2017/746 - Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU Harmonized Directive
Regulation (EU) 2017/746 establishes a comprehensive regulatory framework for in vitro diagnostic medical devices (IVDs) to ensure high levels of safety, health protection, and innovation within the internal market. Replacing Directive 98/79/EC, it harmonizes rules on placing IVDs on the EU market and emphasizes robust conformity assessment, risk classification, performance evaluation, and enhanced transparency through Unique Device Identification (UDI) systems. The Regulation sets out clear obligations for manufacturers, importers, distributors, and authorized representatives, including quality management, post-market surveillance, and vigilance requirements, with attention to genetic testing and companion diagnostics. It distinguishes in vitro diagnostic devices from other product categories and allows health institutions to manufacture devices for in-house use under specific conditions. The Regulation also mandates the creation of a European database (Eudamed) to improve information access and regulatory oversight. It aims to facilitate free movement of compliant devices while promoting patient safety, public health, and global regulatory convergence through alignment with international standards and practices.
Purpose
Regulation (EU) 2017/746 establishes a comprehensive regulatory framework specifically for in vitro diagnostic medical devices (IVDs) within the European Union. It replaces Directive 98/79/EC and Commission Decision 2010/227/EU to provide a higher level of safety and performance while fostering innovation and supporting the smooth functioning of the internal market. A key aim is harmonizing the rules for placing IVDs on the EU market, ensuring free movement of these devices while maintaining high health protection for patients and users.
The regulation addresses unique characteristics of IVDs, such as risk classification, conformity assessment, clinical evidence, and market surveillance. Additionally, it aims to increase transparency, traceability, and accountability for manufacturers and other economic operators. It also clarifies the regulatory scope concerning other types of products like medicinal products, general laboratory products, and research-use-only products. The Regulation recognizes the importance of consistency across Member States and empowers the European Commission to make binding decisions on borderline products.
Key Obligations
- Manufacturers must ensure devices meet high safety and performance standards. This includes implementing robust quality management systems, post-market surveillance, and risk management procedures proportionate to the device risk class.
- Clinical Evidence Requirements: Devices must undergo clinical performance evaluation and performance studies with reliable and robust data, ensuring the protection of subjects involved.
- Conformity Assessment: Manufacturers must follow specific conformity assessment procedures, including those involving notified bodies, aligned with internationally recognized guidelines and standards.
- Traceability: Devices must be marked with a Unique Device Identification (UDI) system to enhance traceability, prevent medical errors, and facilitate market surveillance.
- Authorized Representatives: For manufacturers outside the EU, an authorized representative established in the Union is required who shares legal liability and ensures compliance.
- Economic Operators: Importers, distributors, and other operators also have specified responsibilities for safety, compliance, and ensuring devices placed on the market meet regulatory requirements.
- Transparency and Information: The Regulation requires the establishment of the European Database on Medical Devices (Eudamed) to provide transparency about devices available on the market, economic operators, conformity assessments, vigilance activities, and more.
- In-House Manufacturing: Health institutions may manufacture and use devices in-house under certain restrictions, addressing specific patient needs not met by commercially available devices.
- Companion Diagnostics: Devices essential for identifying patient eligibility for specific medicinal treatments are regulated as IVDs under this Regulation.
- Prohibition of Barriers: Member States must not obstruct the placing on the market or putting into service of compliant devices but may restrict use on non-covered aspects.
Affected Products and Actors
- Products: In vitro diagnostic medical devices including reagents, instruments, software specifically intended for diagnostic medical purposes, companion diagnostics, and genetic tests providing disease predisposition or treatment response information.
- Excluded Products: Products for research use only, general laboratory products, devices used solely for monitoring treatment concentrations in the body (not considered companion diagnostics).
- Actors: Manufacturers, authorized representatives, importers, distributors, notified bodies, health institutions acting as manufacturers for in-house devices, and competent authorities responsible for market surveillance and enforcement.
- Software: When intended by the manufacturer for diagnostic purposes as defined in the Regulation, software is considered an IVD.
Implementation Timeline
- The Regulation was adopted on 5 April 2017.
- Full application commenced on 26 May 2022, following a five-year transition period after repeal of Directive 98/79/EC.
- During the transition, manufacturers were required to comply progressively with new provisions including conformity assessment and UDI implementation.
- Member States were tasked with adopting necessary national measures to enforce the Regulation on the same timeline.
- The European Database on Medical Devices (Eudamed) was planned for staged deployment coinciding with full application, aimed at enabling comprehensive oversight of devices once fully functional.
This Regulation sets the foundation for a harmonized, transparent and robust regulatory environment for in vitro diagnostic medical devices, prioritizing patient safety, supporting technological advancement, and facilitating the internal market within the European Union.
This Regulation applies to in vitro diagnostic medical devices and their accessories intended to be used in vitro for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. It includes devices such as genetic tests and companion diagnostics, which identify patients' eligibility for specific medicinal treatments. The Regulation covers devices offered within the EU market, including those made available via information society services and used in commercial diagnostic or therapeutic activities. Software specifically intended for diagnostic medical purposes also falls within its scope. The Regulation excludes products whose primary purpose are general laboratory use, research use only, or those manufactured and used within a single health institution on a non-industrial scale, as well as establishments focused on wellness rather than health care. The scope also covers conformity assessment, placing on the market, post-market surveillance, vigilance, and market surveillance of these devices within the EU internal market.
Die Verordnung (EU) 2017/746 regelt In-vitro-Diagnostika in der EU und ersetzt die Richtlinie 98/79/EG. Sie zielt darauf ab, einen harmonisierten, sicheren Rechtsrahmen für In-vitro-Diagnostika zu schaffen, der sowohl die Gesundheit und Sicherheit von Patienten und Anwendern schützt als auch Innovationen fördert. Die Verordnung umfasst umfangreiche Anforderungen an Qualität, Risikoklassifizierung, Konformitätsbewertung, Leistungsbewertung, Vigilanz und Marktüberwachung. Sie definiert auch die Rolle von Herstellern, Importeuren, Händlern und Bevollmächtigten und stellt sicher, dass alle Produkte mit der CE-Kennzeichnung versehen sind. Besondere Regelungen gelten für Produkte, die in Gesundheitseinrichtungen hergestellt oder verwendet werden. Die Verordnung fördert zudem die internationale Harmonisierung durch Berücksichtigung internationaler Leitlinien. Sie stellt klare Anforderungen an klinische Studien, den Schutz von Studienteilnehmern und das Risikomanagement. Ziel ist ein hoher Gesundheitsschutz bei gleichzeitig funktionsfähigem Binnenmarkt für In-vitro-Diagnostika.
Zweck
Die Verordnung (EU) 2017/746 zielt darauf ab, einen einheitlichen und hochsicheren Rechtsrahmen für In-vitro-Diagnostika (IVD) innerhalb des EU-Binnenmarktes zu schaffen. Dabei soll ein hohes Niveau an Gesundheitsschutz für Patienten und Anwender gewährleistet und zugleich Innovation gefördert werden. Die Verordnung ersetzt die bisherige Richtlinie 98/79/EG und legt besonderen Wert auf Qualität, Sicherheit, Transparenz und Rückverfolgbarkeit der Produkte. Sie verfolgt parallel die Ziele eines reibungslosen Binnenmarktes und hoher Standards speziell durch:
- Harmonisierung der Rechtsvorschriften zum Inverkehrbringen und zur Inbetriebnahme von IVD-Produkten
- Stärkung der Überwachung von Benannten Stellen, Risikoklassifizierung und Vigilanz
- Einbindung internationaler Leitlinien zur Förderung der globalen Harmonisierung
Die Verordnung regelt zudem spezifisch Fragen rund um Leistungsbewertung, klinische Nachweise, Leistungsstudien sowie Marktüberwachung. Ziel ist es auch, die Stellung von Software als IVD zu definieren sowie den Umgang mit therapiebegleitenden Diagnostika.
Wichtige Verpflichtungen
- Herstellerpflichten: Einführung eines angepassten Qualitätsmanagementsystems, Risikomanagement sowie Überwachung nach dem Inverkehrbringen. Hersteller müssen für finanzielle Haftungskapazitäten sorgen.
- Konformitätsbewertung: Je nach Risikoklasse sind unterschiedliche Konformitätsverfahren durchzuführen, inklusive klinischer Leistungsbewertung.
- CE-Kennzeichnung: Produkte müssen mit der CE-Kennzeichnung versehen werden, die ihre Übereinstimmung mit den Vorgaben dokumentiert.
- Bevollmächtigte und Importeure: Für Hersteller außerhalb der EU müssen Bevollmächtigte benannt werden, die auch haftbar gemacht werden können.
- Marktüberwachung und Vigilanz: Verpflichtung zur Meldung von Vorkommnissen und Ergreifen von Sicherheitskorrekturmaßnahmen.
- Risikoklassifizierung: Neue, strengere Kriterien zur Einstufung von In-vitro-Diagnostika, mit besonderem Fokus auf Patientensicherheit.
- Transparenz und Rückverfolgbarkeit: Einführung einer einheitlichen Produktkennung (UDI - Unique Device Identification).
- Regelungen zum parallelen Handel: Klare Vorgaben zum Umpacken und Neukennzeichnen im Binnenmarkt.
- Regelungen zur Nutzung in Gesundheitseinrichtungen: Besondere Ausnahmen für hausintern hergestellte IVD zur Deckung spezifischer Patientenbedürfnisse.
Betroffene Produkte und Akteure
- Produkte: Alle In-vitro-Diagnostika, inklusive Gentests, therapiebegleitende Diagnostika sowie spezifische Software, die für medizinische Zwecke entwickelt wurde.
- Hersteller: Unternehmen, die IVD-Produkte entwickeln, herstellen oder in Verkehr bringen.
- Importeure und Händler: Akteure, die IVD-Produkte in die EU importieren oder vertreiben, mit klar definierten Pflichten und Verantwortlichkeiten.
- Bevollmächtigte: Vertreter von außereuropäischen Herstellern, die für die Konformität und Erfüllung der Verordnung verantwortlich sind.
- Gesundheitseinrichtungen: Einrichtungen, die eigene IVD-Produkte im nicht-industrialisierten Maßstab herstellen und verwenden, z.B. Krankenhäuser und Labore.
- Benannte Stellen: Organisationen, die begutachtende Aufgaben der Konformitätsbewertung ausüben.
Umsetzungszeitplan
- Die Verordnung (EU) 2017/746 wurde am 5. April 2017 verabschiedet.
- Die Übergangsfrist betrug fünf Jahre, sodass die Verordnung ab dem 26. Mai 2022 unmittelbar gilt und die bisherige Richtlinie 98/79/EG ersetzt.
- In dieser Zeit mussten Hersteller und andere Wirtschaftsakteure ihre Produkte und Prozesse an die neuen Anforderungen anpassen, insbesondere bezüglich der Klassifizierung und Zertifizierung durch Benannte Stellen.
- Einige spezifische Regelungen und Änderungen im Marktüberwachungs- und Vigilanzsystem sind in den folgenden Jahren fortlaufend umzusetzen und anzupassen.
Die Verordnung stellt für alle beteiligten Akteure einen tiefgreifenden Paradigmenwechsel dar, der das Ziel verfolgt, Sicherheit, Qualität und Transparenz von In-vitro-Diagnostika in der EU auf ein hohes und einheitlich kontrolliertes Niveau zu bringen.
Die Verordnung (EU) 2017/746 gilt für In-vitro-Diagnostika und deren Zubehör. Sie harmonisiert die Vorschriften für das Inverkehrbringen und die Inbetriebnahme dieser Produkte innerhalb des Unionsmarktes, um ein hohes Sicherheits- und Qualitätsniveau zu gewährleisten und gleichzeitig Innovationen zu fördern. Als In-vitro-Diagnostika gelten dabei Produkte, die zum medizinischen Zweck der Untersuchung von Proben aus dem menschlichen Körper bestimmt sind, einschließlich Gentests und therapiebegleitender Diagnostika. Die Verordnung erstreckt sich auf Hersteller, Importeure, Händler und andere Wirtschaftsakteure im Bereich der In-vitro-Diagnostika. Ausgenommen sind Produkte für allgemeine Laborzwecke, reine Forschungsprodukte sowie Produkte, die ausschließlich in Gesundheitseinrichtungen hergestellt und verwendet werden, sofern sie nicht industriell gefertigt werden. Software, die speziell für einen medizinischen Zweck als In-vitro-Diagnostikum bestimmt ist, fällt ebenfalls in den Anwendungsbereich. Die Verordnung strebt zudem eine klare Abgrenzung zu anderen Rechtsvorschriften an und fördert die internationale Harmonisierung.
Le règlement (UE) 2017/746 établit un cadre réglementaire rigoureux, transparent et durable pour les dispositifs médicaux de diagnostic in vitro (DIV) dans l’Union européenne, remplaçant la directive 98/79/CE. Il vise à garantir un haut niveau de sécurité et de protection de la santé des patients et des utilisateurs, tout en soutenant l'innovation et en tenant compte des petites et moyennes entreprises du secteur. Le texte harmonise les conditions de mise sur le marché et de mise en service des DIV, renforce la classification basée sur le risque, améliore les procédures d’évaluation de conformité, d’évaluation et d’études des performances, ainsi que la vigilance et la surveillance après commercialisation. Il inclut aussi des règles sur la traçabilité, la transparence et la coordination internationale. Le règlement précise les responsabilités des fabricants, importateurs, distributeurs et mandataires, introduit des exigences spécifiques pour les dispositifs fabriqués et utilisés in situ dans les établissements de santé et précise les modalités liées aux logiciels considérés comme DIV. Enfin, il vise à garantir la cohérence dans l’application et la surveillance réglementaire afin de favoriser la libre circulation des DIV au sein du marché intérieur tout en assurant la sécurité sanitaire.
Objet
Le Règlement (UE) 2017/746, relatif aux dispositifs médicaux de diagnostic in vitro (DMDIV), instaure un cadre réglementaire rigoureux, transparent et durable afin de garantir un niveau élevé de sécurité et de protection de la santé pour les patients et les utilisateurs. Il vise à harmoniser les règles de mise sur le marché et de mise en service des DMDIV au sein de l’Union européenne, assurant ainsi le bon fonctionnement du marché intérieur tout en favorisant l’innovation. Ce règlement remplace la directive 98/79/CE et la décision 2010/227/UE de la Commission.
Obligations clés
- Renforcement de la supervision des organismes notifiés chargés de l’évaluation de la conformité des dispositifs.
- Classification des dispositifs selon leur niveau de risque, avec des règles spécifiques adaptées à chaque classe.
- Procédures d’évaluation de la conformité plus strictes, incluant notamment des études et évaluations des performances des dispositifs.
- Surveillance après commercialisation renforcée, avec des systèmes de vigilance et de gestion des incidents.
- Transparence et traçabilité accrue des dispositifs via notamment l’identification unique des dispositifs (UDI).
- Obligations pour les opérateurs économiques : fabricants, importateurs, distributeurs et mandataires doivent respecter des règles claires quant à la mise sur le marché, la documentation technique, la gestion des risques et la fourniture d’information.
- Exigences spécifiques pour les dispositifs fabriqués et utilisés au sein des établissements de santé : possibilité de fabriquer et modifier des dispositifs pour un usage interne, sous certaines conditions et sans appliquer toutes les exigences du règlement.
- Responsabilités solidaires entre fabricants, mandataires et importateurs concernant les dispositifs défectueux.
- Respect des normes harmonisées pour prouver la conformité des dispositifs aux exigences générales de sécurité et de performance.
Produits et acteurs concernés
- Tous les dispositifs médicaux destinés au diagnostic in vitro, y compris :
- Les tests génétiques.
- Les diagnostics compagnons (dispositifs permettant de déterminer la réponse à un traitement médicamenteux).
- Les logiciels spécifiquement destinés à des fins médicales dans ce domaine.
- Sont exclus les dispositifs médicaux de diagnostic autres que ceux in vitro, les produits destinés uniquement à la recherche, ou les dispositifs de seconde main remis à disposition sur le marché.
- Les opérateurs économiques impliqués dans la chaîne de mise sur le marché : fabricants, importateurs, distributeurs, mandataires.
- Les établissements de santé fabriquant ou modifiant des dispositifs pour un usage interne.
- La Commission européenne, les autorités nationales compétentes, et les organismes notifiés sont responsables de la mise en œuvre, du contrôle et de la surveillance.
Calendrier de mise en œuvre
- Le règlement est entré en vigueur le 26 mai 2017.
- Une période transitoire permet l’adaptation progressive des opérateurs économiques et des autorités compétentes.
- La majorité des dispositions doivent être appliquées intégralement après une période de transition pouvant aller jusqu’à mai 2022, avec des délais spécifiques en fonction de la classe des dispositifs et de la complexité des exigences.
- Les États membres doivent mettre en place les dispositifs nécessaires pour assurer l’application effective du règlement, notamment en matière d’organisation des autorités compétentes et de surveillance du marché.
- La Commission est habilitée à adopter des actes délégués et d’exécution pour préciser certaines dispositions techniques et assurer une harmonisation continue.
Ce règlement constitue un cadre juridique moderne et strict qui entend garantir la sécurité, la performance et la fiabilité des dispositifs médicaux de diagnostic in vitro à travers l’Union, tout en soutenant la compétitivité du secteur et la protection des patients.
Le règlement (UE) 2017/746 s'applique aux dispositifs médicaux de diagnostic in vitro (DMDIV) destinés à être utilisés pour des examens effectués in vitro sur des échantillons prélevés sur le corps humain, dans le but notamment de fournir des informations concernant un état physiologique ou pathologique, une prédisposition à une maladie, ou la réaction à un traitement. Il couvre également les accessoires de ces dispositifs. Le champ d’application exclut explicitement les dispositifs déjà mis en service et revendus (vente de seconde main). Le règlement concerne la fabrication, la mise sur le marché, la mise en service, l’évaluation, la surveillance, la traçabilité, et les exigences de sécurité et de performance des DMDIV. Il s'applique aux logiciels spécifiquement destinés à des fins médicales comme dispositifs médicaux de diagnostic in vitro, mais pas aux logiciels à usage général ou destinés au bien-être. Les établissements de santé peuvent utiliser ou fabriquer des dispositifs en interne pour répondre à des besoins spécifiques, sous certaines conditions. Le règlement vise à renforcer la sécurité des patients et utilisateurs tout en assurant le bon fonctionnement du marché intérieur dans ce secteur.
Uredba (EU) 2017/746 določa regulativni okvir za in vitro diagnostične medicinske pripomočke (IVD), z namenom zagotavljanja visoke ravni varnosti in zdravja pacientov ter uporabnikov pri hkratni podpori inovacijam. Razveljavlja Direktivo 98/79/ES in uvaja strožje zahteve glede razvrstitve glede na tveganje, postopkov ocenjevanja skladnosti, kliničnih dokazov, nadzora po dajanju na trg ter sistemov za spremljanje varnosti pripomočkov. Posebno pozornost namenja izdelkom, ki so izdelani in uporabljeni znotraj zdravstvenih ustanov, specifični programski opremi, kot tudi dopolnilni diagnostiki, ki določa ustreznost zdravljenja. Uredba uvaja tudi sistem edinstvene identifikacije pripomočkov (UDI) za izboljšanje sledljivosti in varnostnega nadzora ter vzpostavlja evropsko podatkovno zbirko Eudamed za večjo preglednost in učinkovitost upravljanja informacij. Poleg uskladitve zahtev s trenutnimi tehničnimi in varnostnimi standardi, uredba določajo obveznosti proizvajalcev, uvoznikov, distributerjev in pooblaščenih predstavnikov, kar prispeva k zagotavljanju skladnosti in nadzora na trgu EU. Namen uredbe je podpreti nemoteno delovanje notranjega trga z učinkovitimi in transparentnimi regulativnimi postopki v sektorju IVD.
Namen
Uredba (EU) 2017/746 o in vitro diagnostičnih medicinskih pripomočkih (IVD) je namenjena vzpostavitvi trdnega, preglednega, predvidljivega in trajnostnega regulativnega okvira za IVD pripomočke v Evropski uniji. Glavni cilji so:
- Zagotoviti visoko raven varnosti in zdravja pacientov ter uporabnikov.
- Podpreti inovacije v sektorju IVD pripomočkov.
- Omogočiti nemoteno delovanje notranjega trga s skladnostjo z načelom prostega pretoka blaga.
- Postaviti visoke standarde kakovosti in varnosti.
Uredba nadomešča Direktivo 98/79/ES in Komisijski sklep 2010/227/EU ter zagotavlja uskladitev pravil glede designa, proizvodnje, ocenjevanja učinkovitosti, nadzora po dajanju na trg, vigilance ter nadzora trga. Prav tako uvaja sistem edinstvene identifikacije pripomočkov (UDI), ki povečuje sledljivost in učinkovitost varnostnih ukrepov.
Ključne obveznosti
Proizvajalci: Zagotoviti morajo razvrščanje pripomočkov po tveganju, opraviti postopke ugotavljanja skladnosti, oceniti učinkovitost izdelkov preko kliničnih študij, vzpostaviti sisteme upravljanja kakovosti, nadzora po dajanju na trg in obvladovanja tveganja. Prav tako morajo za pripomočke zagotoviti oznako CE in upoštevati zahtevane standarde ter tehnične specifikacije.
Pooblaščeni predstavniki: Za proizvajalce zunaj EU so odgovorni za skladnost pripomočkov in nosijo solidarno pravno odgovornost v primeru nepravilnosti.
Uvozniki in distributerji: Morajo zagotoviti, da pripomočki izpolnjujejo zahteve uredbe, oskrbovati pripomočke v skladu s pravili in delovati transparentno.
Zdravstvene ustanove: Lahko v okviru lastnih potreb proizvajajo in uporabljajo pripomočke za specifične paciente brez polne skladnosti z uredbo, vendar le v neindustrijskem obsegu. Izjema velja za komercialne subjekte.
Priglašeni organi: Izvajajo postopke ocenjevanja skladnosti in nadzorujejo skladnost pripomočkov pred in po dajanju na trg.
Komisija in države članice: Zagotoviti morajo usklajeno izvajanje uredbe, imeti nadzor nad trgovanjem in določati mejne primere vključevanja izdelkov v področje uporabe uredbe.
Skrb za varnost: Uvedba sistema UDI za vse IVD pripomočke poenostavlja nadzor in preprečuje ponarejanje. Prav tako je vzpostavljena evropska podatkovna zbirka Eudamed za zbiranje informacij o pripomočkih, gospodarskih subjektih, priglašenih organih, študijah učinkovitosti, vigilanci in nadzoru trga.
Prizadeti izdelki in akterji
Izdelki: Vsa opredeljena in vitro diagnostična medicinska oprema, vključno z genetskimi testi, dopolnilno diagnostiko, programsko opremo posebnim medicinskim namenom, in pripomočki za spremljanje, čeprav slednji niso del dopolnilne diagnostike.
Gospodarski subjekti: Proizvajalci (vključno z zdravstvenimi ustanovami, kadar proizvajajo pripomočke za lastno rabo), uvozniki, distributerji, pooblaščeni predstavniki, zdravstvene ustanove, priglašeni organi in nadzorni organi.
Zdravstvene ustanove: Bolnišnice, laboratoriji, javne zdravstvene ustanove, ki uporabljajo IVD pripomočke za diagnostiko; niso pa vključene institucije za širše zdravje, kot so fitnes centri ali zdravilišča.
Regulatorni organi: Države članice in Evropska komisija, ki je pristojna za usklajevanje in odločanje o mejnih primerih.
Časovni okvir izvedbe
- Uredba je bila sprejeta 5. aprila 2017.
- Začetek uporabe uredbe je bil določen po prehodnem obdobju za držav članice in gospodarske subjekte, v katerem so lahko še delovali po Direktivi 98/79/ES.
- Postopno izvajanje sistemov, kot je UDI in evropske baze podatkov Eudamed, je bilo načrtovano skladno z namenom povečanja varnosti in preglednosti v naslednjih letih po začetku veljavnosti uredbe.
- Države članice so morale uredbo implementirati v svojih pravnih sistemih v predpisanih rokih, kjer je to potrebno, zlasti na ravni pristojnih organov in mehanskih postopkov nadzora.
Uredba 2017/746 vzpostavlja trajen in integriran sistem za regulacijo in vitro diagnostičnih medicinskih pripomočkov, ki krepi zaščito pacientov, spodbuja inovacije in zagotavlja pošteno in učinkovito delovanje notranjega trga EU.
Uredba (EU) 2017/746 se nanaša na in vitro diagnostične medicinske pripomočke, ki se uporabljajo za testiranje vzorcev, odvzetih iz človeškega telesa, za namen diagnosticiranja, spremljanja in ocenjevanja stanja ali bolezni. Vključuje pripomočke, kot so genetski testi, dopolnilna diagnostika ter programska oprema, namenjena medicinskim uporabam. Uredba zajema proizvajalce, distributerje in uvoznike teh pripomočkov ter njihove postopke postavljanja na trg in uporabo znotraj EU. Izvzeti so izdelki, namenjeni le za raziskave ter nekateri pripomočki, ki jih proizvajajo in uporabljajo izključno zdravstvene ustanove za lastno rabo. Direktiva ureja visoke standarde kakovosti, varnosti, ocene učinkovitosti ter spremljanje varnosti po dajanju pripomočkov na trg, da bi zagotovila prost pretok blaga in zaščito zdravja pacientov in uporabnikov.
General Information
This document specifies requirements for reference measurement procedures (RMP) for measurands used in laboratory medicine.
This document applies to:
RMPs providing values of differential or rational quantities where each quantity value is a numerical value multiplied by a measurement unit. Annex A provides information on ordinal quantities and nominal properties;
any person, body or institution developing RMPs for measurands used in laboratory medicine.
- Standard37 pagesEnglish languagee-Library read for1 day
This document specifies requirements for certified reference materials (CRMs) of higher metrological order and the content of the supporting documentation and the calibration hierarchies as described in ISO 17511:2020, 5.2.1, 5.3.1, 5.4.1, 5.5.1, 5.6.1, 5.7.1. It is applicable to CRMs intended for use as either primary reference materials (PRMs), secondary calibrators or international conventional calibrators within calibration hierarchies appropriate for measurands used in laboratory medicine, or for applications as trueness controls. It also specifies requirements for determining the certified value of a CRM, including evaluation, and reporting of the assigned uncertainty.
This document is applicable primarily to CRMs with assigned property values where the property has a magnitude that can be expressed as a quantitative scalar number or ratio to a reference or refers to a counting scale as also described in ISO 17511:2020, Clause 1.
When a CRM includes multiple measurands, this document is applied to each of the certified quantity values present in the CRM.
Although intended to be applicable to producers of CRMs, this document is also useful for reference materials (RMs) that are not in conformity with the full metrological requirements of CRMs. For example, this document does not apply to an RM created by an in vitro diagnostic medical device (IVD MD) manufacturer for use as working calibrator or end-user calibrator within a calibration hierarchy traceable to a CRM, although some content can be useful in assessing its performance.
- Standard32 pagesEnglish languagee-Library read for1 day
This document specifies requirements for certified reference materials (CRMs) of higher metrological order and the content of the supporting documentation and the calibration hierarchies as described in ISO 17511:2020, 5.2.1, 5.3.1, 5.4.1, 5.5.1, 5.6.1, 5.7.1. It is applicable to CRMs intended for use as either primary reference materials (PRMs), secondary calibrators or international conventional calibrators within calibration hierarchies appropriate for measurands used in laboratory medicine, or for applications as trueness controls. It also specifies requirements for determining the certified value of a CRM, including evaluation, and reporting of the assigned uncertainty.
This document is applicable primarily to CRMs with assigned property values where the property has a magnitude that can be expressed as a quantitative scalar number or ratio to a reference or refers to a counting scale as also described in ISO 17511:2020, Clause 1.
When a CRM includes multiple measurands, this document is applied to each of the certified quantity values present in the CRM.
Although intended to be applicable to producers of CRMs, this document is also useful for reference materials (RMs) that are not in conformity with the full metrological requirements of CRMs. For example, this document does not apply to an RM created by an in vitro diagnostic medical device (IVD MD) manufacturer for use as working calibrator or end-user calibrator within a calibration hierarchy traceable to a CRM, although some content can be useful in assessing its performance.
- Standard32 pagesEnglish languagee-Library read for1 day
This document specifies requirements for reference measurement procedures (RMP) for measurands used in laboratory medicine.
This document applies to:
RMPs providing values of differential or rational quantities where each quantity value is a numerical value multiplied by a measurement unit. Annex A provides information on ordinal quantities and nominal properties;
any person, body or institution developing RMPs for measurands used in laboratory medicine.
- Standard37 pagesEnglish languagee-Library read for1 day
1.1 This document specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices.
NOTE Although the scope is limited to medical devices, this document can be applicable to other products and equipment.
This document covers radiation processes employing irradiators using:
a) the radionuclide 60Co or 137Cs;
b) a beam from an electron generator; or
c) a beam from an X-ray generator.
1.2 This document is not applicable to processes for inactivating viruses or the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease.
NOTE For information on such processes, see ISO 22442-1, ISO 22442-2, ISO 22442-3, ISO 13022 and ICH Q5A.
1.2.1 This document does not specify requirements for designating a medical device as sterile.
NOTE Regional and national requirements can designate medical devices as sterile. See, for example, EN 556-1 or ANSI/AAMI ST67.
1.2.2 This document does not specify a quality management system for the control of all stages of production of medical devices.
NOTE It is not a requirement of this document to have a complete quality management system during manufacture, but the elements of a quality management system that are the minimum necessary to control the sterilization process are normatively referenced at appropriate places in the text (see, in particular, Clause 4). Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production of medical devices, including the sterilization process. Regional and national regulations for the provision of medical devices can require implementation of a complete quality management system and the assessment of that system by a third party.
1.2.3 This document does not require that biological indicators be used for validation or monitoring of radiation sterilization, nor does it require that a pharmacopoeial test for sterility be carried out for product release.
1.2.4 This document does not specify requirements for occupational safety associated with the design and operation of irradiation facilities.
NOTE Regulations on safety requirements for occupational safety related to radiation can exist in some countries.
1.2.5 This document does not specify requirements for the sterilization of used or reprocessed devices.
- Standard61 pagesEnglish languagee-Library read for1 day
1.1 This document specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices.
NOTE Although the scope is limited to medical devices, this document can be applicable to other products and equipment.
This document covers radiation processes employing irradiators using:
a) the radionuclide 60Co or 137Cs;
b) a beam from an electron generator; or
c) a beam from an X-ray generator.
1.2 This document is not applicable to processes for inactivating viruses or the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease.
NOTE For information on such processes, see ISO 22442-1, ISO 22442-2, ISO 22442-3, ISO 13022 and ICH Q5A.
1.2.1 This document does not specify requirements for designating a medical device as sterile.
NOTE Regional and national requirements can designate medical devices as sterile. See, for example, EN 556-1 or ANSI/AAMI ST67.
1.2.2 This document does not specify a quality management system for the control of all stages of production of medical devices.
NOTE It is not a requirement of this document to have a complete quality management system during manufacture, but the elements of a quality management system that are the minimum necessary to control the sterilization process are normatively referenced at appropriate places in the text (see, in particular, Clause 4). Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production of medical devices, including the sterilization process. Regional and national regulations for the provision of medical devices can require implementation of a complete quality management system and the assessment of that system by a third party.
1.2.3 This document does not require that biological indicators be used for validation or monitoring of radiation sterilization, nor does it require that a pharmacopoeial test for sterility be carried out for product release.
1.2.4 This document does not specify requirements for occupational safety associated with the design and operation of irradiation facilities.
NOTE Regulations on safety requirements for occupational safety related to radiation can exist in some countries.
1.2.5 This document does not specify requirements for the sterilization of used or reprocessed devices.
- Standard61 pagesEnglish languagee-Library read for1 day
NOTE 1 There is guidance or rationale for this Clause in A.2.1.
This document specifies the requirements for information supplied by the manufacturer for a medical device or an accessory, as defined in 3.1. This document includes the generally applicable requirements for identification and labels on a medical device or accessory, the packaging, marking of a medical device or accessory, and accompanying information. This document does not specify the means by which the information is to be supplied.
NOTE 2 Some authorities having jurisdiction impose different requirements for the identification, marking and documentation of a medical device or accessory.
Specific requirements of medical device product standards or group standards take precedence over requirements of this document.
- Standard60 pagesEnglish languagee-Library read for1 day
NOTE 1 There is guidance or rationale for this Clause in A.2.1.
This document specifies the requirements for information supplied by the manufacturer for a medical device or an accessory, as defined in 3.1. This document includes the generally applicable requirements for identification and labels on a medical device or accessory, the packaging, marking of a medical device or accessory, and accompanying information. This document does not specify the means by which the information is to be supplied.
NOTE 2 Some authorities having jurisdiction impose different requirements for the identification, marking and documentation of a medical device or accessory.
Specific requirements of medical device product standards or group standards take precedence over requirements of this document.
- Standard60 pagesEnglish languagee-Library read for1 day
- Amendment38 pagesEnglish languagee-Library read for1 day
- Amendment38 pagesEnglish languagee-Library read for1 day
IEC 61326-2-6:2025 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of IN VITRO DIAGNOSTIC MEDICAL ELECTRICAL EQUIPMENT (IVD MEE). This part of IEC 61326 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of IVD MEE in the presence of electromagnetic disturbances and to electromagnetic disturbances emitted by IVD MEE.
BASIC SAFETY with regard to electromagnetic disturbances is applicable to all IVD MEE.
NOTE 1 Performance with respect to electromagnetic disturbances other than ESSENTIAL PERFORMANCE is the subject of IEC 61326-1:2020
NOTE 2 IT equipment can be a part of an IVD MEE, if it is required to maintain BASIC SAFETY or ESSENTIAL PERFORMANCE.
This edition includes the following significant technical changes with respect to the previous edition:
- Update of the document with respect to test levels and documentation.
- Standard36 pagesEnglish languagee-Library read for1 day
IEC 61326-2-6:2025 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of IN VITRO DIAGNOSTIC MEDICAL ELECTRICAL EQUIPMENT (IVD MEE). This part of IEC 61326 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of IVD MEE in the presence of electromagnetic disturbances and to electromagnetic disturbances emitted by IVD MEE. BASIC SAFETY with regard to electromagnetic disturbances is applicable to all IVD MEE. NOTE 1 Performance with respect to electromagnetic disturbances other than ESSENTIAL PERFORMANCE is the subject of IEC 61326-1:2020 NOTE 2 IT equipment can be a part of an IVD MEE, if it is required to maintain BASIC SAFETY or ESSENTIAL PERFORMANCE. This edition includes the following significant technical changes with respect to the previous edition: - Update of the document with respect to test levels and documentation.
- Standard36 pagesEnglish languagee-Library read for1 day
This document specifies general requirements for non-active surgical implants, hereafter referred to as implants.
This document is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants, intra-ocular lenses and implants utilizing viable animal or human tissue.
With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests to demonstrate compliance with these requirements.
Additional requirements applicable to specific implants or implant families are given or referred to in Level 2 and Level 3 standards.
NOTE 1 This document does not require that the manufacturer have a quality management system in place. However, many regulatory authorities require the application of a quality management system, such as that described in ISO 13485, to ensure that the implant achieves its intended performance and safety.
NOTE 2 In this document, when not otherwise specified, the term "implant" refers to each individual component of a system or a modular implant, provided separately or as a set of components, as well as to all ancillary implants or associated implants designed for improving the intended performance.
- Standard36 pagesEnglish languagee-Library read for1 day
This document specifies general requirements for non-active surgical implants, hereafter referred to as implants.
This document is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants, intra-ocular lenses and implants utilizing viable animal or human tissue.
With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests to demonstrate compliance with these requirements.
Additional requirements applicable to specific implants or implant families are given or referred to in Level 2 and Level 3 standards.
NOTE 1 This document does not require that the manufacturer have a quality management system in place. However, many regulatory authorities require the application of a quality management system, such as that described in ISO 13485, to ensure that the implant achieves its intended performance and safety.
NOTE 2 In this document, when not otherwise specified, the term "implant" refers to each individual component of a system or a modular implant, provided separately or as a set of components, as well as to all ancillary implants or associated implants designed for improving the intended performance.
- Standard36 pagesEnglish languagee-Library read for1 day
This document specifies the requirements for an aseptically processed medical device to be designated “STERILE”.
- Standard17 pagesEnglish languagee-Library read for1 day
This document specifies the requirements for an aseptically processed medical device to be designated “STERILE”.
- Standard17 pagesEnglish languagee-Library read for1 day
This document specifies the requirements for a terminally sterilized medical device to be designated ‘STERILE’. Part 2 of this European standard specifies the requirements for an aseptically processed medical device to be designated "STERILE".
NOTE For the purpose of the EU Directive(s) for medical devices (see Bibliography), designation of a medical device as ‘STERILE’ is only permissible when a validated sterilization process has been applied. Requirements for validation and routine control of processes for the sterilization of medical devices are specified in EN ISO 11135, EN ISO 11137, EN ISO 14160, EN ISO 14937, EN ISO 17665-1, EN ISO 20857, EN ISO 25424 and ISO 22441.
- Standard14 pagesEnglish languagee-Library read for1 day
This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents, calibrators and controls intended for professional use.
This document can also be applicable to accessories.
This document is applicable to the labels for outer and immediate containers and to the instructions for use.
This document does not apply to:
a) IVD instruments or equipment;
b) IVD reagents for self-testing.
- Standard24 pagesEnglish languagee-Library read for1 day
This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for self-testing.
This document is also applicable to apparatus and equipment intended to be used with IVD instruments for self-testing.
This document can also be applicable to accessories.
This document does not apply to:
a) instructions for instrument servicing or repair;
b) IVD reagents, including calibrators and control materials for use in control of the reagent;
c) IVD instruments for professional use.
- Standard21 pagesEnglish languagee-Library read for1 day
This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents, calibrators, and controls intended for self-testing.
This document can also be applicable to accessories.
This document is applicable to the labels for outer and immediate containers and to the instructions for use.
This document does not apply to:
a) IVD instruments or equipment;
b) IVD reagents for professional use.
- Standard24 pagesEnglish languagee-Library read for1 day
This document defines concepts, establishes general principles, and specifies essential requirements for information supplied by the manufacturer of IVD medical devices.
This document does not address language requirements since that is the domain of national laws and regulations.
This document does not apply to:
a) IVD medical devices for performance evaluation (e.g. for investigational use only);
b) shipping documents;
c) material safety data sheets / Safety Data Sheets;
d) marketing information (consistent with applicable legal requirements).
.
- Standard65 pagesEnglish languagee-Library read for1 day
This document specifies the requirements for a terminally sterilized medical device to be designated ‘STERILE’. Part 2 of this European standard specifies the requirements for an aseptically processed medical device to be designated "STERILE".
NOTE For the purpose of the EU Directive(s) for medical devices (see Bibliography), designation of a medical device as ‘STERILE’ is only permissible when a validated sterilization process has been applied. Requirements for validation and routine control of processes for the sterilization of medical devices are specified in EN ISO 11135, EN ISO 11137, EN ISO 14160, EN ISO 14937, EN ISO 17665-1, EN ISO 20857, EN ISO 25424 and ISO 22441.
- Standard14 pagesEnglish languagee-Library read for1 day
This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for professional use.
This document also applies to apparatus and equipment intended to be used with IVD instruments for professional use.
This document can also be applicable to accessories.
This document does not apply to:
a) instructions for instrument servicing or repair;
b) IVD reagents, including calibrators and control materials for use in control of the reagent;
c) IVD instruments for self-testing.
- Standard22 pagesEnglish languagee-Library read for1 day
This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents, calibrators and controls intended for professional use.
This document can also be applicable to accessories.
This document is applicable to the labels for outer and immediate containers and to the instructions for use.
This document does not apply to:
a) IVD instruments or equipment;
b) IVD reagents for self-testing.
- Standard24 pagesEnglish languagee-Library read for1 day
This document defines concepts, establishes general principles, and specifies essential requirements for information supplied by the manufacturer of IVD medical devices.
This document does not address language requirements since that is the domain of national laws and regulations.
This document does not apply to:
a) IVD medical devices for performance evaluation (e.g. for investigational use only);
b) shipping documents;
c) material safety data sheets / Safety Data Sheets;
d) marketing information (consistent with applicable legal requirements).
.
- Standard65 pagesEnglish languagee-Library read for1 day
This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents, calibrators, and controls intended for self-testing.
This document can also be applicable to accessories.
This document is applicable to the labels for outer and immediate containers and to the instructions for use.
This document does not apply to:
a) IVD instruments or equipment;
b) IVD reagents for professional use.
- Standard24 pagesEnglish languagee-Library read for1 day
This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for professional use.
This document also applies to apparatus and equipment intended to be used with IVD instruments for professional use.
This document can also be applicable to accessories.
This document does not apply to:
a) instructions for instrument servicing or repair;
b) IVD reagents, including calibrators and control materials for use in control of the reagent;
c) IVD instruments for self-testing.
- Standard22 pagesEnglish languagee-Library read for1 day
This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for self-testing.
This document is also applicable to apparatus and equipment intended to be used with IVD instruments for self-testing.
This document can also be applicable to accessories.
This document does not apply to:
a) instructions for instrument servicing or repair;
b) IVD reagents, including calibrators and control materials for use in control of the reagent;
c) IVD instruments for professional use.
- Standard21 pagesEnglish languagee-Library read for1 day
This document provides requirements for the development, validation and routine control of moist heat sterilization processes for medical devices. It also contains guidance which is intended to explain the requirements set forth in the normative sections. The guidance given is intended to promote good practice related to moist heat sterilization processes according to this document. The application within industrial and health care settings is considered.
- Standard172 pagesEnglish languagee-Library read for1 day
This document specifies the general requirements for, and offers guidance on, processes, programs and procedures for development, validation and routine control of aseptic processing of health care products.
This document includes requirements and guidance relative to the overall topic of aseptic processing.
Specific requirements and guidance on various specialized processes and methods related to sterilizing filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in the other parts of the ISO 13408 series.
- Standard91 pagesEnglish languagee-Library read for1 day
This document provides requirements for the development, validation and routine control of moist heat sterilization processes for medical devices. It also contains guidance which is intended to explain the requirements set forth in the normative sections. The guidance given is intended to promote good practice related to moist heat sterilization processes according to this document. The application within industrial and health care settings is considered.
- Standard172 pagesEnglish languagee-Library read for1 day
This document specifies the general requirements for, and offers guidance on, processes, programs and procedures for development, validation and routine control of aseptic processing of health care products.
This document includes requirements and guidance relative to the overall topic of aseptic processing.
Specific requirements and guidance on various specialized processes and methods related to sterilizing filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in the other parts of the ISO 13408 series.
- Standard91 pagesEnglish languagee-Library read for1 day
This document defines good study practice for the planning, design, conduct, recording and reporting of clinical performance studies carried out to assess the clinical performance and safety of in vitro diagnostic (IVD) medical devices for regulatory purposes.
NOTE 1 The purpose of these studies is to assess the ability of an IVD medical device in the hands of the intended user, to yield results pertaining to a particular medical condition or physiological/pathological state, in the intended population.
The document is not intended to describe whether the technical specifications of the IVD medical device in question are adequately addressed by the clinical performance study.
This document identifies the principles that underpin clinical performance studies and specifies general requirements intended to
— ensure the conduct of the clinical performance study will lead to reliable and robust study results,
— define the responsibilities of the sponsor and principal investigator,
— assist sponsors, clinical research organization, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of IVD medical devices, and
— protect the rights, safety, dignity and well-being of the subjects providing specimens for use in clinical performance studies.
Analytical performance studies are out of the scope of this document.
NOTE 2 When the collection of specimens specifically for the analytical performance study creates an additional collection risk for subjects, some of the elements of this document (particularly the annexes) can be useful for ensuring subject safety.
Clinical performance studies that are performed for reasons other than pre- and post-market regulatory purposes, such as for re-imbursement purposes, are out of the scope of this document.
NOTE 3 Some of the elements of this document can be useful for the design of such studies, including subject safety and data integrity.
This document does not include safety information for laboratory workers or other personnel collecting the study specimens.
NOTE 4 Such information is included in other publications[1][12][13].
NOTE 5 Users of this document can consider whether other standards and/or requirements also apply to the IVD medical device which is the subject of the clinical performance study, for instance, in the situation for which there is an IVD medical device and a medical device used in an integrated system (e.g. a lancet, an IVD test strip, and a glucose meter), aspects of both this document and ISO 14155 can be considered.
- Standard72 pagesEnglish languagee-Library read for1 day
This document defines good study practice for the planning, design, conduct, recording and reporting of clinical performance studies carried out to assess the clinical performance and safety of in vitro diagnostic (IVD) medical devices for regulatory purposes.
NOTE 1 The purpose of these studies is to assess the ability of an IVD medical device in the hands of the intended user, to yield results pertaining to a particular medical condition or physiological/pathological state, in the intended population.
The document is not intended to describe whether the technical specifications of the IVD medical device in question are adequately addressed by the clinical performance study.
This document identifies the principles that underpin clinical performance studies and specifies general requirements intended to
— ensure the conduct of the clinical performance study will lead to reliable and robust study results,
— define the responsibilities of the sponsor and principal investigator,
— assist sponsors, clinical research organization, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of IVD medical devices, and
— protect the rights, safety, dignity and well-being of the subjects providing specimens for use in clinical performance studies.
Analytical performance studies are out of the scope of this document.
NOTE 2 When the collection of specimens specifically for the analytical performance study creates an additional collection risk for subjects, some of the elements of this document (particularly the annexes) can be useful for ensuring subject safety.
Clinical performance studies that are performed for reasons other than pre- and post-market regulatory purposes, such as for re-imbursement purposes, are out of the scope of this document.
NOTE 3 Some of the elements of this document can be useful for the design of such studies, including subject safety and data integrity.
This document does not include safety information for laboratory workers or other personnel collecting the study specimens.
NOTE 4 Such information is included in other publications[1][12][13].
NOTE 5 Users of this document can consider whether other standards and/or requirements also apply to the IVD medical device which is the subject of the clinical performance study, for instance, in the situation for which there is an IVD medical device and a medical device used in an integrated system (e.g. a lancet, an IVD test strip, and a glucose meter), aspects of both this document and ISO 14155 can be considered.
- Standard72 pagesEnglish languagee-Library read for1 day
2021-11-09-JO-Following roundtable discussion on 2021-11-09 between EC desk officer, CCMC and CEN/TC 102, it was agreed that the assessment at ENQ will be performed by the Medical Device EC desk officer for a finale assessment at Enquiry. If positive, CEN/TC 102 may decide to skip the Formal Vote and proceed to publication.
- Amendment33 pagesEnglish languagee-Library read for1 day
2021-11-09-JO-Following roundtable discussion on 2021-11-09 between EC desk officer, CCMC and CEN/TC 102, it was agreed that the assessment at ENQ will be performed by the Medical Device EC desk officer for a finale assessment at Enquiry. If positive, CEN/TC 102 may decide to skip the Formal Vote and proceed to publication.
- Amendment23 pagesEnglish languagee-Library read for1 day
2021-11-09-JO-Following roundtable discussion on 2021-11-09 between EC desk officer, CCMC and CEN/TC 102, it was agreed that the assessment at ENQ will be performed by the Medical Device EC desk officer for a finale assessment at Enquiry. If positive, CEN/TC 102 may decide to skip the Formal Vote and proceed to publication.
- Amendment23 pagesEnglish languagee-Library read for1 day
2021-11-09-JO-Following roundtable discussion on 2021-11-09 between EC desk officer, CCMC and CEN/TC 102, it was agreed that the assessment at ENQ will be performed by the Medical Device EC desk officer for a finale assessment at Enquiry. If positive, CEN/TC 102 may decide to skip the Formal Vote and proceed to publication.
- Amendment33 pagesEnglish languagee-Library read for1 day
2022-06-21 - lack of compliance - publication on hold
- Amendment13 pagesEnglish languagee-Library read for1 day
2022-06-21 - lack of compliance - publication on hold
- Amendment13 pagesEnglish languagee-Library read for1 day
This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.
It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized.
It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.
- Amendment11 pagesEnglish languagee-Library read for1 day
This document specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.
It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized.
It does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.
It does not describe a quality assurance system for control of all stages of manufacture.
It does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation of the item to the site of reprocessing or disposal.
- Amendment11 pagesEnglish languagee-Library read for1 day
The scope of the Amendment is the same as EN 61010-2-101:2017. It applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes.
- Amendment17 pagesEnglish languagee-Library read for1 day
NEW!IEC 61010-2-101:2018 is available as IEC 61010-2-101:2018 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.
IEC 61010-2-101:2018 applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes. It has the status of a group safety publication, as specified in IEC Guide 104. This document has been prepared in close collaboration with Working Group CENELEC BTTF 88.1. This third edition cancels and replaces the second edition published in 2015. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:
- adaptation of changes introduced by Amendment 1 of IEC 61010-1;
- added tolerance for stability of AC voltage test equipment to Clause 6.
This Part 2-101 is intended to be used in conjunction with IEC 61010-1. It was established on the basis of the third edition (2010) and its Amendment 1 (2016).
- Standard19 pagesEnglish languagee-Library read for1 day
2022-01-13 - TC decision is missing to skip FV - publication on hold.
- Amendment15 pagesEnglish languagee-Library read for1 day
NEW!IEC 61010-2-101:2018 is available as IEC 61010-2-101:2018 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 61010-2-101:2018 applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes. It has the status of a group safety publication, as specified in IEC Guide 104. This document has been prepared in close collaboration with Working Group CENELEC BTTF 88.1. This third edition cancels and replaces the second edition published in 2015. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: - adaptation of changes introduced by Amendment 1 of IEC 61010-1; - added tolerance for stability of AC voltage test equipment to Clause 6. This Part 2-101 is intended to be used in conjunction with IEC 61010-1. It was established on the basis of the third edition (2010) and its Amendment 1 (2016).
- Standard19 pagesEnglish languagee-Library read for1 day
The scope of the Amendment is the same as EN 61010-2-101:2017. It applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes.
- Amendment17 pagesEnglish languagee-Library read for1 day
This document specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.
It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized.
It does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.
It does not describe a quality assurance system for control of all stages of manufacture.
It does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation of the item to the site of reprocessing or disposal.
- Amendment11 pagesEnglish languagee-Library read for1 day
This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.
It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized.
It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.
- Amendment11 pagesEnglish languagee-Library read for1 day
This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process described in this document intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
The requirements of this document are applicable to all phases of the life cycle of a medical device. The process described in this document applies to risks associated with a medical device, such as risks related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability.
The process described in this document can also be applied to products that are not necessarily medical devices in some jurisdictions and can also be used by others involved in the medical device life cycle.
This document does not apply to:
— decisions on the use of a medical device in the context of any particular clinical procedure; or
— business risk management.
This document requires manufacturers to establish objective criteria for risk acceptability but does not specify acceptable risk levels.
Risk management can be an integral part of a quality management system. However, this document does not require the manufacturer to have a quality management system in place.
NOTE Guidance on the application of this document can be found in ISO/TR 24971[9].
- Amendment9 pagesEnglish languagee-Library read for1 day
Frequently Asked Questions
An EU Regulation is a binding legislative act that must be applied in its entirety across the European Union. Unlike directives, regulations do not need to be transposed into national law and are directly applicable in all member states. Regulations are used when uniform application across all EU countries is essential.
Regulation 2017/746 covers "Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU". This legislation has harmonized European standards (hENs) that provide a presumption of conformity with its essential requirements. There are 106 standards associated with this regulation.
Harmonized standards under 2017/746 are European standards (ENs) developed by CEN, CENELEC, or ETSI in response to a mandate from the European Commission. When these standards are cited in the Official Journal of the European Union, products manufactured in conformity with them benefit from a presumption of conformity with the essential requirements of 2017/746, facilitating CE marking and free movement within the European Economic Area.