natgillin/translations-raw huggingface dataset:
parameters of clinical performance in accordance with point (b) of Section 9.1 of Annex I to be determined, with justification for any omission; and with the exception of studies using left-over samples the specified clinical outcomes/endpoints (primary/secondary) used with a justification and the potential implications for individual health and/or public health management decisions;
Sponsorn ska genomföra uppföljningen av de försökspersoner som deltagit i prövningen.
information on the performance study population: specifications of the subjects, selection criteria, size of performance study population, representativity of target population and, if applicable, information on vulnerable subjects involved, such as children, pregnant women, immuno-compromised or elderly subjects;
BILAGA XV
information on use of data out of left over specimens banks, genetic or tissue banks, patient or disease registries etc. with description of reliability and representativity and statistical analysis approach; assurance of relevant method for determining the true clinical status of patient specimens;
JÄMFÖRELSETABELL
monitoring plan;
Direktiv 98/79/EG
data management;
Denna förordning
decision algorithms;
Artikel 1.1
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;
Artikel 1.2
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;
Artikel 1.3
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;
Artikel 2.54 och 2.55
description of the informed consent process, including a copy of the patient information sheet and consent forms;
Artikel 1.4
procedures for safety recording and reporting, including definitions of recordable and reportable events, and procedures and timelines for reporting;
Artikel 1.5
criteria and procedures for suspension or early termination of the clinical performance study;
Artikel 5.4 och 5.5
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;
Artikel 1.6
procedures for communication of test results outside the study, including communication of test results to the performance study subjects;
Artikel 1.9
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;
Artikel 1.7
(aa) list of the technical and functional features of the device indicating those that are covered by the performance study;
Artikel 5.1
(ab) bibliography.
Artikel 5.2
If part of the information referred to in the second paragraph is submitted in a separate document, it shall be referenced in the CPSP.
Artikel 4.1
For studies using left-over samples, points (u), (x), (y) and (z) shall not apply.
Artikel 4.2
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.
Artikel 19.1 och 19.2
Clinical performance study report
Artikel 4.3
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.
Artikel 19.3
The results and conclusions shall be transparent, free of bias and clinically relevant.
Artikel 4.4
The report shall contain sufficient information to enable it to be understood by an independent party without reference to other documents.
Artikel 10.10
The report shall also include as appropriate any protocol amendments or deviations, and data exclusions with the appropriate rationale.
Artikel 4.5
OTHER PERFORMANCE STUDIES
Artikel 18.6
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.
Artikel 8.1
POST-MARKET PERFORMANCE FOLLOW-UP
Artikel 5.3
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.
Artikel 89 och 92
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.
Artikel 9.1 första stycket
PMPF shall be performed pursuant to a documented method laid down in a PMPF plan.
Artikel 48.10 första stycket
The PMPF plan shall specify the methods and procedures for proactively collecting and evaluating safety, performance and scientific data with the aim of:
Artikel 9.1 andra stycket
confirming the safety and performance of the device throughout its expected lifetime,
Artikel 48.3 andra stycket, artikel 48.7 andra stycket och artikel 48.9 andra stycket
identifying previously unknown risks or limits to performance and contra-indications,
Artikel 9.2
identifying and analysing emergent risks on the basis of factual evidence,
Artikel 48.3-48.6
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
Artikel 9.3
identifying possible systematic misuse.
Artikel 48.3-48.9
The PMPF plan shall include at least:
Artikel 9.4
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 5.6
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 9.5
a rationale for the appropriateness of the methods and procedures referred to in points (a) and (b);
Artikel 9.6
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 11.3 och 11.4
the specific objectives to be addressed by the PMPF;
Artikel 9.7
an evaluation of the performance data relating to equivalent or similar devices, and the current state of the art;
Artikel 10.7
reference to any relevant CS, harmonised standards when used by the manufacturer, and relevant guidance on PMPF, and;
Artikel 9.8
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 49.1
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 9.9
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 49.4
If PMPF is not deemed appropriate for a specific device then a justification shall be provided and documented within the performance evaluation report.
Artikel 9.10
ANNEX XIV
Artikel 51.2
INTERVENTIONAL CLINICAL PERFORMANCE STUDIES AND CERTAIN OTHER PERFORMANCE STUDIES
Artikel 9.11
DOCUMENTATION REGARDING THE APPLICATION FOR INTERVENTIONAL CLINICAL PERFORMANCE STUDIES AND OTHER PERFORMANCE STUDIES INVOLVING RISKS FOR THE SUBJECTS OF THE STUDIES
Artikel 48.12
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 9.12
Application form
Artikel 54.1
The application form shall be duly filled in, containing the following information:
Artikel 9.13
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 48.2
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 10.1 och 10.2, artikel 10.3 andra meningen och artikel 10.4
title of the performance study;
Artikel 26.3, 27 och 28
single identification number in accordance with Article 66(1);
Artikel 10.3, första meningen
status of the performance study, such as. the first submission, resubmission, significant amendment;
Artikel 11.1
details and/ or reference to the performance study plan, such as including details of the design phase of the performance study;
Artikels 82.1 och 84.2
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 11.2
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 82.10 och artikel 82.11 första stycket
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 11.3
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 84.7
brief description of the device for performance study, its classification and other information necessary for the identification of the device and device type;
Artikel 11.4
summary of the performance study plan;
Artikel 11.5
if applicable, information regarding a comparator device, its classification and other information necessary for the identification of the comparator device;
Artikel 14.1 a
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 14.1 b
details of the anticipated start date and duration of the performance study;
Artikel 47.3 och 47.6
details to identify the notified body, if already involved at the stage of application for the performance study;
Artikel 14.2
confirmation that the sponsor is aware that the competent authority may contact the ethics committee that is assessing or has assessed the application;
Artikel 14.3
the statement referred to in Section 4.1.
Artikel 15.1
Investigator's brochure
Artikel 38 och artikel 39
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 15.2
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 15.3
The IB shall be clearly identified and contain in particular the following information:
Artikel 40.2 och 40.4
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 15.4
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 15.5
In addition, information relating to any relevant training required.
Artikel 51.5
Analytical performance.
Artikel 15.6
Existing clinical data, in particular:
Artikel 51.4
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 15.7
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 34.2 och artikel 40.2
Summary of the benefit-risk analysis and the risk management, including information regarding known or foreseeable risks and warnings.
Artikel 89-92
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.
Särskilt, och utan att det påverkar andra skyldigheter enligt de övriga förfaranden som avses i punkterna 3 och 4, ska det anmälda organ som utför bedömningen av överensstämmelse, för produkter för vilka ett eller flera EU-referenslaboratorier har utsetts i enlighet med artikel 100, begära att EU:s referenslaboratorier genom laboratorietester kontrollerar produktens av tillverkaren angivna prestanda och överensstämmelse med den tillämpliga gemensamma specifikationen eller med andra lösningar som tillverkarna valt för att säkerställa en nivå som åtminstone är likvärdig i fråga om säkerhet och prestanda, enligt avsnitt 4.9 i bilaga IX och avsnitt 3 j i bilaga X.
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.
Laboratorietester som utförs av ett EU-referenslaboratorium ska särskilt inriktas på analytisk och diagnostisk sensitivitet med hjälp av bästa tillgängliga referensmaterial.
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.
Detta gäller inte prestandastudier som omfattar produkter för behandlingsvägledande diagnostik där endast överblivet provmaterial används.
Performance study plan as referred to in Sections 2 and 3 of Annex XIII.
Sådana studier ska dock anmälas till den behöriga myndigheten.
Other information
Om en sponsor har för avsikt att införa ändringar i en prestandastudie som sannolikt väsentligen kommer att påverka försökspersonernas säkerhet, hälsa eller rättigheter eller tillförlitligheten eller robustheten hos de data som genereras vid studien, ska sponsorn via det elektroniska system som avses i artikel 69 inom en vecka till den eller de berörda medlemsstater där prestandastudien utförs eller ska utföras anmäla skälen till ändringarna och ändringarnas art.
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.
Sponsorn ska i anmälan inkludera en uppdaterad version av den relevanta dokumentationen enligt bilaga XIV.
Where applicable according to national law, a copy of the opinion or opinions of the ethics committee or committees concerned.
Förfarandet i denna artikel ska fram till och med den 27 maj 2029 endast tillämpas av de medlemsstater där den kliniska prövningen ska göras och som har samtyckt till det.
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.
Efter den 27 maj 2029 ska alla medlemsstater vara skyldiga att tillämpa det förfarandet.
Proof of insurance cover or indemnification of subjects in case of injury, pursuant to Article 65 and the corresponding national law.
Den befogenhet att anta delegerade akter som avses i artiklarna 10.4, 17.4, 24.10, 51.6 och 66.8 ska ges kommissionen för en period av fem år från och med den 25 maj 2017.
Documents to be used to obtain informed consent, including the patient information sheet and the informed consent document.
Kommissionen ska utarbeta en rapport om delegeringen av befogenhet senast nio månader före utgången av perioden på fem år.
Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data, in particular:
Med avvikelse från direktiv 98/79/EG får organ för bedömning av överensstämmelse som uppfyller kraven i denna förordning utses och anmälas före den 26 maj 2022.
organisational and technical arrangements that will be implemented to avoid unauthorised access, disclosure, dissemination, alteration or loss of information and personal data processed;
De anmälda organ som utses och anmäls i enlighet med denna förordning får genomföra de förfaranden för bedömning av överensstämmelse som anges i denna förordning och utfärda intyg i enlighet med denna förordning före den 26 maj 2022.
a description of measures that will be implemented to ensure confidentiality of records and personal data of subjects;
Artiklarna 31–46 och artikel 96 ska tillämpas från och med den 26 november 2017.
a description of measures that will be implemented in case of a data security breach in order to mitigate the possible adverse effects.
De anmälda organens skyldigheter i enlighet med artiklarna 31–46 ska dock före den 26 maj 2022 endast gälla de organ som lämnar in en ansökan om utseende i enlighet med artikel 34.
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.
För produkter i klass D ska artikel 24.4 tillämpas från och med den 26 maj 2023.
OTHER OBLIGATIONS OF THE SPONSOR
För produkter i klass B och C ska artikel 24.4 tillämpas från och med 26 maj 2025.
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.
För produkter i klass A ska artikel 24.4 tillämpas från och med 26 maj 2027.
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.
Ordförande
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.
Ordförande
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.
I de fall där produkternas prestanda beror på användningen av kalibratorer och/eller kontrollmaterial, ska den metrologiska spårbarheten för de värden som anges för kalibratorer och/eller kontrollmaterial säkerställas genom lämpliga referensmätmetoder och/eller lämpliga referensmaterial av högre metrologisk ordning.
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.
I tillämpliga fall ska den metrologiska spårbarheten för de värden som anges för kalibratorer och kontrollmaterial säkerställas i förhållande till certifierade referensmaterial eller referensmätmetoder.
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.
När det är lämpligt ska de upplysningar som tillverkaren lämnar anges i form av internationellt vedertagna symboler, med hänsyn tagen till de avsedda användarna.
The sponsor shall complete the follow-up of investigation subjects.
Varje symbol eller färg som används för identifiering ska överensstämma med de harmoniserade standarderna eller gemensamma specifikationerna.
ANNEX XV
Om bruksanvisningen inte lämnas i pappersformat i enlighet med avsnitt 20.1 f, en hänvisning till var den finns (eller är tillgänglig) samt i tillämpliga fall på vilken webbplats den finns att tillgå.
CORRELATION TABLE
I förekommande fall särskilda driftsanvisningar.
Directive 98/79/EC
I den mån det är möjligt och lämpligt ska upplysningarna finnas på själva produkten och/eller om lämpligt på försäljningsförpackningen.
This Regulation
Märkningen på produkter för självtestning ska innehålla följande upplysningar:
Article 1(1)
Vilken typ av prov(er) som krävs för att utföra testet (t.ex. blod, urin eller saliv).
Article 1(2)
Om det behövs ytterligare material för att testet ska fungera korrekt.
Article 1(3)
Kontaktuppgifter för ytterligare råd och hjälp.
points (54) and (55) of Article 2
Namnet på produkter som är avsedda för självtestning ska inte återspegla något annat avsett ändamål än det som anges av tillverkaren.
Article 1(4)
Information på förpackningen som innebär att produkten förblir steril (sterilförpackningen):
Article 1(5)
Följande uppgifter ska anges på den sterila förpackningen:
Article 5(4) and (5)
En angivelse om att det rör sig om en steril förpackning.
Article 1(6)
En försäkran om att produkten är i sterilt skick.
Article 1(9)
Steriliseringsmetoden.
Article 1(7)
Tillverkarens namn och adress.
Article 5(1)
En beskrivning av produkten.
Article 5(2)
Tillverkningsmånad och tillverkningsår.
Article 4(1)
En entydig upplysning om fram till vilken tidpunkt som produkten är säker att använda, uttryckt som minst år och månad, samt om relevant, dag i den ordningsföljden.