natgillin/translations-raw huggingface dataset:
a detailed and adequately justified time schedule for PMCF activities (e.g. analysis of PMCF data and reporting) to be undertaken by the manufacturer.
posebne metode in postopke za PMCF, ki se uporabijo, kot je ocenjevanje ustreznih registrov ali študij PMCF;
The manufacturer shall analyse the findings of the PMCF and document the results in a PMCF evaluation report that shall be part of the clinical evaluation report and the technical documentation.
utemeljitev za ustreznost metod in postopkov iz točk (a) in (b);
The conclusions of the PMCF evaluation report shall be taken into account for the clinical evaluation referred to in Article 61 and Part A of this Annex and in the risk management referred to in Section 3 of Annex I. If, through the PMCF, the need for preventive and/or corrective measures has been identified, the manufacturer shall implement them.
sklicevanje na ustrezne dele poročila o klinični oceni iz oddelka 4 in na obvladovanje tveganja iz oddelka 3 Priloge I;
ANNEX XV
posebne cilje, ki se obravnavajo v okviru PMCF;
CLINICAL INVESTIGATIONS
oceno kliničnih podatkov v zvezi z enakovrednimi ali podobnimi pripomočki;
Ethical principles
sklicevanje na ustrezne skupne specifikacije, harmonizirane standarde, če jih proizvajalec uporablja, in ustrezne smernice o PMCF ter
Each step in the clinical investigation, from the initial consideration of the need for and justification of the study to the publication of the results, shall be carried out in accordance with recognised ethical principles.
podroben in ustrezno utemeljen časovni načrt za dejavnosti PMCF (npr. analizo podatkov PMCF in poročanje), ki jih opravi proizvajalec.
Methods
Proizvajalec analizira ugotovitve PMCF in dokumentira rezultate v poročilu o ocenjevanju PMCF, ki je del poročila o klinični oceni in tehnične dokumentacije.
Clinical investigations shall be performed on the basis of an appropriate plan of investigation reflecting the latest scientific and technical knowledge and defined in such a way as to confirm or refute the manufacturer's claims regarding the safety, performance and aspects relating to benefit-risk of devices as referred to in Article 62(1); the clinical investigations shall include an adequate number of observations to guarantee the scientific validity of the conclusions.
Ugotovitve poročila o ocenjevanju PMCF se upoštevajo pri klinični oceni iz člena 61 in dela A te priloge in pri obvladovanju tveganja iz oddelka 3 Priloge I. Če se v okviru PMCF ugotovi potreba po preventivnih in/ali korektivnih ukrepih, proizvajalec te ukrepe izvede.
The rationale for the design and chosen statistical methodology shall be presented as further described in Section 3.6 of Chapter II of this Annex.
PRILOGA XV
The procedures used to perform the clinical investigation shall be appropriate to the device under investigation.
KLINIČNE RAZISKAVE
The research methodologies used to perform the clinical investigation shall be appropriate to the device under investigation.
Etična načela
Clinical investigations shall be performed in accordance with the clinical investigation plan by a sufficient number of intended users and in a clinical environment that is representative of the intended normal conditions of use of the device in the target patient population.
Vsaka faza klinične raziskave, od začetne obravnave potrebe po študiji in utemeljitve njene upravičenosti, do objave rezultatov, se izvaja v skladu s priznanimi etičnimi načeli.
Clinical investigations shall be in line with the clinical evaluation plan as referred to in Part A of Annex XIV.
Metode
All the appropriate technical and functional features of the device, in particular those involving safety and performance, and their expected clinical outcomes shall be appropriately addressed in the investigational design.
Klinične raziskave se izvajajo na podlagi ustreznega načrta raziskav, v katerem je upoštevano najnovejše znanstveno in tehnično znanje, in v skladu s členom 62(1) potrjujejo ali zavračajo trditve proizvajalca glede varnosti, učinkovitosti in vidike, povezane s koristmi in tveganji pripomočkov; klinične raziskave vključujejo zadostno število opazovanj, da bi imele ugotovitve znanstveno veljavnost.
A list of the technical and functional features of the device and the related expected clinical outcomes shall be provided.
Predloži se utemeljitev zasnove in izbrane statistične metodologije, kot je podrobneje opisano v oddelku 3.6 poglavja II te priloge.
The endpoints of the clinical investigation shall address the intended purpose, clinical benefits, performance and safety of the device.
Postopki za izvedbo kliničnih raziskav so primerni raziskovanemu pripomočku.
The endpoints shall be determined and assessed using scientifically valid methodologies.
Raziskovalne metodologije za izvedbo kliničnih raziskav so primerne raziskovanemu pripomočku.
The primary endpoint shall be appropriate to the device and clinically relevant.
Klinične raziskave se izvajajo v skladu z načrtom klinične raziskave z zadostnim številom predvidenih uporabnikov in v kliničnem okolju, reprezentativnim za predvidene običajne okoliščine uporabe pripomočka na ciljni populaciji pacientov.
Investigators shall have access to the technical and clinical data regarding the device.
Klinične raziskave so skladne z načrtom klinične ocene iz dela A Priloge XIV.
Personnel involved in the conduct of an investigation shall be adequately instructed and trained in the proper use of the investigational device, and as regards the clinical investigation plan and good clinical practice.
V raziskovalni zasnovi so primerno obravnavane vse ustrezne tehnične in funkcionalne značilnosti pripomočka, zlasti v zvezi z varnostjo in učinkovitostjo, ter njihovi pričakovani klinični rezultati.
This training shall be verified and where necessary arranged by the sponsor and documented appropriately.
Predloži se seznam tehničnih in funkcionalnih značilnosti pripomočka in z njim povezanih pričakovanih kliničnih rezultatov.
The clinical investigation report, signed by the investigator, shall contain a critical evaluation of all the data collected during the clinical investigation, and shall include any negative findings.
Končne točke klinične raziskave se nanašajo na predvideni namen, klinične koristi, učinkovitost in varnost pripomočka.
DOCUMENTATION REGARDING THE APPLICATION FOR CLINICAL INVESTIGATION
Končne točke se določijo in ocenijo z uporabo znanstveno veljavnih metodologij.
For investigational devices covered by Article 62, the sponsor shall draw up and submit the application in accordance with Article 70 accompanied by the following documents:
Primarna končna točka je ustrezna pripomočku in je klinično relevantna.
Application form
Raziskovalci imajo dostop do tehničnih in kliničnih podatkov o pripomočku.
The application form shall be duly filled in, containing information regarding:
Osebje, ki je vključeno v potek raziskave, je ustrezno poučeno in usposobljeno za pravilno uporabo pripomočka, ki je predmet raziskave, ter v zvezi z načrtom klinične raziskave in dobro klinično prakso.
name, address and contact details of the sponsor and, if applicable, name, address and contact details of its contact person or legal representative in accordance with Article 62(2) established in the Union;
Sponzor to usposabljanje preverja in po potrebi organizira ter ustrezno dokumentira.
if different from those in Section 1.1, name, address and contact details of the manufacturer of the device intended for clinical investigation and, if applicable, of its authorised representative;
Poročilo o klinični raziskavi, ki ga podpiše raziskovalec, vključuje kritično oceno vseh podatkov, zbranih med klinično raziskavo, ter morebitne negativne ugotovitve.
title of the clinical investigation;
DOKUMENTACIJA V ZVEZI Z VLOGO ZA KLINIČNO RAZISKAVO
status of the clinical investigation application (i.e. first submission, resubmission, significant amendment);
Za pripomočke, ki so predmet raziskave, iz člena 62 sponzor v skladu s členom 70 pripravi in vloži vlogo, ki so ji priloženi naslednji dokumenti:
details and/or reference to the clinical evaluation plan;
Obrazec za vlogo
If the application is a resubmission with regard to a device for which an application has been already submitted, the date or dates and reference number or numbers of the earlier application or in the case of significant amendment, reference to the original application.
Obrazec za vlogo se ustrezno izpolni z naslednjimi informacijami:
The sponsor shall identify all of the changes from the previous application together with a rationale for those changes, in particular, whether any changes have been made to address conclusions of previous competent authority or ethics committee reviews;
ime, naslov in kontaktni podatki sponzorja in, kjer je ustrezno, ime, naslov in kontaktni podatki njegove kontaktne osebe ali pravnega zastopnika v skladu s členom 62(2) s sedežem v Uniji;
if the application is submitted in parallel with an application for a clinical trial in accordance with Regulation (EU) No 536/2014, reference to the official registration number of the clinical trial;
če se razlikujejo od tistih iz oddelka 1.1, ime, naslov in kontaktni podatki proizvajalca pripomočka za klinične raziskave in, kjer je ustrezno, njegovega pooblaščenega predstavnika;
identification of the Member States and third countries in which the clinical investigation is to be conducted as part of a multicentre or multinational study at the time of application;
naziv klinične raziskave;
a brief description of the investigational device, its classification and other information necessary for the identification of the device and device type;
status vloge za klinično raziskavo (npr. prva predložitev, ponovna predložitev, bistvena sprememba);
information as to whether the device incorporates a medicinal substance, including a human blood or plasma derivative or whether it is manufactured utilising non-viable tissues or cells of human or animal origin, or their derivatives;
podrobnosti in/ali sklicevanje na načrt klinične ocene;
summary of the clinical investigation plan including the objective or objectives of the clinical investigation, the number and gender of subjects, criteria for subject selection, whether there are subjects under 18 years of age, design of the investigation such as controlled and/or randomised studies, planned dates of commencement and of completion of the clinical investigation;
če je vloga kot ponovna predložitev v zvezi s pripomočkom, za katerega je bila vloga že vložena, datum ali datumi in referenčna številka oziroma številke prejšnje vloge, v primeru bistvene spremembe pa sklicevanje na prvotno vlogo.
if applicable, information regarding a comparator device, its classification and other information necessary for the identification of the comparator device;
Sponzor opredeli vse spremembe v primerjavi s predhodno vlogo ter razloge za te spremembe, zlasti, ali je prišlo do kakršnih koli sprememb pri obravnavanju ugotovitev pristojnega organa ali odbora za etiko iz prejšnjih pregledov;
evidence from the sponsor that the clinical investigator and the investigational site are capable of conducting the clinical investigation in accordance with the clinical investigation plan;
če se ta vloga in vloga za klinično preskušanje v skladu z Uredbo (EU) št. 536/2014 vložita skupaj, sklicevanje na uradno registracijsko številko kliničnega preskušanja;
details of the anticipated start date and duration of the investigation;
določitev držav članic in tretjih držav, v katerih se klinična raziskava izvaja kot del multicentrične ali večnacionalne študije v času predložitve vloge;
details to identify the notified body, if already involved at the stage of application for a clinical investigation;
kratek opis pripomočka, ki je predmet raziskave, njegova razvrstitev in druge informacije, ki omogočajo identifikacijo pripomočka in vrste pripomočka;
confirmation that the sponsor is aware that the competent authority may contact the ethics committee that is assessing or has assessed the application; and
informacije, ali pripomoček vsebuje zdravilo, vključno z derivati človeške krvi ali plazme, ali je izdelan z uporabo neviabilnih človeških ali živalskih tkiv ali celic ali njihovih derivatov;
the statement referred to in Section 4.1.
povzetek načrta klinične raziskave, vključno s ciljem ali cilji klinične raziskave, številom in spolom udeležencev, merili za izbor udeležencev, navedbo, ali so udeleženci mlajši od 18 let, zasnovo raziskave, kot to, ali je nadzorovana in/ali naključna študija, načrtovanimi datumi začetka in zaključka klinične raziskave;
Investigator's Brochure
kjer je ustrezno, informacije o primerjalnem pripomočku in njegovi razvrstitvi ter druge informacije, ki omogočajo identifikacijo primerjalnega pripomočka;
The investigator's brochure (IB) shall contain the clinical and non-clinical information on the investigational device that is relevant for the investigation and available at the time of application.
dokazi sponzorja, da sta klinični raziskovalec in mesto izvajanja raziskave zmožna izvedbe klinične raziskave v skladu z načrtom kliničnih raziskav;
Any updates to the IB or other relevant information that is newly available shall be brought to the attention of the investigators in a timely manner.
podrobnosti o predvidenem datumu začetka in trajanju raziskave;
The IB shall be clearly identified and contain in particular the following information:
podrobnosti za identifikacijo priglašenega organa, če ta že sodeluje ob vložitvi vloge za klinično raziskavo;
Identification and description of the device, including information on the intended purpose, the risk classification and applicable classification rule pursuant to Annex VIII, design and manufacturing of the device and reference to previous and similar generations of the device.
potrditev, da je sponzor seznanjen s tem, da lahko pristojni organ stopi v stik z odborom za etiko, ki ocenjuje ali je ocenil vlogo, in
Manufacturer's instructions for installation, maintenance, maintaining hygiene standards and for use, including storage and handling requirements, as well as, to the extent that such information is available, information to be placed on the label, and instructions for use to be provided with the device when placed on the market.
izjavo iz oddelka 4.1.
In addition, information relating to any relevant training required.
Brošura raziskovalca
Pre-clinical evaluation based on relevant pre-clinical testing and experimental data, in particular regarding in-design calculations, in vitro tests, ex vivo tests, animal tests, mechanical or electrical tests, reliability tests, sterilisation validation, software verification and validation, performance tests, evaluation of biocompatibility and biological safety, as applicable.
Brošura raziskovalca vsebuje klinične in neklinične informacije o pripomočku, ki je predmet raziskave, ki so pomembne za raziskavo in so na voljo v času vložitve vloge.
Existing clinical data, in particular:
Raziskovalcem se pravočasno sporoči vsaka sprememba brošure raziskovalca ali druge pomembne nove informacije.
from relevant scientific literature available relating to the safety, performance, clinical benefits to patients, design characteristics and intended purpose of the device and/or of equivalent or similar devices;
Brošura raziskovalca je jasno opredeljena in zajema zlasti naslednje informacije:
other relevant clinical data available relating to the safety, performance, clinical benefits to patients, design characteristics and intended purpose of equivalent or similar devices of the same manufacturer, including length of time on the market and a review of performance, clinical benefit and safety-related issues and any corrective actions taken.
identifikacija in opis pripomočka, vključno z informacijami o predvidenem namenu, razvrstitvi v razred tveganja in veljavnem pravilu za razvrščanje v skladu s Prilogo VIII, zasnovi in izdelavi pripomočka, ter sklicevanje na prejšnje in podobne generacije pripomočkov;
Summary of the benefit-risk analysis and the risk management, including information regarding known or foreseeable risks, any undesirable effects, contraindications and warnings.
navodila proizvajalca za montažo, vzdrževanje, ohranjanje higienskih standardov in uporabo, vključno z zahtevami glede skladiščenja in ravnanja, ter, če so na voljo, informacije, ki se natisnejo na etiketi, in navodila za uporabo, ki se zagotovijo s pripomočkom, ko je dan na trg.
In the case of devices that incorporate a medicinal substance, including a human blood or plasma derivative or devices manufactured utilising non-viable tissues or cells of human or animal origin, or their derivatives, detailed information on the medicinal substance or on the tissues, cells or their derivatives, and on the compliance with the relevant general safety and performance requirements and the specific risk management in relation to the substance or tissues, cells or their derivatives, as well as evidence for the added value of incorporation of such constituents in relation to the clinical benefit and/or safety of the device.
Poleg tega informacije o vsakem potrebnem usposabljanju;
A list detailing the fulfilment of the relevant general safety and performance requirements set out in Annex I, including the standards and CS applied, in full or in part, as well as a description of the solutions for fulfilling the relevant general safety and performance requirements, in so far as those standards and CS have not or have only been partly fulfilled or are lacking.
predklinično oceno na podlagi relevantnih podatkov o predkliničnih preskusih in poskusih, zlasti glede projektnih izračunov, preskusov in vitro in ex vivo, preskusov na živalih, mehanskih ali električnih preskusov, preskusov zanesljivosti, potrjevanja sterilizacije, preverjanja in potrjevanja programske opreme, preskusov učinkovitosti, ocenjevanja biokompatibilnosti in biološke varnosti, kot je ustrezno;
A detailed description of the clinical procedures and diagnostic tests used in the course of the clinical investigation and in particular information on any deviation from normal clinical practice.
obstoječe klinične podatke, zlasti:
Clinical Investigation Plan
podatke iz ustrezne razpoložljive znanstvene literature glede varnosti, učinkovitosti, kliničnih koristi za paciente, značilnosti zasnove in predvidenega namena pripomočka in/ali enakovrednih ali podobnih pripomočkov;
The clinical investigation plan (CIP) shall set out the rationale, objectives, design methodology, monitoring, conduct, record-keeping and the method of analysis for the clinical investigation.
druge ustrezne razpoložljive klinične podatke glede varnosti, učinkovitosti, kliničnih koristi za paciente, značilnosti zasnove in predvidenega namena enakovrednih ali podobnih pripomočkov istega proizvajalca, vključno s časom, odkar so na voljo na trgu, in pregledom vprašanj, povezanih z učinkovitostjo, kliničnimi koristmi in varnostjo, ter morebitnimi sprejetimi korektivnimi ukrepi;
It shall contain in particular the information as laid down in this Annex.
povzetek analize razmerja med koristmi in tveganji ter obvladovanja tveganja, vključno z informacijami o znanih ali predvidljivih tveganjih, morebitnih neželenih učinkih, kontraindikacijah in opozorilih;
If part of this information is submitted in a separate document, it shall be referenced in the CIP.
v primeru pripomočkov, ki vsebujejo zdravilno učinkovino, vključno z derivatom človeške krvi ali plazme, ali pripomočkov, izdelanih z uporabo neviabilnih človeških ali živalskih tkiv ali celic, podrobne informacije o zdravilni učinkovini ali tkivih, celicah ali njihovih derivatih in skladnosti z ustreznimi splošnimi zahtevami glede varnosti in učinkovitosti ter s posebnimi ukrepi za obvladovanje tveganja v zvezi z učinkovino ali tkivi, celicami ali njihovimi derivati ter dokazilo o dodani vrednosti vključitve teh sestavin v zvezi s klinično koristjo in/ali varnostjo pripomočka;
Single identification number of the clinical investigation, as referred to in Article 70(1).
podroben seznam o doslednem ali delnem izpolnjevanju zadevnih splošnih zahtev glede varnosti in učinkovitosti iz Priloge I, vključno s standardi in skupnimi specifikacijami, ki se uporabljajo, ter opis rešitev za izpolnjevanje zadevnih splošnih zahtev glede varnosti in učinkovitosti, če ti standardi in skupne specifikacije niso bili izpolnjeni ali so bili le delno izpolnjeni ali pa ne obstajajo;
Identification of the sponsor — name, address and contact details of the sponsor and, where applicable, the name, address and contact details of the sponsor's contact person or legal representative in accordance with Article 62(2) established in the Union.
podroben opis kliničnih postopkov in diagnostičnih preskusov, uporabljenih med klinično raziskavo, in zlasti informacije o morebitnih odstopanjih od običajne klinične prakse.
Information on the principal investigator at each investigational site, the coordinating investigator for the investigation, the address details for each investigational site and the emergency contact details for the principal investigator at each site.
Načrt klinične raziskave
The roles, responsibilities and qualifications of the various kinds of investigators shall be specified in the CIP.
V načrtu klinične raziskave so navedeni utemeljitev, cilji, metodologija zasnove, spremljanje, izvajanje in vodenje evidenc ter analizna metoda za klinično raziskavo.
A brief description of how the clinical investigation is financed and a brief description of the agreement between the sponsor and the site.
Zajema zlasti v tej prilogi navedene informacije.
Overall synopsis of the clinical investigation, in an official Union language determined by the Member State concerned.
Če se del teh informacij predloži v ločenem dokumentu, se v načrtu klinične raziskave navede sklic nanj.
Identification and description of the device, including its intended purpose, its manufacturer, its traceability, the target population, materials coming into contact with the human body, the medical or surgical procedures involved in its use and the necessary training and experience for its use, background literature review, the current state of the art in clinical care in the relevant field of application and the proposed benefits of the new device.
Enotna identifikacijska številka klinične raziskave iz člena 70(1).
Risks and clinical benefits of the device to be examined, with justification of the corresponding expected clinical outcomes in the clinical investigation plan.
Identifikacija sponzorja – ime, naslov in kontaktni podatki sponzorja ter, kjer je ustrezno, ime, naslov in kontaktni podatki njegove kontaktne osebe ali pravnega zastopnika v skladu s členom 62(2) s sedežem v Uniji.
Description of the relevance of the clinical investigation in the context of the state of the art of clinical practice.
Informacije o glavnem raziskovalcu v vsakem od mest izvajanja raziskave in raziskovalcu koordinatorju za raziskavo, naslov vsakega od mest izvajanja raziskave in kontaktni podatki v nujnih primerih za glavnega raziskovalca v vsakem od mest izvajanja raziskave.
Objectives and hypotheses of the clinical investigation.
V načrtu klinične raziskave se navedejo vloge, odgovornosti in kvalifikacije posameznih vrst raziskovalcev.
Design of the clinical investigation with evidence of its scientific robustness and validity.
Kratek opis financiranja klinične raziskave in kratek opis sporazuma med sponzorjem in mestom izvajanja raziskave.
General information such as type of investigation with rationale for choosing it, for its endpoints and for its variables as set out in the clinical evaluation plan.
Splošni pregled klinične raziskave v uradnem jeziku Unije, ki ga določi zadevna država članica.
Information on the investigational device, on any comparator and on any other device or medication to be used in the clinical investigation.
Identifikacija in opis pripomočka, vključno z njegovim predvidenim namenom, proizvajalcem, sledljivostjo, ciljno populacijo, materiali, ki pridejo v stik s človeškim telesom, medicinskimi ali kirurškimi postopki, povezanimi z njegovo uporabo, ter usposabljanji in izkušnjami, potrebnimi za njegovo uporabo, pregledom temeljne literature, zadnjega stanja tehničnega razvoja na ustreznem področju uporabe in pričakovane koristi novega pripomočka.