natgillin/translations-raw huggingface dataset:
EU quality management system certificates and EU quality assurance certificates shall include the identification of the devices or groups of devices, the risk classification, and, for class IIb devices, the intended purpose.
Vsak certifikat se nanaša na samo en postopek ugotavljanja skladnosti.
The notified body shall be able to demonstrate on request, which (individual) devices are covered by the certificate.
Certifikati se izdajo samo za enega proizvajalca.
The notified body shall set up a system that enables the determination of the devices, including their classification, covered by the certificate.
Ime in naslov proizvajalca, vključena v certifikat, sta enaka kot ime in naslov, registrirana v elektronskem sistemu iz člena 30.
Certificates shall contain, if applicable, a note that, for the placing on the market of the device or devices it covers, another certificate issued in accordance with this Regulation is required.
Področje uporabe certifikatov nedvoumno identificira pripomoček ali pripomočke, na katere se certifikati nanašajo:
EU quality management system certificates and EU quality assurance certificates for class I devices for which the involvement of a notified body is required pursuant to Article 52(7) shall include a statement that the audit by the notified body of the quality management system was limited to the aspects required under that paragraph.
certifikati EU o oceni tehnične dokumentacije in certifikati o EU-pregledu tipa in certifikati EU o preverjanju izdelka vključujejo jasno identifikacijo pripomočka ali pripomočkov, vključno z imenom, modelom in tipom, ter predvideni namen, kot ga proizvajalec navaja v navodilih za uporabo in v zvezi s katerim je bil pripomoček ocenjen v postopku ugotavljanja skladnosti, razred tveganja in osnovni UDI-DI iz člena 27(6);
Where a certificate is supplemented, modified or re-issued, the new certificate shall contain a reference to the preceding certificate and its date of issue with identification of the changes.
certifikati EU o sistemu vodenja kakovost in certifikati EU za zagotavljanje kakovosti vključujejo identifikacijo pripomočka ali skupin pripomočkov, razred tveganja in za pripomočke razreda IIb tudi predvideni namen.
MINIMUM CONTENT OF THE CERTIFICATES
Priglašeni organ je na zahtevo zmožen določiti, na katere (posamezne) pripomočke se certifikat nanaša.
name, address and identification number of the notified body;
Priglašeni organ vzpostavi sistem, ki omogoča določitev pripomočkov, vključno z njihovo klasifikacijo, na katere se certifikat nanaša.
name and address of the manufacturer and, if applicable, of the authorised representative;
Certifikati po potrebi vključujejo opozorilo, da je za dajanje na trg pripomočka ali pripomočkov, na katere se ta certifikat nanaša, potreben drug certifikat, izdan v skladu s to uredbo.
unique number identifying the certificate;
Certifikati EU o sistemu vodenja kakovosti in certifikati EU za zagotavljanje kakovosti za pripomočke razreda I, pri katerih mora biti v skladu s členom 52(7) vključen priglašeni organ, vključujejo izjavo, da je presoja sistema vodenja kakovosti, ki ga opravi priglašeni organ, omejen na vidike, zahtevane po navedenem odstavku.
if already issued, the SRN of the manufacturer referred to in to Article 31(2);
Kadar se certifikat dopolni, spremeni ali ponovno izda, novi certifikat vsebuje sklic na prejšnji certifikat in datum njegove izdaje ter navedbo sprememb.
date of issue;
MINIMALNA VSEBINA CERTIFIKATOV
date of expiry;
Ime, naslov in identifikacijska številka priglašenega organa.
data needed for the unambiguous identification of the device or devices where applicable as specified in Section 4 of Part I;
Ime in naslov proizvajalca in, kjer je ustrezno, pooblaščenega predstavnika.
if applicable, reference to any previous certificate as specified in Section 8 of Chapter I;
Edinstvena identifikacijska številka certifikata.
reference to this Regulation and the relevant Annex in accordance with which the conformity assessment has been carried out;
Enotna registrska številka proizvajalca iz člena 31(2), če je že bila dodeljena.
examinations and tests performed, e.g. reference to relevant CS, harmonised standards, test reports and audit report(s);
Datum izdaje.
if applicable, reference to the relevant parts of the technical documentation or other certificates required for the placing on the market of the device or devices covered;
Datum poteka veljavnosti.
if applicable, information about the surveillance by the notified body;
Podatki, potrebni za nedvoumno identifikacijo pripomočka ali pripomočkov, kjer je ustrezno, kot je opredeljeno v oddelku 4 dela I.
conclusions of the notified body's conformity assessment with regard to the relevant Annex;
Kjer je ustrezno, sklicevanje na vsak predhodni certifikat, kot je opredeljeno v oddelku 8 poglavja I.
conditions for or limitations to the validity of the certificate;
Sklicevanje na to uredbo in zadevno prilogo, v skladu s katero je bilo opravljeno ugotavljanje skladnosti.
legally binding signature of the notified body in accordance with the applicable national law.
Opravljeni pregledi in preskusi, npr. sklicevanje na ustrezne skupne specifikacije, harmonizirane standarde, poročila o preskusih in poročilo ali poročila o presoji.
ANNEX XIII
Kjer je ustrezno, sklicevanje na ustrezne dele tehnične dokumentacije ali druge certifikate, potrebne za dajanje pripomočka ali pripomočkov, na katere se certifikati nanašajo, na trg.
PROCEDURE FOR CUSTOM-MADE DEVICES
Kjer je ustrezno, informacije o nadzoru, ki ga izvaja priglašeni organ.
For custom-made devices, the manufacturer or its authorised representative shall draw up a statement containing all of the following information:
Ugotovitve priglašenega organa, pridobljene pri ugotavljanju skladnosti v zvezi z ustrezno prilogo.
the name and address of the manufacturer, and of all manufacturing sites,
Pogoji ali omejitve veljavnosti certifikata.
if applicable, the name and address of the authorised representative,
Pravno zavezujoč podpis priglašenega organa v skladu z veljavnim nacionalnim pravom.
data allowing identification of the device in question,
PRILOGA XIII
a statement that the device is intended for exclusive use by a particular patient or user, identified by name, an acronym or a numerical code,
POSTOPEK ZA PRIPOMOČKE, IZDELANE ZA POSAMEZNEGA UPORABNIKA
the name of the person who made out the prescription and who is authorised by national law by virtue of their professional qualifications to do so, and, where applicable, the name of the health institution concerned,
Za pripomočke, izdelane za posameznega uporabnika, proizvajalec ali njegov pooblaščeni predstavnik pripravi izjavo, ki vključuje vse naslednje informacije:
the specific characteristics of the product as indicated by the prescription,
ime in naslov proizvajalca in vseh proizvodnih obratov;
a statement that the device in question conforms to the general safety and performance requirements set out in Annex I and, where applicable, indicating which general safety and performance requirements have not been fully met, together with the grounds,
kjer je ustrezno, ime in naslov pooblaščenega predstavnika;
where applicable, an indication that the device contains or incorporates a medicinal substance, including a human blood or plasma derivative, or tissues or cells of human origin, or of animal origin as referred to in Regulation (EU) No 722/2012.
podatke, ki omogočajo identifikacijo zadevnega pripomočka;
The manufacturer shall undertake to keep available for the competent national authorities documentation that indicates its manufacturing site or sites and allows an understanding to be formed of the design, manufacture and performance of the device, including the expected performance, so as to allow assessment of conformity with the requirements of this Regulation.
izjavo, da pripomoček lahko uporablja izključno določen pacient ali uporabnik, identificiran z imenom, akronimom ali številčno kodo;
The manufacturer shall take all the measures necessary to ensure that the manufacturing process produces devices which are manufactured in accordance with the documentation referred to in Section 2.
ime osebe, ki je izdala naročilnico in ki je po nacionalnem pravu zaradi svojih poklicnih kvalifikacij pristojna za izdajo naročilnice, in, kjer je ustrezno, ime zadevne zdravstvene ustanove;
The statement referred to in the introductory part of Section 1 shall be kept for a period of at least 10 years after the device has been placed on the market.
posebne značilnosti izdelka, kot so navedene v naročilnici;
In the case of implantable devices, the period shall be at least 15 years.
izjavo, da zadevni pripomoček izpolnjuje splošne zahteve glede varnosti in učinkovitosti iz Priloge I, po potrebi ob navedbi, katere splošne zahteve glede varnosti in učinkovitosti niso bile v celoti izpolnjene, skupaj z razlogi;
The manufacturer shall review and document experience gained in the post-production phase, including from PMCF as referred to in Part B of Annex XIV, and implement appropriate means to apply any necessary corrective action, In that context, it shall report in accordance with Article 87(1) to the competent authorities any serious incidents or field safety corrective actions or both as soon as it learns of them.
kjer je ustrezno, navedbo, da pripomoček vsebuje ali vgrajuje zdravilno učinkovino, vključno z derivati človeške krvi ali plazme ali človeškimi ali živalskimi tkivi ali celicami, kot so navedeni v Uredbi (EU) št. 722/2012.
ANNEX XIV
Proizvajalec se zaveže, da bo za pristojne nacionalne organe hranil dokumentacijo, v kateri je naveden njegov proizvodni obrat ali obrati in ki omogoča razumevanje zasnove, izdelave in učinkovitost pripomočka, vključno s pričakovano učinkovitostjo, tako da bo omogočeno ugotavljanje skladnosti z zahtevami iz te uredbe.
CLINICAL EVALUATION AND POST-MARKET CLINICAL FOLLOW-UP
Proizvajalec sprejme vse potrebne ukrepe za zagotovitev, da so pripomočki, nastali v postopku izdelave, izdelani v skladu z dokumentacijo iz oddelka 2.
CLINICAL EVALUATION
Izjava iz uvodnega dela oddelka 1 se hrani vsaj deset let po tem, ko je bil pripomoček dan na trg.
To plan, continuously conduct and document a clinical evaluation, manufacturers shall:
V primeru pripomočkov za vsaditev je to obdobje vsaj 15 let.
establish and update a clinical evaluation plan, which shall include at least:
Proizvajalec pregleda in dokumentira izkušnje, pridobljene v poproizvodni fazi, vključno s kliničnim spremljanjem po dajanju na trg iz dela B Priloge XIV, in uporabi ustrezna sredstva za izvedbo vseh potrebnih korektivnih ukrepov.
an identification of the general safety and performance requirements that require support from relevant clinical data;
V zvezi s tem pristojnim organom v skladu s členom 87(1) poroča o vseh resnih zapletih ali varnostnih korektivnih ukrepov ali obojem, takoj ko je o njih obveščen.
a specification of the intended purpose of the device;
PRILOGA XIV
a clear specification of intended target groups with clear indications and contra-indications;
KLINIČNA OCENA IN KLINIČNO SPREMLJANJE PO DAJANJU NA TRG
a detailed description of intended clinical benefits to patients with relevant and specified clinical outcome parameters;
KLINIČNA OCENA
a specification of methods to be used for examination of qualitative and quantitative aspects of clinical safety with clear reference to the determination of residual risks and side-effects;
Za načrtovanje, neprekinjeno izvajanje in dokumentiranje klinične ocene proizvajalci:
an indicative list and specification of parameters to be used to determine, based on the state of the art in medicine, the acceptability of the benefit-risk ratio for the various indications and for the intended purpose or purposes of the device;
oblikujejo in posodabljajo načrt klinične ocene, ki vključuje vsaj naslednje:
an indication how benefit-risk issues relating to specific components such as use of pharmaceutical, non-viable animal or human tissues, are to be addressed; and
opredelitev splošnih zahtev glede varnosti in učinkovitosti, ki se jim priložijo ustrezni klinični podatki;
a clinical development plan indicating progression from exploratory investigations, such as first-in-man studies, feasibility and pilot studies, to confirmatory investigations, such as pivotal clinical investigations, and a PMCF as referred to in Part B of this Annex with an indication of milestones and a description of potential acceptance criteria;
specifikacijo predvidenega namena pripomočka;
identify available clinical data relevant to the device and its intended purpose and any gaps in clinical evidence through a systematic scientific literature review;
jasno opredelitev predvidenih ciljnih skupin z jasno navedbo indikacij in kontraindikacij;
appraise all relevant clinical data by evaluating their suitability for establishing the safety and performance of the device;
podroben opis predvidenih kliničnih koristi za paciente ter zadevnih in jasno opredeljenih parametrov kliničnega izida;
generate, through properly designed clinical investigations in accordance with the clinical development plan, any new or additional clinical data necessary to address outstanding issues; and
specifikacijo metod, ki se uporabljajo za pregled kvalitativnih in kvantitativnih vidikov klinične varnosti z jasnim napotilom na določanje preostalega tveganja in stranskih učinkov;
analyse all relevant clinical data in order to reach conclusions about the safety and clinical performance of the device including its clinical benefits.
okvirni seznam in specifikacijo parametrov, ki se ob upoštevanju zadnjega stanja tehničnega razvoja v medicini uporabljajo za ugotavljanje sprejemljivosti razmerja med koristmi in tveganji za različne indikacije in predvideni namen ali namene pripomočka;
The clinical evaluation shall be thorough and objective, and take into account both favourable and unfavourable data.
navedbo, kako obravnavati vprašanja glede koristi in tveganj, povezanih s posameznimi sestavnimi deli, kot so uporaba farmacevtskih izdelkov, neviabilnega živalskega ali človeškega tkiva, in
Its depth and extent shall be proportionate and appropriate to the nature, classification, intended purpose and risks of the device in question, as well as to the manufacturer's claims in respect of the device.
klinični razvojni načrt, v katerem je naveden napredek od raziskovanja, kot so prvi preskusi na človeku, študije izvedljivosti in pilotne študije, do potrditvenih raziskav, kot so osrednje klinične raziskave, in klinično spremljanje po dajanju na trg iz dela B te priloge z navedbo mejnikov in opisom mogočih meril sprejemljivosti;
A clinical evaluation may be based on clinical data relating to a device for which equivalence to the device in question can be demonstrated.
s sistematičnim preučevanjem znanstvene literature identificirajo dostopne klinične podatke o pripomočku in njegovem predvidenem namenu ter morebitne vrzeli v kliničnih dokazih;
The following technical, biological and clinical characteristics shall be taken into consideration for the demonstration of equivalence:
ocenijo vse relevantne klinične podatke z ovrednotenjem njihove primernosti za določitev varnosti in učinkovitosti pripomočka;
Technical: the device is of similar design; is used under similar conditions of use; has similar specifications and properties including physicochemical properties such as intensity of energy, tensile strength, viscosity, surface characteristics, wavelength and software algorithms; uses similar deployment methods, where relevant; has similar principles of operation and critical performance requirements;
z ustrezno zasnovanimi kliničnimi raziskavami v skladu s kliničnim razvojnim načrtom ustvarjajo nove ali dodatne klinične podatke, potrebne za obravnavo nerešenih vprašanj, in
Biological: the device uses the same materials or substances in contact with the same human tissues or body fluids for a similar kind and duration of contact and similar release characteristics of substances, including degradation products and leachables;
analizirajo vse pomembne klinične podatke, na podlagi katerih je mogoče sklepati o varnosti in klinični učinkovitosti pripomočka, vključno z njegovimi kliničnimi koristmi.
Clinical: the device is used for the same clinical condition or purpose, including similar severity and stage of disease, at the same site in the body, in a similar population, including as regards age, anatomy and physiology; has the same kind of user; has similar relevant critical performance in view of the expected clinical effect for a specific intended purpose.
Klinična ocena je temeljita in objektivna ter upošteva ugodne in neugodne podatke.
The characteristics listed in the first paragraph shall be similar to the extent that there would be no clinically significant difference in the safety and clinical performance of the device.
Poglobljenost in obseg ocene sta sorazmerna in ustrezna glede na naravo, razvrstitev, predvideni namen tveganja zadevnega pripomočka ter trditve proizvajalca glede pripomočka.
Considerations of equivalence shall be based on proper scientific justification.
Klinična ocena lahko temelji na kliničnih podatkih za pripomoček, glede katerega je mogoče dokazati enakovrednost z zadevnim pripomočkom.
It shall be clearly demonstrated that manufacturers have sufficient levels of access to the data relating to devices with which they are claiming equivalence in order to justify their claims of equivalence.
Pri dokazovanju enakovrednosti se upoštevajo naslednje tehnične, biološke in klinične značilnosti:
The results of the clinical evaluation and the clinical evidence on which it is based shall be documented in a clinical evaluation report which shall support the assessment of the conformity of the device.
Tehnične: pripomoček ima podobno zasnovo; za pripomoček veljajo podobni pogoji uporabe; pripomoček ima podobne specifikacije in lastnosti, vključno s fizikalno-kemijskimi lastnostmi, kot so energijska intenzivnost, natezna trdnost, viskoznost, površinske lastnosti, valovna dolžina in programski algoritmi; za pripomoček veljajo podobne metode uporabe, kjer je to ustrezno; pripomoček ima podobna načela delovanja in zahteve glede kritične učinkovitosti.
The clinical evidence together with non-clinical data generated from non-clinical testing methods and other relevant documentation shall allow the manufacturer to demonstrate conformity with the general safety and performance requirements and shall be part of the technical documentation for the device in question.
Biološke: pripomoček uporablja iste materiale ali snovi v stiku z istimi človeškimi tkivi ali telesnimi tekočinami za podobno vrsto in trajanje stika ter podobno sproščanje snovi, vključno s produkti razgradnje in pronicanimi snovmi.
Both favourable and unfavourable data considered in the clinical evaluation shall be included in the technical documentation.
Klinične: pripomoček se uporablja za enaka klinična stanja ali namen, vključno s podobno resnostjo in stadijem bolezni, na istem mestu v telesu, pri podobni populaciji, vključno s starostjo, anatomijo in fiziologijo; pripomoček uporablja enak tip uporabnikov; pripomoček ima podobno relevantno kritično učinkovitost glede na pričakovani klinični učinek za specifični predvideni namen.
POST-MARKET CLINICAL FOLLOW-UP
Pripomoček ima tako podobne značilnosti, navedene v prvem odstavku, da ni klinično bistvene razlike v varnosti in klinični učinkovitosti pripomočka.
PMCF shall be understood to be a continuous process that updates the clinical evaluation referred to in Article 61 and Part A of this Annex and shall be addressed in the manufacturer's post-market surveillance plan.
Presojanje enakovrednosti temelji na ustreznih znanstvenih utemeljitvah.
When conducting PMCF, the manufacturer shall proactively collect and evaluate clinical data from the use in or on humans of a device which bears the CE marking and is placed on the market or put into service within its intended purpose as referred to in the relevant conformity assessment procedure, with the aim of confirming the safety and performance throughout the expected lifetime of the device, of ensuring the continued acceptability of identified risks and of detecting emerging risks on the basis of factual evidence.
Jasno mora biti dokazano, da imajo proizvajalci zadostno raven dostopa do podatkov o pripomočkih, s katerimi trdijo enakovrednost, da bi tako utemeljili trditve o enakovrednosti.
PMCF shall be performed pursuant to a documented method laid down in a PMCF plan.
Rezultati klinične ocene in klinični dokazi, na katerih ocena temelji, se dokumentirajo v poročilu o klinični oceni, ki je dokazno gradivo za oceno skladnosti pripomočka.
The PMCF plan shall specify the methods and procedures for proactively collecting and evaluating clinical data with the aim of:
Klinični dokazi in neklinični podatki, pridobljeni iz nekliničnih preskusnih metod, ter druga ustrezna dokumentacija proizvajalcu omogočajo dokazovanje skladnosti s splošnimi zahtevami glede varnosti in učinkovitosti ter so vključeni v tehnično dokumentacijo zadevnega pripomočka.
confirming the safety and performance of the device throughout its expected lifetime,
V tehnično dokumentacij se vključijo ugodni in neugodni podatki, ki so bili upoštevani pri klinični oceni.
identifying previously unknown side-effects and monitoring the identified side-effects and contraindications,
KLINIČNO SPREMLJANJE PO DAJANJU NA TRG
identifying and analysing emergent risks on the basis of factual evidence,
Klinično spremljanje po dajanju na trg (PMCF) se šteje za stalen proces za posodabljanje klinične ocene iz člena 61 in dela A te priloge ter je del načrta proizvajalca za nadzor po dajanju na trg.
ensuring the continued acceptability of the benefit-risk ratio referred to in Sections 1 and 9 of Annex I, and
V okviru PMCF proizvajalec proaktivno zbira in ocenjuje klinične podatke, pridobljene pri uporabi pripomočka z oznako CE v ali na ljudeh, ki je dan na trg ali v uporabo v skladu z njegovim predvidenim namenom, kot je opredeljen z ustreznim postopkom ugotavljanja skladnosti, da bi tako potrdil varnost in učinkovitost pripomočka med pričakovano življenjsko dobo, zagotovil stalno sprejemljivost opredeljenih tveganj ter na podlagi dejanskih dokazov odkril nastajajoča tveganja.
identifying possible systematic misuse or off-label use of the device, with a view to verifying that the intended purpose is correct.
PMCF se izvaja v skladu z dokumentirano metodo, določeno v načrtu za PMCF.
The PMCF plan shall include at least:
V načrtu za PMCF so določene metode in postopki za proaktivno zbiranje in ocenjevanje kliničnih podatkov, da se:
the general methods and procedures of the PMCF to be applied, such as gathering of clinical experience gained, feedback from users, screening of scientific literature and of other sources of clinical data;
potrdita varnost in učinkovitost pripomočka med njegovo pričakovano življenjsko dobo;
the specific methods and procedures of PMCF to be applied, such as evaluation of suitable registers or PMCF studies;
opredelijo predhodno neznani stranski učinki ter spremljajo ugotovljeni stranski učinki in kontraindikacije;
a rationale for the appropriateness of the methods and procedures referred to in points (a) and (b);
opredelijo in analizirajo nastajajoča tveganja na podlagi dejanskih dokazov;
a reference to the relevant parts of the clinical evaluation report referred to in Section 4 and to the risk management referred to in Section 3 of Annex I;
zagotovi nadaljnja sprejemljivost razmerja med tveganji in koristmi iz oddelkov 1 in 9 Priloge I ter
the specific objectives to be addressed by the PMCF;
opredeli morebitna sistematična nepravilna uporaba ali uporaba pripomočka v drug namen ter s tem preveri pravilnost predvidenega namena.
an evaluation of the clinical data relating to equivalent or similar devices;
Načrt za PMCF vključuje vsaj naslednje:
reference to any relevant CS, harmonised standards when used by the manufacturer, and relevant guidance on PMCF; and
splošne metode in postopke za PMCF, ki se uporabijo, kot so zbiranje pridobljenih kliničnih izkušenj, povratne informacije uporabnikov, pregled znanstvene literature in drugih virov kliničnih podatkov;