[QualitiBot] Bases de connaissances pour les DM de diagnostic in vitro
QualitiBot, assistant virtuel proposé par Qualitiso, sort de son bilan de compétences : il est apte à la pratique du dispositif médical de diagnostic in vitro.
Ainsi, les connaissances relatives aux DM-DIV, dans le contexte du règlement 2017/746, ont été ajoutées aux bases de connaissances du bot.
Mais que sont ces bases de connaissances (KB) ?
Les bases de connaissances sont utilisées par QualitiBot comme éléments de contexte ; elles intègrent des informations utiles en contexte DM : obligations, méthodes, exemples, cas borderline, etc.
Techniquement, ce sont des bases de données intégrant des informations découpées en fragments. Par rapport au texte originel, les informations sont nettoyées / optimisées / contextualisées / remises en forme / enrichies selon les besoins et le contenu du document d’origine. Les normes sont un cas particulier : les KB n’intègrent pas de citations directes, mais le bot est formé sur leurs idées et concepts.
Note: Les normes sont vraiment un cas à part, elles sont construites comme les LLM : en se basant sur la pratique constatée. Ainsi, les LLM, même lorsqu’ils n’ont pas été entraînés directement sur les textes des normes, sont tout à fait capables de proposer un contenu cohérent, uniquement en se basant sur un sommaire en accès libre.
Mais pourquoi utiliser des bases de connaissances ?
Les IA généralistes (horizontales) savent répondre quelque chose lorsqu’on les interroge sur ces thématiques. La qualité des réponses est directement liée à la place de chaque sujet dans la littérature ; les sujets de niche sont les plus susceptibles de provoquer des hallucinations.
Conscients de ce problème, les chats généralistes (ex: Chat GPT) ont tendance à aller chercher sur le net des informations qui risquent d’être indisponibles (textes privés) ou très indigestes (cf. eur-lex.europa.eu).
Travailler avec des KB met les informations nécessaires sous les yeux du bot. Avec des modèles et des tâches correctement dimensionnés, le risque d’hallucination ou d’oubli d’informations est réduit autant que possible.
Aperçu des connaissances relatives au DM-DIV actuellement intégrées au bot
Les KB intègrent l’état de l’art applicable. Elles sont régulièrement enrichies..
| EU Reg | Guidance | LIVE | Standard |
|---|---|---|---|
| European Medical Device Nomenclature (EMDN) IVDR – Language requirements for manufacturers Member States-specific national requirements for clinical investigations and performance studies Regulation (EU) 2016/679 of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation) Regulation (EU) 2017/2185 of 23 November 2017 on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the European Parliament and of the Council Regulation (EU) 2017/746 of 5 April 2017 on in vitro diagnostic medical devices Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council Regulation (EU) 2022/944 of 17 June 2022 laying down rules for the application of Regulation (EU) 2017/746 of the European Parliament and of the Council as regards the tasks of and criteria for European Union reference laboratories in the field of in vitro diagnostic medical devices (Text with EEA relevance) Regulation (EU) 2022/945 of 17 June 2022 laying down rules for the application of Regulation (EU) 2017/746 of the European Parliament and the Council with regard to fees that may be levied by EU reference laboratories in the field of in vitro diagnostic medical devices Regulation (EU) 2023/2713 of 5 December 2023 designating European Union reference laboratories in the field of in vitro diagnostic medical devices Regulation (EU) 2024/1860 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 June 2024 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices Regulation (EU) 2025/117 of 24 January 2025 laying down rules for the application of Regulation (EU) 2021/2282 with regard to the procedures for joint scientific consultations on medical devices and in vitro diagnostic medical devices Regulation (EU) 2026/977 of 4 May 2026 laying down certain uniform quality management and procedural requirements for the conformity assessment activities carried out by a notified body designated under Regulations (EU) 2017/745 and (EU) 2017/746 of the European Parliament and of the Council Regulation OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its Annex I Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology and codes | ANNEX VII – COMMISSION IMPLEMENTING Regulation DRAFT Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 Changes to companion diagnostic devices under the IVDR, Annex IX, section 5.2 that require prior approval by a notified body Code of Conduct for Notified Bodies under Regulations (EU) 2017/745 and (EU) 2017/746 EMA Questions & Answers for applicants, marketing authorisation holders of medicinal products and notified bodies with respect to the implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746) EU Overview of language requirements for manufacturers of medical devices for the information and instructions that accompany a device in a specific country EU Q&A – Gradual roll out of EUDAMED EU Q&A Obligation to inform in case of interruption or discontinuation of supply EU Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices EU Q&A on practical aspects related to the implementation of the extended transitional period provided for in the IVDR, as amended by Regulation (EU) 2024/1860 Guidance on the safe making available of medical device software (MDSW) apps on online platforms IVDR Certification Process (including Pre-application, Application and Post Application phases) – Consensus document Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices MDCG 2018-1 Guidance on basic UDI-DI and changes to UDI-DI MDCG 2018-5 UDI assignment to medical device software MDCG 2018-6 Clarifications of UDI related responsibilities in relation to Article 16 of the MDR and the IVDR MDCG 2018-7 Provisional considerations regarding language issues associated with the UDI database MDCG 2018-8 Guidance on content of the certificates, voluntary certificate transfers MDCG 2019-1 MDCG guiding principles for issuing entities rules on basic UDI-DI MDCG 2019-11 Qualification and classification of software — Regulation (EU) 2017/745 and Regulation (EU) 2017/746 MDCG 2019-13 Guidance on sampling of devices for the assessment of the technical documentation MDCG 2019-5 Registration of legacy devices in EUDAMED – obsolete MDCG 2019-7 Guidance on article 15 of the MDR and IVDR on a ‘person responsible for regulatory compliance’ MDCG 2020-1 Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software MDCG 2020-16 MDCG 2020-16 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 MDCG 2021-12 FAQ on the European Medical Device Nomenclature (EMDN) MDCG 2021-13 Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers MDCG 2021-14 MDCG 2021-14 Explanatory note on IVDR codes MDCG 2021-19 Guidance note integration of the UDI within an organisation’s quality management system MDCG 2021-22 Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies MDCG 2021-23 Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 MDCG 2021-26 Q&A on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 MDCG 2021-27 Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 MDCG 2021-4 Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746 MDCG 2021-5 Guidance on standardisation for medical devices MDCG 2022-10 Q&A on the interface between Regulation (EU) 536/2014 and Regulation (EU) 2017/746 MDCG 2022-15 MDCG 2022-15 Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR MDCG 2022-16 Guidance on Authorised Representatives Regulation (EU) 2017/745 and Regulation (EU) 2017/746 MDCG 2022-19 Performance study application/notification documents under Regulation (EU) 2017/746 MDCG 2022-2 MDCG 2022-2 Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs) MDCG 2022-20 Substantial modification of performance study under Regulation (EU) 2017/746 MDCG 2022-3 MDCG 2022-3 Verification of manufactured class D IVDs by notified bodies MDCG 2022-6 MDCG 2022-6 Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR MDCG 2022-7 Q&A on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU) 2017/746 MDCG 2022-8 Application of IVDR requirements to ‘legacy devices’ and devices placed on the market prior to 26 May 2022 under Directive 98/79/EC MDCG 2022-9 Summary of safety and performance template MDCG 2023-1 Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 MDCG 2023-2 List of Standard Fees MDCG 2023-3 Questions and Answers on vigilance terms and concepts as outlined in Regulation (EU) 2017/745 and Regulation (EU) 2017/746 MDCG 2024-1 Device Specific Vigilance Guidance (DSVG) Template MDCG 2024-11 MDCG 2024-11 Guidance on qualification of in vitro diagnostic medical devices MDCG 2024-13 Regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devices MDCG 2024-16 Manufacturer Information Form on Interruption or Discontinuation of Supply of certain medical devices and certain in vitro diagnostic medical devices MDCG 2024-4 Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746 MDCG 2025-10 Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices MDCG 2025-5 Questions & Answers regarding performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746 MDCG 2025-6 FAQ on Interplay between the MDR, IVDR and the Artificial Intelligence Act (AIA) MDCG 2025-9 Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746 MDGC 2026-4 Management of SS(C)P in EUDAMED after mandatory use MDR/IVDR revision: impact on the sector TEAM NB Position Paper on IVDR Changes to companion diagnostic devices | ANSM vigilance data base BfArM vigilance data base List of IVDR Harmonised Standards FDA vigilance data base HEATH CANADA vigilance data base HPRA vigilance data base List of published NBs fees under IVDR List of Notified Bodies under IVDR TGA vigilance data base UK vigilance data base EU : Medical Devices – In Vitro Diagnostics- Latest updates EU : Notified bodies notifications for Regulation (EU) 2017/746 Team NB : News Team NB : Documents | ISO 17511:2020 In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples ISO 18113-1:2022 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) – Part 1: Terms, definitions, and general requirements ISO 18113-2:2022 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) – Part 2: In vitro diagnostic reagents for professional use ISO 18113-3:2022 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) – Part 3: In vitro diagnostic instruments for professional use ISO 18113-4:2022 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) – Part 4: In vitro diagnostic reagents for self-testing ISO 18113-5:2022 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) – Part 5: In vitro diagnostic instruments for self-testing ISO 20916:2019 In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice ISO 23640:2011 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents |
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