natgillin/translations-raw huggingface dataset:
identifikation og beskrivelse af udstyret, herunder oplysninger om det erklærede formål, risikoklassificering og gældende klassificeringsregel i henhold til bilag VIII, udstyrets design og fremstilling og henvisning til tidligere og lignende generationer af udstyret
data management;
fabrikantens anvisninger vedrørende installering, vedligeholdelse, opretholdelse af hygiejnestandarder og krav til brug, herunder krav til opbevaring og håndtering, samt i det omfang sådanne oplysninger er tilgængelige, oplysninger, der anføres på mærkningen, og brugsanvisning, der skal leveres med udstyret, når det bringes i omsætning.
decision algorithms;
Desuden oplysninger om enhver relevant påkrævet uddannelse
policy regarding any amendments, including those in accordance with Article 71, to or deviations from the CPSP, with a clear prohibition of use of waivers from the CPSP;
analytisk ydeevne
accountability regarding the device, in particular control of access to the device, follow-up in relation to the device used in the clinical performance study and the return of unused, expired or malfunctioning devices;
eksisterende kliniske data, navnlig:
statement of compliance with the recognised ethical principles for medical research involving humans and the principles of good clinical practice in the field of clinical performance studies as well as with the applicable regulatory requirements;
fra relevant videnskabelig litteratur, der har været underkastet peer review, og tilgængelige konsensusudtalelser eller -holdninger fra eksperter fra relevante faglige organisationer, som vedrører udstyrets og/eller tilsvarende eller lignende udstyrs sikkerhed, ydeevne, kliniske fordele for patienter, designkarakteristika, videnskabelige validitet, kliniske ydeevne og erklærede formål
description of the informed consent process, including a copy of the patient information sheet and consent forms;
andre relevante tilgængelige kliniske data, som vedrører sikkerhed, videnskabelig validitet, klinisk ydeevne, kliniske fordele for patienter, designkarakteristika og erklæret formål for tilsvarende udstyr, herunder oplysninger om deres ligheder og forskelle i forhold til det pågældende udstyr
procedures for safety recording and reporting, including definitions of recordable and reportable events, and procedures and timelines for reporting;
resumé af analysen af forholdet mellem fordele og risici, herunder oplysninger om kendte eller forudsigelige risici og advarsler
criteria and procedures for suspension or early termination of the clinical performance study;
for udstyr, der indeholder væv, celler og stoffer af human, animalsk, eller mikrobiel oprindelse, detaljerede oplysninger om det eller de pågældende væv, celler og stoffer samt om overensstemmelse med de generelle krav til sikkerhed og ydeevne og de særlige risikostyringsforanstaltninger for dette eller disse væv, celler og stoffer
criteria and procedures for follow up of subjects following completion of a performance study, procedures for follow up of subjects in the case of suspension or early termination, procedures for follow up of subjects who have withdrawn their consent and procedures for subjects lost to follow up;
en liste, hvor det angives, at de relevante generelle krav til sikkerhed og ydeevne, der er fastsat i bilag I, herunder de anvendte standarder og fælles specifikationer, er helt eller delvis overholdt, samt en beskrivelse af de løsninger, der er anvendt til at opfylde de relevante generelle krav til sikkerhed og ydeevne, for så vidt som de pågældende standarder og fælles specifikationer ikke eller kun delvis er overholdt eller mangler
procedures for communication of test results outside the study, including communication of test results to the performance study subjects;
en detaljeret beskrivelse af de kliniske procedurer og diagnostiske prøvninger, der er brugt i løbet af undersøgelsen af ydeevne, navnlig oplysninger om enhver afvigelse fra normal klinisk praksis.
policy as regards the establishment of the clinical performance study report and publication of results in accordance with the legal requirements and the ethical principles referred to in Section 2.2;
Plan for undersøgelse af ydeevne, jf. bilag XIII, punkt 2 og 3.
(aa) list of the technical and functional features of the device indicating those that are covered by the performance study;
Andre oplysninger
(ab) bibliography.
erklæring underskrevet af den fysiske eller juridiske person, der er ansvarlig for fremstillingen af udstyr, hvis ydeevne skal undersøges, om, at det pågældende udstyr er i overensstemmelse med de generelle krav til sikkerhed og ydeevne, der er fastsat i bilag I, undtagen de aspekter, der er omfattet af undersøgelsen af klinisk ydeevne, og at der med hensyn til de pågældende aspekter er truffet alle nødvendige forholdsregler for at beskytte forsøgspersonens sundhed og sikkerhed
If part of the information referred to in the second paragraph is submitted in a separate document, it shall be referenced in the CPSP.
hvor det er relevant i henhold til national ret, en kopi af udtalelsen eller udtalelserne fra den eller de etiske komitéer.
For studies using left-over samples, points (u), (x), (y) and (z) shall not apply.
Hvis der i henhold til national ret ikke kræves udtalelse eller udtalelser fra den eller de etiske komitéer, når ansøgningen indsendes, fremsendes en kopi af udtalelsen eller udtalelserne, så snart de(n) foreligger
Where any of the elements referred to in the second paragraph are not deemed appropriate for inclusion in the CPSP due to the specific study design chosen, such as use of left-over samples versus interventional clinical performance studies, a justification shall be provided.
dokumentation for forsikringsdækning eller erstatning til forsøgspersoner i tilfælde af skader i henhold til artikel 65 og den tilsvarende nationale ret
Clinical performance study report
dokumenter, der skal anvendes for at indhente informeret samtykke, herunder patientoplysningsskemaet og det dokument, ved hvilket der er givet informeret samtykke
A clinical performance study report, signed by a medical practitioner or any other authorised person responsible, shall contain documented information on the clinical performance study protocol plan, results and conclusions of the clinical performance study, including negative findings.
beskrivelse af de foranstaltninger, der træffes for at opfylde de gældende regler om beskyttelse og fortrolighed af personoplysninger, herunder:
The results and conclusions shall be transparent, free of bias and clinically relevant.
organisatoriske og tekniske foranstaltninger, der vil blive iværksat for at forhindre uautoriseret adgang, videregivelse, udbredelse, ændring eller tab af behandlede informationer og personoplysninger
The report shall contain sufficient information to enable it to be understood by an independent party without reference to other documents.
en beskrivelse af de foranstaltninger, der vil blive iværksat for at sikre fortrolighed af registreringer og personoplysninger om forsøgspersoner
The report shall also include as appropriate any protocol amendments or deviations, and data exclusions with the appropriate rationale.
en beskrivelse af de foranstaltninger, der vil blive iværksat i tilfælde af brud på datasikkerheden for at afbøde mulige negative virkninger.
OTHER PERFORMANCE STUDIES
Alle oplysninger om den tilgængelige tekniske dokumentation, f.eks. detaljerede risikoanalyser/dokumentation om styring eller specifikke prøvningsrapporter, indsendes efter anmodning til den kompetente myndighed, der behandler en ansøgning.
By analogy, the performance study plan referred to in Section 2.3.2, and the performance study report, referred to in Section 2.3.3, shall be documented for other performance studies than clinical performance studies.
ANDRE FORPLIGTELSER, DER PÅHVILER SPONSOR
POST-MARKET PERFORMANCE FOLLOW-UP
Sponsor skal have indgået en aftale til sikring af, at enhver alvorlig uønsket hændelse eller enhver anden hændelse, der er omhandlet i artikel 76, stk. 2, indberettes rettidigt af investigator eller investigatorer til sponsor.
PMPF shall be understood to be a continuous process that updates the performance evaluation referred to in Article 56 and Part A of this Annex and shall be specifically addressed in the manufacturer's post-market surveillance plan.
Den dokumentation, der er omhandlet i dette bilag, skal opbevares i mindst 10 år, efter at den kliniske undersøgelse af ydeevne med det pågældende udstyr er afsluttet, eller, hvis udstyret efterfølgende bringes i omsætning, i mindst 10 år, efter at det sidste udstyr er bragt i omsætning.
When conducting PMPF, the manufacturer shall proactively collect and evaluate performance and relevant scientific data from the use 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, performance and scientific validity throughout the expected lifetime of the device, of ensuring the continued acceptability of the benefit-risk ratio and of detecting emerging risks on the basis of factual evidence.
Hver medlemsstat skal kræve, at den i dette bilag omhandlede dokumentation kan stilles til rådighed for de kompetente myndigheder i den periode, der er omhandlet i første afsnit, hvis sponsor eller dennes kontaktperson, der er etableret på dens område, går konkurs eller indstiller sine aktiviteter inden udgangen af denne periode.
PMPF shall be performed pursuant to a documented method laid down in a PMPF plan.
Sponsor udpeger en monitor, der er uafhængig af afprøvningsstedet, til sikring af, at undersøgelsen af klinisk ydeevne foretages i overensstemmelse med planen for undersøgelse af klinisk ydeevne, principperne for god klinisk praksis og denne forordning.
The PMPF plan shall specify the methods and procedures for proactively collecting and evaluating safety, performance and scientific data with the aim of:
Sponsor skal fuldføre opfølgningen af afprøvningens forsøgspersoner.
confirming the safety and performance of the device throughout its expected lifetime,
BILAG XV
identifying previously unknown risks or limits to performance and contra-indications,
SAMMENLIGNINGSTABEL
identifying and analysing emergent risks on the basis of factual evidence,
Direktiv 98/79/EF
ensuring the continued acceptability of the clinical evidence and of the benefit-risk ratio referred to in Sections 1 and 8 of Chapter I of Annex I, and
Denne forordning
identifying possible systematic misuse.
Artikel 1, stk. 1
The PMPF plan shall include at least:
Artikel 1, stk. 2
the general methods and procedures of the PMPF to be applied, such as gathering of clinical experience gained, feedback from users, screening of scientific literature and of other sources of performance or scientific data;
Artikel 1, stk. 3
the specific methods and procedures of PMPF to be applied, such as ring trials and other quality assurance activities, epidemiological studies, evaluation of suitable patient or disease registers, genetic databanks or post-market clinical performance studies;
Artikel 2, nr. 54) og 55)
a rationale for the appropriateness of the methods and procedures referred to in points (a) and (b);
Artikel 1, stk. 4
a reference to the relevant parts of the performance evaluation report referred to in Section 1.3 of this Annex and to the risk management referred to in Section 3 of Annex I;
Artikel 1, stk. 5
the specific objectives to be addressed by the PMPF;
Artikel 5, stk. 4 og 5
an evaluation of the performance data relating to equivalent or similar devices, and the current state of the art;
Artikel 1, stk. 6
reference to any relevant CS, harmonised standards when used by the manufacturer, and relevant guidance on PMPF, and;
Artikel 1, stk. 9
a detailed and adequately justified time schedule for PMPF activities, such as analysis of PMPF data and reporting, to be undertaken by the manufacturer.
Artikel 1, stk. 7
The manufacturer shall analyse the findings of the PMPF and document the results in a PMPF evaluation report that shall update the performance evaluation report and be part of the technical documentation.
Artikel 5, stk. 1
The conclusions of the PMPF evaluation report shall be taken into account for the performance evaluation referred to in Article 56 and Part A of this Annex and in the risk management referred to in Section 3 of Annex I. If, through the PMPF, the need for preventive and/or corrective measures has been identified, the manufacturer shall implement them.
Artikel 5, stk. 2
If PMPF is not deemed appropriate for a specific device then a justification shall be provided and documented within the performance evaluation report.
Artikel 4, stk. 1
ANNEX XIV
Artikel 4, stk. 2
INTERVENTIONAL CLINICAL PERFORMANCE STUDIES AND CERTAIN OTHER PERFORMANCE STUDIES
Artikel 19, stk. 1 og 2
DOCUMENTATION REGARDING THE APPLICATION FOR INTERVENTIONAL CLINICAL PERFORMANCE STUDIES AND OTHER PERFORMANCE STUDIES INVOLVING RISKS FOR THE SUBJECTS OF THE STUDIES
Artikel 4, stk. 3
For devices intended to be used in the context of interventional clinical performance studies or other performance studies involving risks for the subjects of the studies, the sponsor shall draw up and submit the application in accordance with Article 58 accompanied by the following documents:
Artikel 19, stk. 3
Application form
Artikel 4, stk. 4
The application form shall be duly filled in, containing the following information:
Artikel 10, stk. 10
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 58(4) established in the Union;
Artikel 4, stk. 5
if different from those in Section 1.1, name, address and contact details of the manufacturer of the device intended for performance evaluation and, if applicable, of its authorised representative;
Artikel 5, stk. 3
status of the performance study, such as. the first submission, resubmission, significant amendment;
Artikel 89 og 92
details and/ or reference to the performance study plan, such as including details of the design phase of the performance study;
Artikel 9, stk. 1, første afsnit
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.
Artikel 48, stk. 10, første afsnit
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;
Artikel 9, stk.1, andet afsnit
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;
Artikel 48, stk. 3, andet afsnit, stk. 7, andet afsnit, og stk. 9, andet afsnit
identification of the Member States and third countries in which the clinical performance study is to be conducted as part of a multicentre or multinational study at the time of application;
Artikel 9, stk. 2
brief description of the device for performance study, its classification and other information necessary for the identification of the device and device type;
Artikel 48, stk. 3-6
summary of the performance study plan;
Artikel 9, stk. 3
if applicable, information regarding a comparator device, its classification and other information necessary for the identification of the comparator device;
Artikel 48, stk. 3-9
evidence from the sponsor that the clinical investigator and the investigational site are capable of conducting the clinical performance study in accordance with the performance study plan;
Artikel 9, stk. 4
details of the anticipated start date and duration of the performance study;
Artikel 5, stk. 6
details to identify the notified body, if already involved at the stage of application for the performance study;
Artikel 9, stk. 5
confirmation that the sponsor is aware that the competent authority may contact the ethics committee that is assessing or has assessed the application;
Artikel 9, stk. 6
the statement referred to in Section 4.1.
Artikel 11, stk. 3 og 4
Investigator's brochure
Artikel 9, stk. 7
The investigator's brochure (IB) shall contain the information on the device for performance study that is relevant for the study and available at the time of application.
Artikel 10, stk. 7
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.
Artikel 9, stk. 8
The IB shall be clearly identified and contain in particular the following information:
Artikel 49, stk. 1
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.
Artikel 9, stk. 9
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 the label, and instructions for use to be provided with the device when placed on the market.
Artikel 49, stk. 4
In addition, information relating to any relevant training required.
Artikel 9, stk. 10
Analytical performance.
Artikel 51, stk. 2
Existing clinical data, in particular:
Artikel 9, stk. 11
from relevant peer-reviewed scientific literature and available consensus expert opinions or positions from relevant professional associations relating to the safety, performance, clinical benefits to patients, design characteristics, scientific validity, clinical performance and intended purpose of the device and/or of equivalent or similar devices;
Artikel 48, stk. 12
other relevant clinical data available relating to the safety, scientific validity, clinical performance, clinical benefits to patients, design characteristics and intended purpose of similar devices, including details of their similarities and differences with the device in question.
Artikel 9, stk. 12
Summary of the benefit-risk analysis and the risk management, including information regarding known or foreseeable risks and warnings.
Artikel 54, stk. 1
In the case of devices that include tissues, cells and substances of human, animal or microbial origins detailed information on the tissues, cells and substances, and on the compliance with the relevant general safety and performance requirements and the specific risk management in relation to those tissues, cells and substances.
Artikel 9, stk. 13
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.
Artikel 48, stk. 2
A detailed description of the clinical procedures and diagnostic tests used in the course of the performance study and in particular information on any deviation from normal clinical practice.
Artikel 10, stk. 1 og 2, artikel 10, stk. 3, andet punktum, og artikel 10, stk. 4
Performance study plan as referred to in Sections 2 and 3 of Annex XIII.
Artikel 26, stk. 3, og artikel 27 og 28
Other information
Artikel 10, stk. 3, første punktum
A signed statement by the natural or legal person responsible for the manufacture of the device for performance study that the device in question conforms to the general safety and performance requirements laid down in Annex I apart from the aspects covered by the clinical performance study and that, with regard to those aspects, every precaution has been taken to protect the health and safety of the subject.
Artikel 11, stk. 1
Where applicable according to national law, a copy of the opinion or opinions of the ethics committee or committees concerned.
Artikel 82, stk. 1, og artikel 84, stk. 2
Where under national law the opinion or opinions of the ethics committee or committees is not required at the time of the submission of the application, a copy of the opinion or opinions shall be submitted as soon as available.
Artikel 11, stk. 2
Proof of insurance cover or indemnification of subjects in case of injury, pursuant to Article 65 and the corresponding national law.
Artikel 82, stk. 10, og artikel 82, stk. 11, første afsnit
Documents to be used to obtain informed consent, including the patient information sheet and the informed consent document.
Artikel 11, stk. 3
Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data, in particular:
Artikel 84, stk. 7
organisational and technical arrangements that will be implemented to avoid unauthorised access, disclosure, dissemination, alteration or loss of information and personal data processed;
Artikel 11, stk. 4
a description of measures that will be implemented to ensure confidentiality of records and personal data of subjects;
Artikel 11, stk. 5
a description of measures that will be implemented in case of a data security breach in order to mitigate the possible adverse effects.
Artikel 14, stk. 1, litra a)
Full details of the available technical documentation, for example detailed risk analysis/management documentation or specific test reports shall be submitted to the competent authority reviewing an application upon request.
Artikel 14, stk. 1, litra b)
OTHER OBLIGATIONS OF THE SPONSOR
Artikel 47, stk. 3 og 6
The sponsor shall undertake to keep available for the competent national authorities any documentation necessary to provide evidence for the documentation referred to in Chapter I of this Annex.
Artikel 14, stk. 2
If the sponsor is not the natural or legal person responsible for the manufacture of the device intended for performance study, that obligation may be fulfilled by that person on behalf of the sponsor.
Artikel 14, stk. 3
The sponsor shall have an agreement in place to ensure that any serious adverse events or any other event as referred to in Article 76(2) are reported by the investigator or investigators to the sponsor in a timely manner.
Artikel 15, stk. 1
The documentation mentioned in this Annex shall be kept for a period of time of at least 10 years after the clinical performance study with the device in question has ended, or, in the event that the device is subsequently placed on the market, for at least 10 years after the last device has been placed on the market.
Artikel 38 og 39
Each Member State shall require that the documentation referred to in this Annex is kept at the disposal of the competent authorities for the period indicated in the first subparagraph in case the sponsor, or his contact person, established within its territory, goes bankrupt or ceases its activity prior to the end of this period.
Artikel 15, stk. 2
The sponsor shall appoint a monitor that is independent of the investigation site to ensure that the clinical performance study is conducted in accordance with the Clinical Performance Study Plan, the principles of good clinical practice and this Regulation.
Artikel 15, stk. 3
The sponsor shall complete the follow-up of investigation subjects.
Artikel 40, stk. 2 og 4
ANNEX XV
Artikel 15, stk. 4
CORRELATION TABLE
Artikel 15, stk. 5
Directive 98/79/EC
Artikel 51, stk. 5
This Regulation
Artikel 15, stk. 6
Article 1(1)
Artikel 51, stk. 4
Article 1(2)
Artikel 15, stk. 7
Article 1(3)
Artikel 34, stk. 2, og artikel 40, stk. 2
points (54) and (55) of Article 2
Artikel 89-92
Article 1(4)