natgillin/translations-raw huggingface dataset:
Prior to placing a device on the market, manufacturers shall undertake an assessment of the conformity of that device, in accordance with the applicable conformity assessment procedures set out in Annexes IX to XI.
Pri pripomočkih iz prvega pododstavka člena 1(8) se poleg postopkov, ki se uporabljajo na podlagi odstavka 3, 4, 6 ali 7 tega člena, uporablja tudi postopek, opredeljen v oddelku 5.2 Priloge I ali oddelku 6 Priloge X, kot je ustrezno.
Prior to putting into service a device that is not placed on the market, manufacturers shall undertake an assessment of the conformity of that device, in accordance with the applicable conformity assessment procedures set out in Annexes IX to XI.
Pri pripomočkih, ki so zajeti v tej uredbi v skladu s točko (f) ali (g) člena 1(6) in s prvim pododstavkom člena 1(10), se poleg postopkov, ki se uporabljajo na podlagi odstavka 3, 4, 6 ali 7 tega člena, uporablja tudi postopek, opredeljen v oddelku 5.3 Priloge IX ali oddelku 6 Priloge X, kot je ustrezno.
3.
Pri pripomočkih, sestavljenih iz snovi ali kombinacij snovi, ki so namenjene vnosu v človeško telo skozi telesno odprtino ali se nanesejo na kožo in jih človeško telo absorbira ali pa se po njem lokalno razpršijo, se poleg postopkov, ki se uporabljajo na podlagi odstavka 3, 4, 6 ali 7, uporablja tudi postopek, opredeljen v oddelku 5.4 Priloge IX ali oddelku 6 Priloge X, kot je ustrezno.
Manufacturers of class III devices, other than custom-made or investigational devices, shall be subject to a conformity assessment as specified in Annex IX.
Država članica, v kateri ima priglašeni organ sedež, lahko zahteva, da se vsi ali nekateri dokumenti, vključno s tehnično dokumentacijo, poročili o presojah, poročili o oceni in poročili o inšpekcijskih pregledih, povezani s postopki iz odstavkov 1 do 7 in 9 do 11, dajo na voljo v uradnem jeziku ali jezikih Unije, kakor jih določi zadevna država članica.
Alternatively, the manufacturer may choose to apply a conformity assessment as specified in Annex X coupled with a conformity assessment as specified in Annex XI.
Če te zahteve ni, so ti dokumenti na voljo v katerem koli uradnem jeziku Unije, ki je sprejemljiv za priglašeni organ.
Manufacturers of class IIb devices, other than custom-made or investigational devices, shall be subject to a conformity assessment as specified in Chapters I and III of Annex IX, and including an assessment of the technical documentation as specified in Section 4 of that Annex of at least one representative device per generic device group.
Za pripomočke, ki so predmet raziskave, veljajo zahteve iz členov od 62 do 81.
However, for class IIb implantable devices, except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors, the assessment of the technical documentation as specified in Section 4 of Annex IX shall apply for every device.
Komisija lahko glede naslednjega z izvedbenimi akti določi podrobno ureditev in postopkovne vidike, da zagotovi, da bodo priglašeni organi usklajeno izvajali postopke ugotavljanja skladnosti:
Alternatively, the manufacturer may choose to apply a conformity assessment based on type examination as specified in Annex X coupled with a conformity assessment based on product conformity verification as specified in Annex XI.
pogostost vzorčenja in število vzorcev pri oceni tehnične dokumentacije na reprezentativni podlagi, kot je določeno v tretjem odstavku oddelka 2.3 in v oddelku 3.5 Priloge IX v primeru pripomočkov razredov IIa in IIb ter v oddelku 10.2 Priloge XI v primeru pripomočkov razreda IIa, ali
Where justified in view of well-established technologies, similar to those used in the exempted devices listed in the second subparagraph of paragraph 4 of this Article, being used in other class IIb implantable devices, or where justified in order to protect the health and safety of patients, users or other persons or other aspects of public health, the Commission is empowered to adopt delegated acts in accordance with Article 115 to amend that list by adding other types of class IIb implantable devices to that list or removing devices therefrom.
minimalna pogostost nenapovedanih presoj na kraju samem in testiranj vzorcev, ki jih priglašeni organi izvajajo v skladu z oddelkom 3.4 Priloge IX, pri čemer se upoštevata razred tveganja in vrsta pripomočka, ali
Manufacturers of class IIa devices, other than custom-made or investigational devices, shall be subject to a conformity assessment as specified in Chapters I and III of Annex IX, and including an assessment of the technical documentation as specified in Section 4 of that Annex of at least one representative device for each category of devices.
fizikalni, laboratorijski ali drugi testi, ki jih priglašeni organi izvajajo v okviru testiranja vzorcev, ocene tehnične dokumentacije in pregleda tipa v skladu z oddelkoma 3.4 in 4.3 Priloge IX, oddelkom 3 Priloge X ter oddelkom 15 Priloge XI.
Alternatively, the manufacturer may choose to draw up the technical documentation set out in Annexes II and III coupled with a conformity assessment as specified in Section 10 or Section 18 of Annex XI.
Člen 53
The assessment of the technical documentation shall apply for at least one representative device for each category of devices.
Vključenost priglašenih organov v postopke ugotavljanja skladnosti
Manufacturers of class I devices, other than custom-made or investigational devices, shall declare the conformity of their products by issuing the EU declaration of conformity referred to in Article 19 after drawing up the technical documentation set out in Annexes II and III.
Kadar mora biti v postopek ugotavljanja skladnosti vključen priglašeni organ, lahko proizvajalec vloži vlogo pri priglašenem organu, ki ga sam izbere, pod pogojem, da je izbrani priglašeni organ imenovan za ugotavljanje skladnosti v zvezi z zadevnimi vrstami pripomočkov.
If those devices are placed on the market in sterile condition, have a measuring function or are reusable surgical instruments, the manufacturer shall apply the procedures set out in Chapters I and III of Annex IX, or in Part A of Annex XI.
Proizvajalec vloge za isti postopek ugotavljanja skladnosti ne sme vložiti hkrati pri drugem priglašenem organu.
However, the involvement of the notified body in those procedures shall be limited:
Zadevni priglašeni organ prek elektronskega sistema iz člena 57 druge priglašene organe obvesti, če kakšen proizvajalec svojo vlogo umakne, preden zadevni priglašeni organ sprejme odločitev glede ugotavljanja skladnosti.
in the case of devices placed on the market in sterile condition, to the aspects relating to establishing, securing and maintaining sterile conditions;
Proizvajalci pri predložitvi vloge priglašenemu organu na podlagi odstavka 1 navedejo, ali so pred odločitvijo tega priglašenega organa umaknili vlogo pri drugem priglašenem organu, in navedejo informacije o morebitnih predhodnih vlogah za isto ugotavljanje skladnosti, ki jih je drug priglašeni organ zavrnil.
in the case of devices with a measuring function, to the aspects relating to the conformity of the devices with the metrological requirements;
Priglašeni organ lahko od proizvajalca zahteva katere koli informacije ali podatke, ki so potrebni za ustrezno izvedbo izbranega postopka ugotavljanja skladnosti.
in the case of reusable surgical instruments, to the aspects relating to the reuse of the device, in particular cleaning, disinfection, sterilization, maintenance and functional testing and the related instructions for use.
Priglašeni organi in njihovo osebje izvajajo dejavnosti ugotavljanja skladnosti z največjo poklicno integriteto in potrebno tehnično in znanstveno usposobljenostjo na določenem področju, brez pritiskov in spodbud, zlasti finančnih, ki bi lahko vplivali na njihovo presojo ali rezultate njihovih dejavnosti ugotavljanja skladnosti, zlasti s strani oseb ali skupin, za katere so rezultati navedenih dejavnosti pomembni.
Manufacturers of custom-made devices shall follow the procedure set out in Annex XIII and draw up the statement set out in Section 1 of that Annex before placing such devices on the market.
Člen 54
In addition to the procedure applicable pursuant to the first subparagraph, manufacturers of class III custom-made implantable devices shall be subject to the conformity assessment as specified in Chapter I of Annex IX.
Postopek za posvetovanje o klinični oceni za nekatere pripomočke razredov III in IIb
Alternatively, the manufacturer may choose to apply a conformity assessment as specified in Part A of Annex XI.
Poleg postopkov, ki se uporabljajo v skladu z odstavkom 52, priglašeni organ pri ugotavljanju skladnosti naslednjih pripomočkov sledi tudi postopku za posvetovanje o klinični oceni, kot je določen v oddelku 5.1 Priloge IX ali v oddelku 6 Priloge X, kakor je ustrezno:
In addition to the procedures applicable pursuant to paragraph 3, 4, 6, or 7 of this Article, in the case of devices referred to in the first subparagraph of Article 1(8), the procedure specified in Section 5.2 of Annex IX or Section 6 of Annex X, as applicable, shall also apply.
pripomočkov za vsaditev razreda III in
In addition to the procedures applicable pursuant to paragraph 3, 4, 6, or 7 of this Article, in the case of devices that are covered by this Regulation in accordance with point (f) or (g) of Article 1(6) and with the first subparagraph of Article 1(10), the procedure specified in Section 5.3 of Annex IX or Section 6 of Annex X, as applicable, shall also apply.
aktivnih pripomočkov razreda IIb, namenjenih dajanju in/ali odstranjevanju zdravil, iz oddelka 6.4.
In addition to the procedures applicable pursuant to paragraph 3, 4, 6, or 7, in the case of devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed in the human body, the procedure specified in Section 5.4 of Annex IX or Section 6 of Annex X, as applicable, shall also apply.
Priloge VIII (pravilo 12).
The Member State in which the notified body is established may require that all or certain documents, including the technical documentation, audit, assessment and inspection reports, relating to the procedures referred to in paragraphs 1 to 7 and 9 to 11 be made available in an official Union language(s) determined by that Member State.
Postopek iz odstavka 1 se ne zahteva za v njem navedene pripomočke:
In the absence of such requirement, those documents shall be available in any official Union language acceptable to the notified body.
v primeru podaljšanja certifikata, izdanega v skladu s to uredbo;
Investigational devices shall be subject to the requirements set out in Articles 62 to 81.
če je pripomoček zasnovan kot spremenjena različica pripomočka, ki ga je isti proizvajalec že tržil za isti predvideni namen, in je proizvajalec dokazal, da spremembe ne poslabšujejo razmerja med koristmi in tveganji pripomočka, priglašeni organ pa se je s tem strinjal, ali
The Commission may, by means of implementing acts, specify detailed arrangements and procedural aspects with a view to ensuring the harmonised application of the conformity assessment procedures by the notified bodies for any of the following aspects:
če so načela za klinično oceno vrste ali kategorije pripomočka opredeljena v enotni specifikaciji iz člena 9, priglašeni organ pa potrdi, da je klinična ocena proizvajalca za ta pripomoček v skladu z ustrezno enotno specifikacijo za klinično oceno tovrstnega pripomočka.
the frequency and the sampling basis of the assessment of the technical documentation on a representative basis as set out in the third paragraph of Section 2.3 and in Section 3.5 of Annex IX in the case of class IIa and class IIb devices, and in Section 10.2 of Annex XI in the case of class IIa devices;
Priglašeni organ prek elektronskega sistema iz člena 57 uradno obvesti organ, pristojen za priglašene organe, in Komisijo o tem, ali je treba uporabiti postopek iz odstavka 1 ali ne.
the minimum frequency of unannounced on-site audits and sample tests to be conducted by notified bodies in accordance with Section 3.4 of Annex IX, taking into account the risk-class and the type of device;
Temu obvestilu priloži poročilo o vrednotenju klinične ocene.
the physical, laboratory or other tests to be carried out by notified bodies in the context of sample tests, assessment of the technical documentation and type examination in accordance with Sections 3.4 and 4.3 of Annex IX, Section 3 of Annex X and Section 15 of Annex XI.
Komisija pripravi letni pregled pripomočkov, za katere je bil uporabljen postopek, opredeljen v oddelku 5.1 Priloge IX oziroma naveden v oddelku 6 Priloge X.
Article 53
Letni pregled vključuje obveščanje v skladu z odstavkom 3 tega člena in točko (e) oddelka 5.1 Priloge IX ter beleženje primerov, v katerih priglašeni organ ni upošteval mnenja strokovnega odbora.
Involvement of notified bodies in conformity assessment procedures
Komisija ta pregled pošlje Evropskemu parlamentu, Svetu in Koordinacijski skupini za medicinske pripomočke.
Where the conformity assessment procedure requires the involvement of a notified body, the manufacturer may apply to a notified body of its choice, provided that the chosen notified body is designated for conformity assessment activities related to the types of devices concerned.
Komisija do 27. maja 2025 pripravi poročilo o izvajanju tega člena ter ga predloži Evropskemu parlamentu in Svetu.
The manufacturer may not lodge an application in parallel with another notified body for the same conformity assessment procedure.
V poročilu upošteva letne preglede in vsa razpoložljiva ustrezna priporočila Koordinacijske skupine za medicinske pripomočke.
The notified body concerned shall, by means of the electronic system referred to in Article 57, inform the other notified bodies of any manufacturer that withdraws its application prior to the notified body's decision regarding the conformity assessment.
Komisija na podlagi tega poročila po potrebi pripravi predloge za spremembo te uredbe.
When applying to a notified body under paragraph 1, manufacturers shall declare whether they have withdrawn an application with another notified body prior to the decision of that notified body and provide information about any previous application for the same conformity assessment that has been refused by another notified body.
Člen 55
The notified body may require any information or data from the manufacturer, which is necessary in order to properly conduct the chosen conformity assessment procedure.
Mehanizem za pregled ugotavljanja skladnosti nekaterih pripomočkov razredov III in IIb
Notified bodies and the personnel of notified bodies shall carry out their conformity assessment activities with the highest degree of professional integrity and the requisite technical and scientific competence in the specific field and shall be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of their conformity assessment activities, especially as regards persons or groups with an interest in the results of those activities.
Priglašeni organ uradno obvesti pristojne organe o certifikatih, ki jih je izdal za pripomočke, za katere je bil opravljen postopek ugotavljanja skladnosti v skladu s členom 54(1).
Article 54
Takšna uradna obvestila se pošljejo prek elektronskega sistema iz člena 57 in vključujejo povzetek o varnosti in klinični učinkovitosti v skladu s členom 32, ocenjevalno poročilo priglašenega organa, navodila za uporabo iz oddelka 23.4 Priloge I in, kjer je ustrezno, znanstveno mnenje strokovnih odborov iz oddelka 5.1 Priloge IX ali oddelka 6 Priloge X, kot je ustrezno.
Clinical evaluation consultation procedure for certain class III and class IIb devices
V primeru različnih stališč priglašenega organa in strokovnih odborov se vključi tudi ustrezna utemeljitev.
In addition to the procedures applicable pursuant to Article 52, a notified body shall also follow the procedure regarding clinical evaluation consultation as specified in Section 5.1 of Annex IX or as referred to in Section 6 of Annex X, as applicable, when performing a conformity assessment of the following devices:
Pristojni organ in, kjer je ustrezno, Komisija lahko na podlagi utemeljenih pomislekov uporabita nadaljnje postopke v skladu s členom 44, 45, 46, 47 ali 94 ter po potrebi sprejmeta ustrezne ukrepe v skladu s členoma 95 in 97.
class III implantable devices, and
Koordinacijska skupina za medicinske pripomočke in, kjer je ustrezno, Komisija lahko na podlagi utemeljenih pomislekov zahteva znanstveno mnenje strokovnih odborov o varnosti in učinkovitosti pripomočka.
class IIb active devices intended to administer and/or remove a medicinal product, as referred to in Section 6.4 of Annex VIII (Rule 12).
Člen 56
The procedure referred to in paragraph 1 shall not be required for the devices referred to therein:
Certifikati o skladnosti
in the case of renewal of a certificate issued under this Regulation;
Certifikati, ki jih izdajo priglašeni organi v skladu s prilogami IX, X in XI, so v uradnem jeziku Unije, ki ga določi država članica, v kateri je sedež priglašenega organa, ali v uradnem jeziku Unije, ki je sprejemljiv za priglašeni organ.
where the device has been designed by modifying a device already marketed by the same manufacturer for the same intended purpose, provided that the manufacturer has demonstrated to the satisfaction of the notified body that the modifications do not adversely affect the benefit-risk ratio of the device; or
Osnovna vsebina certifikata je določena v Prilogi XII.
where the principles of the clinical evaluation of the device type or category have been addressed in a CS referred to in Article 9 and the notified body confirms that the clinical evaluation of the manufacturer for this device is in compliance with the relevant CS for clinical evaluation of that kind of device.
Certifikati so veljavni za obdobje, ki je v njih navedeno in ki ne presega pet let.
The notified body shall notify the competent authorities, the authority responsible for notified bodies and the Commission through the electronic system referred to in Article 57 of whether or not the procedure referred to in paragraph 1 of this Article is to be applied.
Na predlog proizvajalca se lahko veljavnost certifikata na podlagi ponovne ocene v skladu z veljavnimi postopki za ugotavljanje skladnosti podaljša za nadaljnja obdobja, pri čemer posamezno obdobje ne sme preseči pet let.
That notification shall be accompanied by the clinical evaluation assessment report.
Vsako dopolnilo k certifikatu ostane veljavno, dokler je veljaven certifikat, ki ga to dopolnjuje.
The Commission shall draw up an annual overview of devices which have been subject to the procedure specified in Section 5.1 of Annex IX and referred to in Section 6 of Annex X.
Priglašeni organi lahko predvideni namen pripomočka omejijo na določene skupine pacientov oziroma od proizvajalcev zahtevajo, da v skladu z delom B Priloge XIV opravijo posebne študije kliničnega spremljanja po dajanju na trg.
The annual overview shall include the notifications in accordance with paragraph 3 of this Article and point (e) of Section 5.1 of Annex IX and a listing of the cases where the notified body did not follow the advice from the expert panel.
Če priglašeni organ ugotovi, da proizvajalec ne izpolnjuje več zahtev iz te uredbe, ob upoštevanju načela sorazmernosti začasno ali trajno prekliče izdan certifikat oziroma ga omeji, razen če skladnost s takimi zahtevami zagotavljajo ustrezni korektivni ukrepi, ki jih je proizvajalec sprejel v ustreznem roku, ki ga določi priglašeni organ.
The Commission shall submit this overview to the European Parliament, to the Council and to the MDCG.
Priglašeni organ obrazloži svojo odločitev.
The Commission shall by 27 May 2025 draw up a report on the operation of this Article and submit it to the European Parliament and to the Council.
Priglašeni organ v elektronski sistem iz člena 57 vnese vse informacije v zvezi z izdanimi certifikati, vključno z njihovimi spremembami in dopolnili, in v zvezi z začasno preklicanimi, ponovno uvedenimi, preklicanimi ali zavrnjenimi certifikati ter omejitvami za certifikate.
The report shall take into account the annual overviews and any available relevant recommendations from the MDCG.
Te informacije so dostopne javnosti.
On the basis of that report the Commission shall, if appropriate, make proposals for amendments to this Regulation.
Ker se tehnologija nenehno razvija, je na Komisijo preneseno pooblastilo za sprejemanje delegiranih aktov v skladu s členom 115, s katerimi se spreminja osnovna vsebina certifikatov iz Priloge XII.
Article 55
Člen 57
Mechanism for scrutiny of conformity assessments of certain class III and class IIb devices
Elektronski sistem o priglašenih organih in certifikatih o skladnosti
A notified body shall notify the competent authorities of certificates it has granted to devices for which the conformity assessment has been performed pursuant to Article 54(1).
Komisija po posvetovanju s Koordinacijsko skupino za medicinske pripomočke vzpostavi in upravlja elektronski sistem za zbiranje in obdelavo naslednjih informacij:
Such notification shall take place through the electronic system referred to in Article 57 and shall include the summary of safety and clinical performance pursuant to Article 32, the assessment report by the notified body, the instructions for use referred to in Section 23.4 of Annex I, and, where applicable, the scientific opinion of the expert panels referred to in Section 5.1 of Annex IX or Section 6 of Annex X, as applicable.
seznam odvisnih družb iz člena 37(3);
In the case of divergent views between the notified body and the expert panels, a full justification shall also be included.
seznam strokovnjakov iz člena 40(2);
A competent authority and, where applicable, the Commission may, based on reasonable concerns apply further procedures in accordance with Article 44, 45, 46, 47 or 94 and, where deemed necessary, take appropriate measures in accordance with Articles 95 and 97.
informacije v zvezi s priglasitvijo iz člena 42(10) in spremembe v zvezi s priglasitvijo iz člena 46(2);
The MDCG and, where applicable, the Commission, may, based on reasonable concerns, request scientific advice from the expert panels in relation to the safety and performance of any device.
seznam priglašenih organov iz člena 43(2);
Article 56
povzetek poročila iz člena 44(12);
Certificates of conformity
priglasitve ugotavljanja skladnosti in certifikati iz člena 54(3) in člena 55(1);
The certificates issued by the notified bodies in accordance with Annexes IX, X and XI shall be in an official Union language determined by the Member State in which the notified body is established or otherwise in an official Union language acceptable to the notified body.
umik ali zavrnitve vlog za certifikate iz člena 53(2) in oddelka 4.3 Priloge VII;
The minimum content of the certificates shall be as set out in Annex XII.
informacije o certifikatih iz člena 56(5);
The certificates shall be valid for the period they indicate, which shall not exceed five years.
povzetek o varnosti in klinični učinkovitosti iz člena 32.
On application by the manufacturer, the validity of the certificate may be extended for further periods, each not exceeding five years, based on a re-assessment in accordance with the applicable conformity assessment procedures.
Informacije, zbrane in obdelane v elektronskem sistemu, so dostopne pristojnim organom držav članic, Komisiji in, če je ustrezno, priglašenim organom ter širši javnosti, če je tako določeno drugje v tej uredbi ali Uredbi (EU) 2017/746.
Any supplement to a certificate shall remain valid as long as the certificate which it supplements is valid.
Člen 58
Notified bodies may impose restrictions to the intended purpose of a device to certain groups of patients or require manufacturers to undertake specific PMCF studies pursuant to Part B of Annex XIV.
Prostovoljna zamenjava priglašenega organa