apply only to those bodies which submit an application for designation in accordance with Article 38;
zadnji stavek člena 97(2),
Articles 101 and 103 shall apply from 26 November 2017;
člen 99(4),
Article 102 shall apply from 26 May 2018;
drugi stavek prvega pododstavka člena 120(3).