EN 13612:2002
(Main)Performance evaluation of in vitro diagnostic medical devices
Performance evaluation of in vitro diagnostic medical devices
This European Standard applies to the performance evaluation of in vitro diagnostic medical devices (IVD MDs) including IVD MDs for self-testing. It specifies the responsibilities and general requirements for the planning, conduct, assessment and documentation of a performance evaluation study by the manufacturer. It does not apply to specific evaluation plans for certain IVD MDs or a specific use.
NOTE For a selection of publications on specific evaluation plans see Bibliography.
Where a manufacturer maintains a quality system this standard addresses the compliance with "design validation" and "design changes" as described in EN ISO 9001, EN 46001 and EN 928 especially considering the nature and use of IVD MDs.
In particular, this standard applies to IVD MDs to
- show evidence to notified bodies and national authorities by results of a performance evaluation that the IVD MD performs as claimed by the manufacturer,
- establish adequate performance evaluation data originating from appropriate studies or resulting from available literature, and to
- satisfy the requirements of a quality system for design validation.
Leistungsbewertung von In-vitro-Diagnostika
Diese Europäische Norm gilt für die Leistungsbewertung von In-vitro-Diagnostika, einschließlich solcher zur Eigenanwendung. Sie legt die Verantwortlichkeiten und allgemeinen Erfordernisse zur Planung, Durchführung, Auswertung und Dokumentation einer Leistungsbewertungsstudie durch den Hersteller fest. Spezielle Studienpläne für bestimmte In-vitro-Diagnostika oder einen speziellen Gebrauch sind nicht Gegenstand dieser Norm.
ANMERKUNG Eine Auswahl von Veröffentlichungen über spezielle Studienpläne findet sich in den Literaturhinweisen.
Unterhält ein Hersteller ein Qualitätssicherungssystem, bezieht sich diese Norm auf die Erfüllung der Festlegungen zur "Entwicklungsvalidierung" und "Designänderung" nach EN ISO 9001, EN 46001 und EN 928, wobei die letztgenannte Norm speziell In-vitro-Diagnostika behandelt.
Diese Norm gilt insbesondere für In-vitro-Diagnostika, um
¾ für benannte Stellen und nationale Behörden mit den Ergebnissen einer Leistungsbewertung den Nachweis zu erbringen, dass das In-vitro-Diagnostikum die vom Hersteller beschriebenen Anforderungen erfüllt,
¾ angemessene Angaben aus den Leistungsbewertungsstudien zu erstellen, die aus geeigneten Studien oder der verfügbaren Literatur gewonnen wurden,
¾ die Anforderungen eines Qualitätssicherungssystems zur Entwicklungsvalidierung zu erfüllen.
Evaluation des performances des dispositifs médicaux de diagnostic in vitro
La présente Norme européenne s'applique à l'évaluation des performances des dispositifs médicaux de diagnostic in vitro, y compris ceux utilisés pour l'auto-test. Elle spécifie les responsabilités et les exigences générales relatives à la planification, la conduite, l'estimation et la documentation d'une étude d'évaluation des performances par le fabricant. Elle ne s'applique pas aux plans d'évaluation spécifiques à certains dispositifs ou à un usage particulier.
NOTE Voir dans la bibliographie une sélection de publications concernant des plans d'évaluation spécifiques.
Si le fabricant applique un système qualité, la présente norme permet de satisfaire aux exigences de la « validation de la conception » et des « modifications de la conception » décrites dans l'EN ISO 9001, l'EN 46001 et l'EN 928, surtout en ce qui concerne la nature et l'utilisation des dispositifs médicaux de diagnostic in vitro.
La présente norme s'applique aux dispositifs médicaux de diagnostic in vitro et a pour objet :
¾ de démontrer aux organismes notifiés et aux autorités nationales, sur la base des résultats d'une évaluation de performances, que les performances du dispositif correspondent à celles déclarées par le fabricant ;
¾ de collecter des données adéquates pour évaluer les performances, à partir d'études appropriées ou d'une documentation disponible ; et
¾ de satisfaire aux exigences d'un système qualité concernant la validation de la conception.
Ovrednotenje diagnostičnih medicinskih pripomočkov lastnosti in vitro
General Information
Relations
Overview
EN 13612:2002 - Performance evaluation of in vitro diagnostic medical devices (IVD MDs) is a CEN European Standard that defines how manufacturers should plan, conduct, assess and document performance evaluation studies. It covers IVD MDs including devices for self‑testing and is intended to generate evidence that an IVD performs as the manufacturer claims. The standard supports compliance with Directive 98/79/EC and forms part of the technical documentation used in conformity assessment and regulatory submissions.
Key topics and requirements
- Scope and purpose: Applies to performance evaluation studies used to verify performance claims (analytical/diagnostic) and to satisfy design validation requirements within a quality system.
- Responsibilities: Manufacturer retains overall responsibility and must appoint a co‑ordinator who ensures adequate resources, site competence and ethical review. Investigators at each site are named and accountable.
- Preconditions: Confirm controlled production, release quality, availability of sufficient devices and legal/ethical compliance before starting a study.
- Evaluation plan: A documented plan specifying purpose, scope, timetable, sites, minimum number of probands (for invasive sampling), instructions for use, performance claims to be validated, and record formats.
- Experimental design: Documented procedures for validating each claimed performance characteristic; includes specimen types, stability, inclusion of interferences, reference methods, calibration/traceability, controls, and limits of use. Special attention for self‑testing to ensure lay‑user conditions are simulated and instructions for use are understandable.
- Study conduct and records: Performance study records must be identifiable, complete and included in the device’s technical file. Observations, drop‑outs, outliers and unexpected outcomes must be recorded and addressed.
- Final assessment: Co‑ordinator must assess which claims are met or not, recommend corrective actions, and ensure management reviews results before issuing a declaration of conformity.
- Safety and ethics: Protection of probands and confidentiality of data are required.
Applications and who uses the standard
- Manufacturers of IVD MDs (including self‑tests) use EN 13612:2002 to design and document performance evaluation studies and to compile technical documentation for conformity assessment.
- Regulatory and quality assurance teams rely on the standard to meet Directive 98/79/EC evidence requirements.
- Notified bodies and national authorities use the outputs (evaluation plans, reports, records) to verify manufacturer claims.
- Clinical investigators and CROs follow the guidance when conducting performance studies under manufacturer oversight.
Related standards (if applicable)
- EN ISO 9001 (design validation aspects)
- EN 46001 and EN 928 (quality system and design change considerations)
- Directive 98/79/EC (IVD regulatory requirements)
- Common Technical Specifications (CTSs) where relevant
Keywords: EN 13612:2002, performance evaluation, in vitro diagnostic medical devices, IVD MDs, self‑testing, evaluation plan, performance claims, validation, Directive 98/79/EC.
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Performance evaluation of in vitro diagnostic medical devicesLWUREvaluation des performances des dispositifs médicaux de diagnostic in vitroLeistungsbewertung von In-vitro-DiagnostikaTa slovenski standard je istoveten z:EN 13612:2002SIST EN 13612:2002en11.100.10In vitro diagnostic test systemsICS:SLOVENSKI
STANDARDSIST EN 13612:200201-november-2002
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 13612March 2002ICS 11.100English versionPerformance evaluation of in vitro diagnostic medical devicesDétermination des performances des dispositifs médicauxpour diagnostic in vitroLeistungsbewertung von In-vitro-DiagnostikaThis European Standard was approved by CEN on 5 January 2002.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the Management Centre or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2002 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 13612:2002 E
Scope.52
Terms and definitions.53
General requirements for the performance evaluation.63.1
Responsibilities and resources.63.2
Documentation.73.3
Final assessment and review.74
Organisation of a performance evaluation study.74.1
Preconditions.74.2
Evaluation plan.74.3
Sites and resources.84.4
Basic design information.84.5
Experimental design.94.6
Performance study records.94.7
Observations and unexpected outcomes.104.8
Evaluation report.105
Modifications during the performance evaluation study.106
Re-evaluation.107
Protection and safety of probands.11Annex ZA (informative)
Clauses of this European Standard addressing essential requirementsor other provisions of EU Directives.12Bibliography.13
ScopeThis European Standard applies to the performance evaluation of in vitro diagnostic medical devices(IVD MDs) including IVD MDs for self-testing. It specifies the responsibilities and general requirementsfor the planning, conduct, assessment and documentation of a performance evaluation study by themanufacturer. It does not apply to specific evaluation plans for certain IVD MDs or a specific use.NOTEFor a selection of publications on specific evaluation plans see Bibliography.Where a manufacturer maintains a quality system this standard addresses the compliance with"design validation" and "design changes" as described in EN ISO 9001, EN 46001 and EN 928especially considering the nature and use of IVD MDs.In particular, this standard applies to IVD MDs to- show evidence to notified bodies and national authorities by results of a performance evaluation thatthe IVD MD performs as claimed by the manufacturer,- establish adequate performance evaluation data originating from appropriate studies or resultingfrom available literature, and to- satisfy the requirements of a quality system for design validation.2
Terms and definitionsFor the purposes of this European Standard, the following terms and definitions apply.2.1co-ordinator of a performance evaluation studyperson empowered by the manufacturer with responsibility for the entire performance evaluation studyof an in vitro diagnostic medical device2.2drop outspecimen or proband that had been selected for a performance evaluation study, but cannot beinvestigated as planned2.3evaluation plandescription of a planned performance evaluation study2.4evaluation reportdescription of and conclusions from a performance evaluation study2.5investigatorperson responsible for the execution of the performance evaluation at a certain location2.6lay personindividual who does not have specific medical education[EN ISO 9000:2000, 3.8.5]
The term “validated” is used to designate the corresponding status.NOTE 2
The use conditions for validation can be real or simulated.[ISO 9000, 3.8.5]3
General requirements for the performance evaluation3.1
Responsibilities and resourcesThe manufacturer takes the responsibility for the initiation and/or the conduct of a performanceevaluation study. He shall define the responsibility and the interrelation of all personnel who manageand conduct the performance evaluation of IVD MDs, particularly for personnel who need theorganisational freedom and authority to
DocumentationThe documentation of the performance evaluation study shall contain the files relating to clauses 3 to7 of this standard and shall be part of the technical documentation of the IVD MD.3.3
Final assessment and reviewThe co-ordinator shall assess and document which performance claims are met, state whether claimsare not met and give recommendations for corrective actions, where necessary.The responsible management of the manufacturer shall make sure that the results of the performanceevaluation study and the recommendations for corrective actions are carefully considered and properlydocumented before issuing a declaration of conformity.4
Organisation of a performance evaluation study4.1
PreconditionsBefore starting a performance evaluation study it shall be ensured by the co-ordinator thata) the performance claims of the IVD MD which are the subject of the study are specified;b) the IVD MD has been manufactured under controlled production processes and conditions;c) the IVD MD to be evaluated meets the quality control release specifications;d) a sufficient number of samples of the IVD MD can be provided during the entire period of theperformance evaluation study;e) all legal requirements for performance evaluation studies are met;f) the investigator(s) is (are) adequately skilled and trained to conduct the study and the necessaryresources are available.4.2
Evaluation planThe evaluation plan shall state the purpose on scientific, technical or medical grounds, the scope ofthe evaluation, the structure and organization of the study and the number of devices concerned.Defining the objective of the study, the co-ordinator shall have assessed which performance claimsare already verified by data or scientific literature.
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Frequently Asked Questions
EN 13612:2002 is a standard published by the European Committee for Standardization (CEN). Its full title is "Performance evaluation of in vitro diagnostic medical devices". This standard covers: This European Standard applies to the performance evaluation of in vitro diagnostic medical devices (IVD MDs) including IVD MDs for self-testing. It specifies the responsibilities and general requirements for the planning, conduct, assessment and documentation of a performance evaluation study by the manufacturer. It does not apply to specific evaluation plans for certain IVD MDs or a specific use. NOTE For a selection of publications on specific evaluation plans see Bibliography. Where a manufacturer maintains a quality system this standard addresses the compliance with "design validation" and "design changes" as described in EN ISO 9001, EN 46001 and EN 928 especially considering the nature and use of IVD MDs. In particular, this standard applies to IVD MDs to - show evidence to notified bodies and national authorities by results of a performance evaluation that the IVD MD performs as claimed by the manufacturer, - establish adequate performance evaluation data originating from appropriate studies or resulting from available literature, and to - satisfy the requirements of a quality system for design validation.
This European Standard applies to the performance evaluation of in vitro diagnostic medical devices (IVD MDs) including IVD MDs for self-testing. It specifies the responsibilities and general requirements for the planning, conduct, assessment and documentation of a performance evaluation study by the manufacturer. It does not apply to specific evaluation plans for certain IVD MDs or a specific use. NOTE For a selection of publications on specific evaluation plans see Bibliography. Where a manufacturer maintains a quality system this standard addresses the compliance with "design validation" and "design changes" as described in EN ISO 9001, EN 46001 and EN 928 especially considering the nature and use of IVD MDs. In particular, this standard applies to IVD MDs to - show evidence to notified bodies and national authorities by results of a performance evaluation that the IVD MD performs as claimed by the manufacturer, - establish adequate performance evaluation data originating from appropriate studies or resulting from available literature, and to - satisfy the requirements of a quality system for design validation.
EN 13612:2002 is classified under the following ICS (International Classification for Standards) categories: 11.100 - Laboratory medicine. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 13612:2002 has the following relationships with other standards: It is inter standard links to EN 13612:2002/AC:2002. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 13612:2002 is associated with the following European legislation: EU Directives/Regulations: 98/79/EC; Standardization Mandates: M/252. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
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SIST EN 13612:2002は、体外診断用医療機器（IVD MD）の性能評価に特化した欧州標準です。その適用範囲には、IVD MDの自己検査用機器も含まれます。この標準は、製造者が性能評価研究を計画、実施、評価、文書化する際の責任や一般要件を明確に定義しています。特定のIVD MDや特定用途に対する評価計画に関しては適用されない点も重要です。 この標準の強みは、IVD MDの性能を検証するための具体的な枠組みを提供する点にあります。製造者は、性能評価の結果を通じて、IVD MDが主張する通りに機能することを認証機関や国家当局に示すことが求められます。また、適切な研究から得られた十分な性能評価データを確立することが強調されており、利用可能な文献を活用することも含まれています。 さらに、SIST EN 13612:2002は、製造者が維持する品質システムにおける「設計の検証」や「設計変更」の遵守にも関連しています。これにより、IVD MDの特性や使用に十分に配慮した上での規制遵守が促進されます。このように、本標準はIVD MDに関する品質管理の重要な要素を包含しており、設計の妥当性を確保するための基盤となります。 この標準は、体外診断用医療機器の市場での信頼性と透明性を高めるために不可欠であり、製造者が必要とするパフォーマンス評価の基準を明示しています。これにより、IVD MDに対する規制要件を満たしつつ、高品質な製品の提供を可能にするための重要な文書です。
표준 EN 13612:2002는 체외 진단 의료기기(IVD MDs)의 성능 평가에 대한 유럽 표준으로서, 특히 자가 검진을 위한 IVD MDs를 포함하여 광범위한 적용 범위를 가지고 있습니다. 이 표준은 제조자가 성능 평가 연구의 계획, 수행, 평가 및 문서화에 대한 책임과 일반 요구 사항을 명확히 규정하고 있으며, 특정 IVD MDs 또는 특정 사용에 대한 평가 계획에는 적용되지 않습니다. EN 13612:2002의 가장 큰 강점은 성능 평가 결과를 통해 IVD MD가 제조자가 주장한 대로 작동함을 입증할 수 있도록 도와주는 것입니다. 이는 인증 기관과 국가 당국에 대한 신뢰성을 높이는 데 기여하며, 높은 수준의 성능 데이터를 확보하는 데 필요합니다. 또한 이 표준은 설계 검증 및 설계 변경과 관련된 품질 시스템 준수에 대해서도 다루고 있어, EN ISO 9001, EN 46001, EN 928을 기준으로 체외 진단 의료기기의 성격 및 용도를 고려하고 있습니다. 성능 평가 데이터를 조치하기 위해 적절한 연구에서 나오는 데이터 또는 기존 문헌에서 얻어진 결과를 활용할 수 있도록 하고 있으며, 이는 IVD MDs에 대한 품질 시스템 요구 사항을 충족시키는 데 매우 중요합니다. 이처럼 EN 13612:2002는 체외 진단 의료기기 성능 평가의 체계적이고 표준화된 접근 방식을 제공하며, 각종 기술적 요구 사항을 만족하기 위해 필수적으로 수행해야 할 절차를 제시하고 있습니다. 이러한 전반적인 특성으로 인해, 본 표준은 IVD MDs의 신뢰성과 효율성을 확보하는 데 필수적인 요소로 자리매김하고 있습니다.
The EN 13612:2002 standard provides a comprehensive framework for the performance evaluation of in vitro diagnostic medical devices (IVD MDs), including those intended for self-testing. Its scope is well-defined, focusing on the establishment of responsibilities and general requirements crucial for effective planning, conducting, assessing, and documenting performance evaluation studies by manufacturers. By addressing the intricacies of performance evaluation, the standard ensures that IVD MDs reliably meet their claimed functionalities. One of the notable strengths of this standard is its emphasis on generating credible evidence necessary for regulatory compliance. It mandates that manufacturers present convincing performance evaluation results to notified bodies and national authorities, thereby reinforcing the reliability of IVD MDs in clinical settings. Furthermore, the inclusion of the necessity to establish performance evaluation data through appropriate studies or existing literature adds an important layer of rigor to the evaluation process, ensuring that the data supporting the claims made about IVD MDs are not only adequate but also scientifically validated. The alignment with the principles of quality management systems, as outlined in EN ISO 9001, EN 46001, and EN 928, particularly regarding design validation and design changes, enhances the standard's relevance to manufacturers. It ensures that manufacturers are not only compliant with regulatory requirements but also systematically addressing the quality aspects of their IVD MDs, which is crucial in a sector where precision and reliability are paramount. Overall, the EN 13612:2002 standard is an essential tool for manufacturers of IVD MDs. Its structured approach to performance evaluation solidifies the foundation for producing safe and effective diagnostic products, thus playing a pivotal role in public health and patient safety.
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