natgillin/translations-raw huggingface dataset:
observe the manufacturer's and competent authority's activities and the results of the manufacturer's investigation so as to determine whether the certification granted is at risk or whether adequate corrective action has been taken,
za pregled ustreznih virov znanstvenih in kliničnih podatkov ter informacij po dajanju na trg v zvezi s področjem, za katerega so imenovani.
perform extraordinary surveillance measures, such as document reviews, short-notice or unannounced audits and product testing, where it is likely that the certification granted is at risk,
Te informacije je treba upoštevati pri načrtovanju in izvajanju dejavnosti nadzora, in
increase the frequency of surveillance audits,
za pregled podatkov o vigilanci, do katerih imajo dostop v skladu s členom 92(2), da se oceni njihov morebiten vpliv na veljavnost obstoječih certifikatov.
review specific products or processes on the occasion of the next audit of the manufacturer, or
Rezultati ocene in vse sprejete odločitve se natančno dokumentirajo.
take any other relevant measure.
Potem ko zadevni priglašeni organ od proizvajalca ali pristojnih organov prejme informacije o primerih vigilance, odloči o tem, katera od naslednjih možnostih se uporabi:
In relation to surveillance audits of manufacturers, the notified body shall have documented procedures to:
ukrepanje ni potrebno na podlagi tega, da primer vigilance očitno ni povezan z izdanim certifikatom,
conduct surveillance audits of the manufacturer on at least an annual basis which shall be planned and conducted in line with the relevant requirements in Section 4.5,
preučijo se dejavnosti proizvajalca in pristojnih organov ter rezultati raziskave proizvajalca, da bi se določilo, ali je izdani certifikat ogrožen oziroma ali so bili sprejeti ustrezni korektivni ukrepi,
ensure adequate assessment of the manufacturer's documentation on, and application of the provisions on, vigilance, the post-market surveillance, and PMCF,
izvedejo se izredni nadzorni ukrepi, kot so pregledi dokumentacije, na kratek rok napovedane presoje ali nenapovedane presoje in preskušanje izdelkov, kadar je verjetno, da je izdani certifikat ogrožen,
sample and test devices and technical documentation, during audits, according to pre-defined sampling criteria and testing procedures to ensure that the manufacturer continuously applies the approved quality management system,
poveča se pogostost nadzornih presoj,
ensure that the manufacturer complies with the documentation and information obligations laid down in the relevant Annexes and that its procedures take into account best practices in the implementation of quality management systems,
ob naslednji presoji pri proizvajalcu se pregledajo posebni izdelki ali postopki ali
ensure that the manufacturer does not use quality management system or device approvals in a misleading manner,
sprejme se kateri koli drug ustrezen ukrep.
gather sufficient information to determine if the quality management system continues to comply with the requirements of this Regulation,
V zvezi z nadzornimi presojami pri proizvajalcih ima priglašeni organ vzpostavljene dokumentirane postopke, na podlagi katerih se:
ask the manufacturer, if non-conformities are detected, for corrections, corrective actions and, where applicable, preventive actions, and
najmanj enkrat letno izvedejo nadzorne presoje pri proizvajalcu, ki se načrtujejo in izvajajo v skladu z ustreznimi zahtevami iz oddelka 4.5.,
where necessary, impose specific restrictions on the relevant certificate, or suspend or withdraw it.
poskrbi za ustrezno oceno dokumentacije proizvajalca v zvezi z določbami o vigilanci, nadzorom po dajanju na trg in kliničnim spremljanjem po dajanju na trg ter njihovo uporabo,
The notified body shall, if listed as part of the conditions for certification:
vzorčijo in preskušajo pripomočki in tehnična dokumentacija med presojami, v skladu z vnaprej določenimi merili vzorčenja in postopki preskušanja, s čimer se zagotovi, da proizvajalec stalno uporablja odobreni sistem vodenja kakovosti,
conduct an in-depth review of the clinical evaluation as most recently updated by the manufacturer based on the manufacturer's post-market surveillance, on its PMCF and on clinical literature relevant to the condition being treated with the device or on clinical literature relevant to similar devices,
zagotovi, da proizvajalec izpolnjuje obveznosti glede dokumentacije in informacij, določene v zadevnih prilogah, in da pri svojih postopkih upošteva najboljše prakse na področju izvajanja sistemov vodenja kakovosti,
clearly document the outcome of the in-depth review and address any specific concerns to the manufacturer or impose any specific conditions on it, and
zagotovi, da proizvajalec odobritev sistema vodenja kakovosti ali pripomočka ne uporablja na zavajajoč način,
ensure that the clinical evaluation as most recently updated, is appropriately reflected in the instructions for use and, where applicable, the summary of safety and performance.
pridobijo zadostne informacije za ugotovitev, ali je sistem vodenja kakovosti še naprej v skladu z zahtevami te uredbe,
Re-certification
v primeru odkritja neskladnosti od proizvajalca zahtevajo popravki, korektivni ukrepi in, kjer je ustrezno, preventivni ukrepi ter
The notified body shall have documented procedures in place relating to the re-certification reviews and the renewal of certificates.
po potrebi uvedejo posebne omejitve za zadevni certifikat oziroma se certifikat začasno ali trajno prekliče.
Re-certification of approved quality management systems or EU technical documentation assessment certificates or EU type-examination certificates shall occur at least every five years.
Če je to del pogojev za certificiranje, priglašeni organ:
The notified body shall have documented procedures relating to renewals of EU technical documentation assessment certificates and EU type-examination certificates and those procedures shall require the manufacturer in question to submit a summary of changes and scientific findings for the device, including:
izvede poglobljen pregled klinične ocene, kakor jo je proizvajalec nazadnje posodobil na podlagi svojega nadzora po dajanju na trg, svojega kliničnega spremljanja po dajanju na trg in klinične literature v zvezi z zdravljenjem stanja s pripomočkom ali klinične literature v zvezi s podobnimi pripomočki,
all changes to the originally approved device, including changes not yet notified,
jasno dokumentira rezultat poglobljenega pregleda in proizvajalcu sporoči morebitne posebne pomisleke ali mu naloži morebitne posebne pogoje in
experience gained from post-market surveillance,
zagotovi, da se klinična ocena, kakor je bila nazadnje posodobljena, ustrezno upošteva v navodilih za uporabo in, kjer je ustrezno, zbirnem poročilu o varnosti in učinkovitosti.
experience from risk management,
Ponovno certificiranje
experience from updating the proof of compliance with the general safety and performance requirements set out in Annex I,
Priglašeni organ ima vzpostavljene dokumentirane postopke za preglede ponovnega certificiranja in podaljšanje veljavnosti certifikatov.
experience from reviews of the clinical evaluation, including the results of any clinical investigations and PMCF,
Ponovno certificiranje odobrenih sistemov za vodenje kakovosti ali certifikatov EU o oceni tehnične dokumentacije ali certifikatov o EU-pregledu tipa se opravi najmanj vsakih pet let.
changes to the requirements, to components of the device or to the scientific or regulatory environment,
Priglašeni organ ima vzpostavljene dokumentirane postopke za podaljšanje veljavnosti certifikatov EU o oceni tehnične dokumentacije in certifikatov o EU-pregledu tipa, s temi postopki pa se od zadevnega proizvajalca zahteva, da predloži povzetek sprememb in znanstvenih ugotovitev o pripomočku, vključno z:
changes to applied or new harmonised standards, CS or equivalent documents, and
vsemi spremembami prvotno odobrenega pripomočka, vključno s spremembami, ki še niso bile priglašene,
changes in medical, scientific and technical knowledge, such as:
izkušnjami, pridobljenimi z nadzorom po dajanju na trg,
new treatments,
izkušnjami z upravljanjem tveganja,
changes in test methods,
izkušnjami s posodabljanjem dokazovanja skladnosti s splošnimi zahtevami glede varnosti in učinkovitosti iz Priloge I,
new scientific findings on materials and components, including findings on their biocompatibility,
izkušnjami s pregledi klinične ocene, vključno z rezultati vseh kliničnih raziskav in kliničnega spremljanja po dajanju na trg,
experience from studies on comparable devices,
spremembami zahtev, sestavnih delov pripomočka ali znanstvenega ali regulativnega okolja,
data from registers and registries,
spremembami veljavnih ali novih harmoniziranih standardov, skupnih specifikacij ali enakovrednih dokumentov ter
experience from clinical investigations with comparable devices.
spremembami medicinskega, znanstvenega in tehničnega znanja, kot so:
The notified body shall have documented procedures to assess the information referred to in the second paragraph and shall pay particular attention to clinical data from post-market surveillance and PMCF activities undertaken since the previous certification or re-certification, including appropriate updates to manufacturers' clinical evaluation reports.
nove terapije,
For the decision on re-certification, the notified body in question shall use the same methods and principles as for the initial certification decision.
spremembe preskusnih metod,
If necessary, separate forms shall be established for re-certification taking into account the steps taken for certification such as application and application review.
nove znanstvene ugotovitve v zvezi z materiali in sestavinami, vključno z ugotovitvami o njihovi biokompatibilnosti,
ANNEX VIII
izkušnje, pridobljene s študijami o primerljivih pripomočkih,
CLASSIFICATION RULES
podatki iz registrov in podatkovnih zbirk,
DEFINITIONS SPECIFIC TO CLASSIFICATION RULES
izkušnje, pridobljene s kliničnimi raziskavami s primerljivimi pripomočki.
DURATION OF USE
Priglašeni organ ima vzpostavljene dokumentirane postopke za ocenjevanje informacij iz drugega odstavka in posebno pozornost namenijo kliničnim podatkom, pridobljenim z nadzorom po dajanju na trg in z dejavnostmi kliničnega spremljanja po dajanju na trg, ki so bile izvedene od prejšnjega certificiranja ali ponovnega certificiranja, vključno z ustreznimi posodobitvami poročil proizvajalcev o klinični oceni.
‘Transient’ means normally intended for continuous use for less than 60 minutes.
Zadevni priglašeni organ za odločitev o ponovnem certificiranju uporabi enake metode in načela kot za prvotno odločitev o certificiranju.
‘Short term’ means normally intended for continuous use for between 60 minutes and 30 days.
Če je potrebno, se za ponovno certificiranje pripravijo ločeni obrazci, ob upoštevanju uporabljenih ukrepov za certificiranje, kot sta vloga in pregled vloge.
‘Long term’ means normally intended for continuous use for more than 30 days.
PRILOGA VIII
INVASIVE AND ACTIVE DEVICES
PRAVILA ZA RAZVRŠČANJE
‘Body orifice’ means any natural opening in the body, as well as the external surface of the eyeball, or any permanent artificial opening, such as a stoma.
OPREDELITVE POJMOV ZA PRAVILA ZA RAZVRŠČANJE
‘Surgically invasive device’ means:
TRAJANJE UPORABE
an invasive device which penetrates inside the body through the surface of the body, including through mucous membranes of body orifices with the aid or in the context of a surgical operation; and
„Prehodno“ pomeni običajno namenjeno neprekinjeni uporabi za manj kot 60 minut.
a device which produces penetration other than through a body orifice.
„Kratkoročno“ pomeni običajno namenjeno neprekinjeni uporabi od 60 minut do 30 dni.
‘Reusable surgical instrument’ means an instrument intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection to an active device and which is intended by the manufacturer to be reused after appropriate procedures such as cleaning, disinfection and sterilisation have been carried out.
„Dolgoročno“ pomeni običajno namenjeno neprekinjeni uporabi za več kot 30 dni.
‘Active therapeutic device’ means any active device used, whether alone or in combination with other devices, to support, modify, replace or restore biological functions or structures with a view to treatment or alleviation of an illness, injury or disability.
INVAZIVNI IN AKTIVNI PRIPOMOČKI
‘Active device intended for diagnosis and monitoring’ means any active device used, whether alone or in combination with other devices, to supply information for detecting, diagnosing, monitoring or treating physiological conditions, states of health, illnesses or congenital deformities.
„Telesna odprtina“ pomeni vsako naravno odprtino na telesu in zunanjo površino zrkla ali vsako trajno umetno odprtino, npr. stomo.
‘Central circulatory system’ means the following blood vessels: arteriae pulmonales, aorta ascendens, arcus aortae, aorta descendens to the bifurcatio aortae, arteriae coronariae, arteria carotis communis, arteria carotis externa, arteria carotis interna, arteriae cerebrales, truncus brachiocephalicus, venae cordis, venae pulmonales, vena cava superior and vena cava inferior.
„Kirurško invazivni pripomoček“ pomeni:
‘Central nervous system’ means the brain, meninges and spinal cord.
invazivni pripomoček, ki prodira v notranjost telesa skozi površino telesa, tudi prek sluznice telesnih odprtin, s pomočjo ali v okviru kirurškega posega, in
‘Injured skin or mucous membrane’ means an area of skin or a mucous membrane presenting a pathological change or change following disease or a wound.
pripomoček, ki prodira v telo drugače kot skozi obstoječo telesno odprtino.
IMPLEMENTING RULES
„Kirurški instrument za ponovno uporabo“ pomeni instrument, ki je namenjen kirurški uporabi za rezanje, vrtanje, žaganje, praskanje, strganje, spenjanje, raztegovanje, stiskanje ali podobne postopke, ne da bi bil priključen na aktivni pripomoček, in za katerega je proizvajalec predvidel ponovno uporabo po ustreznih postopkih, npr. čiščenja, razkuževanja in sterilizacije.
Application of the classification rules shall be governed by the intended purpose of the devices.
„Aktivni terapevtski pripomoček“ pomeni vsak aktivni pripomoček, ki se uporablja bodisi sam bodisi v kombinaciji z drugimi pripomočki za podpiranje, spreminjanje, nadomeščanje ali obnavljanje bioloških funkcij ali struktur z namenom zdravljenja ali lajšanja bolezni, poškodbe ali invalidnosti.
If the device in question is intended to be used in combination with another device, the classification rules shall apply separately to each of the devices.
„Aktivni pripomoček za diagnozo in spremljanje“ pomeni vsak aktivni pripomoček, ki se uporablja bodisi sam bodisi v kombinaciji z drugimi pripomočki za pridobivanje informacij za odkrivanje, diagnosticiranje, spremljanje ali zdravljenje fizioloških stanj, zdravstvenih stanj, bolezni ali prirojenih deformacij.
Accessories for a medical device and for a product listed in Annex XVI shall be classified in their own right separately from the device with which they are used.
„Centralni krvožilni sistem“ pomeni naslednje krvne žile: arteriae pulmonales, aorta ascendens, arcus aortae, aorta descendens do bifurcatio aortae, arteriae coronariae, arteria carotis communis, arteria carotis externa, arteria carotis interna, arteriae cerebrales, truncus brachiocephalicus, venae cordis, venae pulmonales, vena cava superior in vena cava inferior.
Software, which drives a device or influences the use of a device, shall fall within the same class as the device.
„Centralni živčni sistem“ pomeni možgane, možgansko ovojnico in hrbtenjačo.
If the software is independent of any other device, it shall be classified in its own right.
„Poškodovana koža ali sluznica“ pomeni površino kože ali sluznice s patološko spremembo ali spremembo, ki je posledica bolezni ali rane.
If the device is not intended to be used solely or principally in a specific part of the body, it shall be considered and classified on the basis of the most critical specified use.
IZVEDBENA PRAVILA
If several rules, or if, within the same rule, several sub-rules, apply to the same device based on the device's intended purpose, the strictest rule and sub-rule resulting in the higher classification shall apply.
Pravila za razvrščanje se uporabljajo glede na predviden namen pripomočkov.
In calculating the duration referred to in Section 1, continuous use shall mean:
Če je zadevni pripomoček namenjen uporabi v kombinaciji z drugim pripomočkom, se pravila za razvrščanje uporabljajo ločeno za vsak pripomoček.
the entire duration of use of the same device without regard to temporary interruption of use during a procedure or temporary removal for purposes such as cleaning or disinfection of the device.
Dodatki za medicinski pripomoček in za izdelek s seznama v Prilogi XVI se razvrščajo ločeno od pripomočka, s katerim se uporabljajo.
Whether the interruption of use or the removal is temporary shall be established in relation to the duration of the use prior to and after the period when the use is interrupted or the device removed; and
Programska oprema, ki poganja pripomoček ali vpliva na uporabo pripomočka, spada v isti razred kot pripomoček.
the accumulated use of a device that is intended by the manufacturer to be replaced immediately with another of the same type.
Če je programska oprema neodvisna od katerega koli drugega pripomočka, se razvrsti ločeno.
A device is considered to allow direct diagnosis when it provides the diagnosis of the disease or condition in question by itself or when it provides decisive information for the diagnosis.
Če pripomoček ni namenjen uporabi izključno ali predvsem v posameznem delu telesa, se obravnava in razvršča glede na navedeno uporabo, ki predstavlja največje tveganje.
NON-INVASIVE DEVICES
Če se več pravil ali več podpravil v istem pravilu uporablja za isti pripomoček na podlagi predvidenega namena pripomočka, se uporabi najstrožje pravilo in podpravilo, ki vodi do razvrstitve v višji razred.
Rule 1
Pri izračunu trajanja iz oddelka 1, neprekinjena uporaba pomeni:
All non-invasive devices are classified as class I, unless one of the rules set out hereinafter applies.
celotno trajanje uporabe istega pripomočka ne glede na začasno prekinitev uporabe med postopkom ali začasno odstranitvijo za namene, kot je čiščenje ali dezinfekcija pripomočka.
Rule 2
Začasnost prekinitve uporabe ali odstranitve se opredeli glede na trajanje uporabe pred obdobjem, ko je uporaba prekinjena ali pripomoček odstranjen, in po njem, in
All non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases for the purpose of eventual infusion, administration or introduction into the body are classified as class IIa:
skupno uporabo pripomočka, za katerega je proizvajalec predvidel, da se takoj nadomesti z drugim pripomočkom istega tipa.
if they may be connected to a class IIa, class IIb or class III active device; or
Šteje se, da pripomoček omogoča neposredno diagnozo, ko sam zagotovi diagnozo zadevne bolezni ali stanja ali ko zagotovi odločilne informacije za diagnozo.
if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts of organs or body cells and tissues, except for blood bags; blood bags are classified as class IIb.
NEINVAZIVNI PRIPOMOČKI
In all other cases, such devices are classified as class I.
Pravilo 1
Rule 3
Vsi neinvazivni pripomočki se razvrstijo v razred I, razen če se uporablja katero izmed pravil, navedenih v nadaljnjem besedilu.
All non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class IIb, unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class IIa.
Pravilo 2
All non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class III.
Vsi neinvazivni pripomočki, namenjeni pretakanju ali shranjevanju krvi, telesnih tekočin, celic ali tkiv, tekočin ali plinov za namene morebitne infuzije, dajanja ali vnosa v telo, se razvrstijo v razred IIa:
Rule 4
če jih je mogoče priključiti na aktivni pripomoček razreda IIa, razreda IIb ali razreda III ali
All non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
če so namenjeni pretakanju ali shranjevanju krvi ali drugih telesnih tekočin ali shranjevanju organov, delov organov ali telesnih celic in tkiv, razen vrečk za kri; vrečke za kri se razvrstijo v razred IIb.
class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates;
V vseh drugih primerih se taki pripomočki razvrstijo v razred I.
class IIb if they are intended to be used principally for injuries to skin which have breached the dermis or mucous membrane and can only heal by secondary intent;
Pravilo 3
class IIa if they are principally intended to manage the micro-environment of injured skin or mucous membrane; and
Vsi neinvazivni pripomočki, namenjeni spreminjanju biološke ali kemične sestave človeških tkiv ali celic, krvi, drugih telesnih tekočin in drugih tekočin, namenjenih za vsaditev ali doziranje v telo, se razvrstijo v razred IIb, razen če gre pri uporabi pripomočka za filtriranje, centrifugiranje ali izmenjavo plinov ali toplote; v tem primeru se razvrstijo v razred IIa.
class IIa in all other cases.
Vsi neinvazivni pripomočki, ki jih sestavlja snov ali zmes snovi in so namenjeni uporabi in vitro v neposrednem stiku s človeškimi celicami, tkivom ali organi, odvzetimi iz človeškega telesa, ali uporabi in vitro s človeškimi zarodki, preden se vsadijo ali dozirajo v telo, se razvrstijo v razred III.
This rule applies also to the invasive devices that come into contact with injured mucous membrane.
Pravilo 4
INVASIVE DEVICES
Vsi neinvazivni pripomočki, ki pridejo v stik s poškodovano kožo ali sluznico, se razvrstijo v:
Rule 5
razred I, če naj bi se uporabljali kot mehanska prepreka, za kompresijo ali vpijanje izločkov;
All invasive devices with respect to body orifices, other than surgically invasive devices, which are not intended for connection to an active device or which are intended for connection to a class I active device are classified as:
razred IIb, če naj bi se zlasti uporabljali pri poškodbah kože, pri katerih je pretrgana usnjica ali sluznica in ki se lahko zacelijo le s sekundarnim celjenjem;
class I if they are intended for transient use;
razred IIa, če naj bi se zlasti uporabljali za uravnavanje mikrookolja ranjene kože ali sluznice, in
class IIa if they are intended for short-term use, except if they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in the nasal cavity, in which case they are classified as class I; and
v razred IIa v vseh drugih primerih.
class IIb if they are intended for long-term use, except if they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in the nasal cavity and are not liable to be absorbed by the mucous membrane, in which case they are classified as class IIa.
To pravilo velja tudi za invazivne pripomočke, ki pridejo v stik s poškodovano sluznico.
All invasive devices with respect to body orifices, other than surgically invasive devices, intended for connection to a class IIa, class IIb or class III active device, are classified as class IIa.
INVAZIVNI PRIPOMOČKI
Rule 6
Pravilo 5
All surgically invasive devices intended for transient use are classified as class IIa unless they:
Vsi invazivni pripomočki, ki se uporabljajo prek telesnih odprtin ter niso kirurško invazivni pripomočki, ki niso namenjeni priključitvi na aktivne pripomočke ali so namenjeni priključitvi na aktivne pripomočke razreda I, se razvrstijo v: