natgillin/translations-raw huggingface dataset:
For companion diagnostics the notified body shall in particular for every device consult a competent authority designated by the Member States in accordance with Directive 2001/83/EC or the EMA, as applicable, in accordance with the procedure set out in point (k) of Section 3 of Annex X.
Za pripomočke za dopolnilno diagnostiko se priglašeni organ za vsak pripomoček zlasti posvetuje s pristojnim organom, ki ga imenujejo države članice v skladu z Direktivo 2001/83/ES ali z EMA, kot je ustrezno, in sicer v skladu s postopkom, določenim v točki (k) oddelka 3 Priloge X.
Manufacturers of class B devices, other than devices for performance study, 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 Sections 4.4 to 4.8 of that Annex for at least one representative device per category of devices.
Pri proizvajalcih pripomočkov razreda B, razen pripomočkov za študijo učinkovitosti, se izvede ugotavljanje skladnosti, kot je določeno v poglavjih I in III Priloge IX, pa tudi ocena tehnične dokumentacije, kot je določeno v oddelkih 4.1 do 4.8 navedene priloge, in sicer najmanj enega reprezentativnega pripomočka na vsako kategorijo pripomočkov.
In addition to the procedures referred to in the first subparagraph, for devices for self-testing and near-patient testing, the manufacturer shall follow the procedure for assessment of the technical documentation set out in Section 5.1 of Annex IX.
Pri pripomočkih za samotestiranje in testiranje ob pacientu proizvajalec poleg postopkov iz prvega pododstavka izvede tudi postopek za oceno tehnične dokumentacije iz oddelka 5.1 Priloge IX.
Manufacturers of class A devices, other than devices for performance study, shall declare the conformity of their products by issuing the EU declaration of conformity referred to in Article 17, after drawing up the technical documentation set out in Annexes II and III.
Proizvajalci pripomočkov razreda A, razen pripomočkov za študijo učinkovitosti, potrdijo skladnost svojih izdelkov z izjavo EU o skladnosti iz člena 17 po pripravi tehnične dokumentacije, kot je določena v prilogah II in III.
However, if those devices are placed on the market in sterile condition, the manufacturer shall apply the procedures set out in Annex IX or in Annex XI.
Če pa so ti pripomočki dani na trg v sterilnem stanju, proizvajalec uporabi postopke, določene v Prilogi IX ali Prilogi XI.
Involvement of the notified body shall be limited to the aspects relating to establishing, securing and maintaining sterile conditions.
Vključitev priglašenega organa je omejena na vidike, ki so povezani z vzpostavljanjem, zagotavljanjem in ohranjanjem sterilnih pogojev.
Devices for performance studies shall be subject to the requirements set out in Articles 57 to 77.
Za pripomočke za študije učinkovitosti veljajo zahteve iz členov 57 do 77.
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 10 be made available in an official Union language(s) determined by that Member State.
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 10, dajo na voljo v uradnem jeziku ali uradnih jezikih Unije, kakor jih določi zadevna država članica.
In the absence of such requirement, those documents shall be available in any official Union language acceptable to the notified body.
Če te zahteve ni, so ti dokumenti na voljo v katerem koli uradnem jeziku Unije, ki je sprejemljiv za priglašeni organ.
The Commission may, by means of implementing acts, specify the 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:
Komisija lahko z izvedbenimi akti določi podrobno ureditev in postopkovne vidike z namenom zagotavljanja usklajene uporabe postopkov ugotavljanja skladnosti, ki jih opravljajo priglašeni organi, za naslednje vidike:
the frequency and the sampling basis of the assessment of the technical documentation on a representative basis as set out in third paragraph of Section 2.3. and in Section 3.5 of Annex IX, in the case of class C devices;
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 razreda C;
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;
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;
the frequency of samples of the manufactured devices or batches of class D devices to be sent to an EU reference laboratory designated under Article 100 in accordance with Section 4.12 of Annex IX and Section 5.1 of Annex XI; or
pogostost vzorcev proizvedenih pripomočkov ali serij pripomočkov razreda D, ki se pošljejo v referenčni laboratorij EU, imenovan na podlagi člena 100, v skladu z oddelkom 4.12 Priloge IX in oddelkom 5.1 Priloge XI ali
the physical, laboratory or other tests to be carried out by notified bodies in the context of sample tests, assessment of technical documentation and type examination in accordance with Sections 3.4 and 4.3 of Annex IX and points (f) and (g) of Section 3. of Annex X.
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 ter točkama (f) in (g) oddelka 3 Priloge X.
Involvement of notified bodies in conformity assessment procedures
Vključenost priglašenih organov v postopke ugotavljanja skladnosti
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.
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 izvajanje dejavnosti ugotavljanja skladnosti v zvezi z zadevnimi vrstami pripomočkov.
The manufacturer may not lodge an application in parallel with another notified body for the same conformity assessment procedure.
Proizvajalec vloge za isti postopek ugotavljanja skladnosti ne sme vložiti hkrati pri drugem priglašenem organu.
The notified body concerned shall, by means of the electronic system referred to in Article 52, inform the other notified bodies of any manufacturer that withdraws its application prior to the notified body's decision regarding the conformity assessment.
Zadevni priglašeni organ prek elektronskega sistema iz člena 52 obvesti druge priglašene organe o vsakem proizvajalcu, ki svojo vlogo umakne pred odločitvijo priglašenega organa glede ugotavljanja skladnosti.
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.
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 predhodnih vlogah za isto ugotavljanje skladnosti, ki jih je drug priglašeni organ zavrnil.
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.
Priglašeni organ lahko od proizvajalca zahteva katere koli informacije ali podatke, ki so potrebni za ustrezno izvedbo izbranega postopka ugotavljanja skladnosti.
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 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.
Mechanism for scrutiny of conformity assessments of class D devices
Mehanizem za pregled ugotavljanja skladnosti pripomočkov razreda D
A notified body shall notify the competent authority of certificates it has granted for class D devices, with the exception of applications to supplement or renew existing certificates.
Priglašeni organ uradno obvesti pristojni organ o certifikatih, ki jih je izdal za pripomočke razreda D, razen vlog za dopolnitev ali podaljšanje obstoječih certifikatov.
Such notification shall take place through the electronic system referred to in Article 52 and shall include the instructions for use referred to in Section 20.4 of Annex I, the summary of safety and performance referred to in Article 29, the assessment report by the notified body, and, where applicable, the laboratory tests and the scientific opinion by the EU reference laboratory pursuant to the second subparagraph of Article 48(3), and where applicable the views expressed in accordance with Article 48(4) by the experts referred to in Article 106 of Regulation (EU) 2017/745.
Takšna uradna obvestitev se izvede prek elektronskega sistema iz člena 52, in vključujejo navodila za uporabo iz oddelka 20.4 Priloge I, povzetek o varnosti in učinkovitosti iz člena 29, ocenjevalno poročilo priglašenega organa ter po potrebi laboratorijski testi in znanstveno mnenje referenčnih laboratorijev EU v skladu z drugim pododstavkom člena 48(3), po potrebi pa tudi stališča, izražena v skladu s členom 48(4), ki so jih podali strokovnjaki iz člena 106 Uredbe (EU) 2017/745.
In the case of divergent views between the notified body and the experts, a full justification shall also be included.
V primeru različnih stališč priglašenega organa in strokovnjakov se vključi tudi ustrezna utemeljitev.
A competent authority and, where applicable, the Commission may, based on reasonable concerns apply further procedures in accordance with Article 40, 41, 42, 43 or 89 and, where deemed necessary, take appropriate measures in accordance with to Articles 90 and 92.
Pristojni organ in, kjer je to ustrezno, Komisija lahko na podlagi utemeljenih pomislekov uporabita nadaljnje postopke v skladu s členom 40, 41, 42, 43 ali 89 ter, če menita, da je to potrebno, sprejmeta ustrezne ukrepe v skladu s členoma 90 in 92.
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.
Koordinacijska skupina za medicinske pripomočke in, kadar je to ustrezno, Komisija lahko na podlagi utemeljenih pomislekov zahtevata znanstveno mnenje strokovnih odborov o varnosti in učinkovitosti pripomočka.
Certificates of conformity
Certifikati o skladnosti
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.
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.
The minimum content of the certificates shall be as set out in Annex XII.
Osnovna vsebina certifikatov je določena v Prilogi XII.
The certificates shall be valid for the period they indicate, which shall not exceed five years.
Certifikati so veljavni za navedeno obdobje, ki ne presega pet let.
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.
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.
Any supplement to a certificate shall remain valid as long as the certificate which it supplements is valid.
Vsako dopolnilo k certifikatu ostane veljavno, dokler je veljaven certifikat, na katerega se nanaša.
Notified bodies may impose restrictions to the intended purpose of a device to certain groups of patients or users or require manufacturers to undertake specific PMPF studies pursuant to Part B of Annex XIII.
Priglašeni organi lahko predvideni namen pripomočka omejijo na določene skupine pacientov ali uporabnikov oziroma od proizvajalcev zahtevajo, da v skladu z delom B Priloge XIII opravijo posebne študije spremljanja učinkovitosti po dajanju na trg.
Where a notified body finds that the requirements of this Regulation are no longer met by the manufacturer, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or impose any restrictions on it unless compliance with such requirements is ensured by appropriate corrective action taken by the manufacturer within an appropriate deadline set by the notified body.
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 notified body shall give the reasons for its decision.
Priglašeni organ obrazloži svojo odločitev.
The notified body shall enter in the electronic system referred to in Article 52 any information regarding certificates issued, including amendments and supplements thereto, and regarding suspended, reinstated, withdrawn or refused certificates and restrictions imposed on certificates.
Priglašeni organ v elektronski sistem iz člena 52 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.
Such information shall be accessible to the public.
Te informacije so dostopne javnosti.
In the light of technical progress, the Commission is empowered to adopt delegated acts in accordance with Article 108 amending the minimum content of the certificates set out in Annex XII.
Ker se tehnologija nenehno razvija, je na Komisijo preneseno pooblastilo za sprejemanje delegiranih aktov v skladu s členom 108, ki spreminjajo osnovno vsebino certifikatov iz Priloge XII.
Electronic system on notified bodies and on certificates of conformity
Elektronski sistem za priglašene organe in certifikate o skladnosti
For the purposes of this Regulation, the following information shall be collated and processed pursuant to Article 57 of Regulation (EU) 2017/745 in the electronic system set up in accordance with that Article:
Za namene te uredbe se v skladu s členom 57 Uredbe (EU) 2017/745 v elektronskem sistemu, vzpostavljenem v skladu z navedenim členom, zbirajo in obdelujejo naslednje informacije:
the list of subsidiaries referred to in Article 33(2);
seznam odvisnih družb iz člena 33(2);
the list of experts referred to in Article 36(2);
seznam strokovnjakov iz člena 36(2);
the information relating to the notification referred to in Article 38(10) and the amended notifications referred to in Article 42(2);
informacije v zvezi s priglasitvijo iz člena 38(10) in spremembe v zvezi s priglasitvijo iz člena 42(2);
the list of notified bodies referred to in Article 39(2);
seznam priglašenih organov iz člena 39(2);
the summary of the report referred to in Article 40(12);
povzetek poročila iz člena 40(12);
the notifications for conformity assessments and certificates referred to in Article 50(1);
priglasitve za ugotavljanje skladnosti in certifikati iz člena 50(1);
withdrawal or refusals of applications for the certificates as referred to in Article 49(2) and Section 4.3 of Annex VII;
umik ali zavrnitev vlog za certifikate iz člena 49(2) in oddelka 4.3 Priloge VII;
the information regarding certificates referred to in Article 51(5);
informacije o certifikatih iz člena 51(5);
the summary of safety and performance referred to in Article 29.
povzetek o varnosti in učinkovitosti iz člena 29.
Voluntary change of notified body
Prostovoljna zamenjava priglašenega organa
In cases where a manufacturer terminates its contract with a notified body and enters into a contract with another notified body in respect of the conformity assessment of the same device, the detailed arrangements for the change of notified body shall be clearly defined in an agreement between the manufacturer, the incoming notified body and, where practicable the outgoing notified body.
Kadar proizvajalec prekine pogodbo s priglašenim organom in sklene pogodbo z drugim priglašenim organom za ugotavljanje skladnosti istega pripomočka, se podrobna ureditev zamenjave priglašenega organa jasno določi v sporazumu med proizvajalcem, novim priglašenim organom in, kadar je to izvedljivo, dotedanjim priglašenim organom.
That agreement shall cover at least the following aspects:
Ta sporazum zajema vsaj:
the date on which the certificates issued by the outgoing notified body become invalid;
datum izteka veljavnosti certifikatov, ki jih je izdal dotedanji priglašeni organ;
the date until which the identification number of the outgoing notified body may be indicated in the information supplied by the manufacturer, including any promotional material;
datum, do katerega je identifikacijska številka dotedanjega priglašenega organa lahko navedena v informacijah, ki jih predloži proizvajalec, vključno s promocijskim gradivom;
the date after which the conformity assessment tasks of the outgoing notified body is assigned to the incoming notified body;
datum, po katerem se naloge ugotavljanja skladnosti z dotedanjega priglašenega organa prenesejo na novi priglašeni organ;
the last serial number or lot number for which the outgoing notified body is responsible.
zadnjo serijsko številko ali številko partije, za katero je odgovoren dotedanji priglašeni organ.
The outgoing notified body shall withdraw the certificates it has issued for the device concerned on the date on which they become invalid.
Dotedanji priglašeni organ prekliče certifikate, ki jih je izdal za zadevni pripomoček, na datum izteka njihove veljavnosti.
Derogation from the conformity assessment procedures
Odstopanje od postopkov ugotavljanja skladnosti
By way of derogation from Article 48, any competent authority may authorise, on a duly justified request, the placing on the market or putting into service, within the territory of the Member State concerned, of a specific device for which the procedures referred to in that Article have not been carried out but use of which is in the interest of public health or patient safety or health.
Z odstopanjem od člena 48 lahko vsak pristojni organ na podlagi utemeljene zahteve na ozemlju zadevne države članice odobri dajanje na trg ali v uporabo posameznega pripomočka, za katerega sicer niso bili opravljeni postopki iz navedenega člena, a je njegova uporaba v interesu varovanja javnega zdravja ali varnosti ali zdravja pacientov.
The Member State shall inform the Commission and the other Member States of any decision to authorise the placing on the market or putting into service of a device in accordance with paragraph 1 where such authorisation is granted for use other than for a single patient.
Država članica obvesti Komisijo in druge države članice o vsaki odločitvi o odobritvi dajanja pripomočka na trg ali v uporabo v skladu z odstavkom 1, če taka odobritev velja za več kot enega pacienta.
Following a notification pursuant to paragraph 2 of this Article, the Commission, in exceptional cases relating to public health or patient safety or health, may, by means of implementing acts, extend for a limited period of time the validity of an authorisation granted by a Member State in accordance with paragraph 1 of this Article to the territory of the Union and set the conditions under which the device may be placed on the market or put into service.
Po obvestilu iz odstavka 2 tega člena lahko Komisija v izjemnih primerih, povezanih z javnim zdravjem ali varnostjo ali zdravjem pacientov, z izvedbenimi akti za omejen čas podaljša veljavnost dovoljenja, ki ga je država članica izdala v skladu z odstavkom 1 tega člena na ozemlju Unije, in določi pogoje, pod katerimi se lahko pripomoček daje na trg ali v uporabo.
On duly justified imperative grounds of urgency relating to the health and safety of humans, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 107(4).
Komisija na podlagi ustrezno utemeljenih nujnih razlogov v zvezi z zdravjem in varnostjo ljudi ter v skladu s postopkom iz člena 107(4) sprejme izvedbene akte, ki se začnejo takoj uporabljati.
Certificate of free sale
Certifikat o prosti prodaji
For the purpose of export and upon request by a manufacturer or an authorised representative, the Member State in which the manufacturer or the authorised representative has its registered place of business shall issue a certificate of free sale declaring that the manufacturer or the authorised representative, as applicable, has its registered place of business on its territory and that the device in question bearing the CE-marking in accordance with this Regulation may be marketed in the Union.
Država članica, v kateri ima proizvajalec ali pooblaščeni predstavnik registrirani kraj poslovanja, za namen izvoza in na zahtevo proizvajalca ali pooblaščenega predstavnika izda certifikat o prosti prodaji, v katerem je navedeno, da ima proizvajalec ali pooblaščeni predstavnik, kot je ustrezno, registrirani kraj poslovanja na njenem ozemlju in da se lahko zadevni pripomoček z oznako CE v skladu s to uredbo trži v Uniji.
The certificate of free sale shall set out the Basic UDI-DI of the device as provided to the UDI database under Article 26.
V certifikatu o prosti prodaji se navede osnovni UDI-DI, kot je določen v podatkovni zbirki UDI iz člena 26.
Where a notified body has issued a certificate pursuant to Article 51, the certificate of free sale shall set out the unique number identifying the certificate issued by the notified body, as referred to in Section 3 of Chapter II of Annex XII.
Kadar priglašeni organ izda certifikat v skladu s členom 51, se v certifikatu o prosti prodaji navede edinstvena identifikacijska številka certifikata, ki ga je izdal priglašeni organ, v skladu z oddelkom 3 poglavja II Priloge XII.
The Commission may, by means of implementing acts, establish a model for certificates of free sale, taking into account international practice as regards the use of certificates of free sale.
Komisija lahko z izvedbenimi akti določi vzorec certifikata o prosti prodaji ob upoštevanju mednarodne prakse v zvezi z uporabo certifikatov o prosti prodaji.