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EUR-Lex - 32017R0746 - EN - EUR-Lex - Europa
- https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0746
- ‘ in vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer …
EUR-Lex - 31998L0079 - EN - EUR-Lex - Europa
- https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:31998L0079
- (b) 'in vitro diagnostic medical device` means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or …
MDCG 2022-10 - Public Health
- https://health.ec.europa.eu/system/files/2022-05/mdcg_2022-10_en.pdf
- published on EudraLex vol. 10. In vitro diagnostic medical device (IVD) is a medical device as defined in point (1) of Article 2 of Regulation (EU) 2017/745 on medical devices and, …
IN VITRO DIAGNOSTIC MEDICAL DEVICES - Tuv Sud
- https://de-mdr-ivdr.tuvsud.com/Article-10-General-obligations-of-manufacturers-IVDR.html
- Article 10: General obligations of manufacturers. 1. When placing their devices on the market or putting them into service, manufacturers shall ensure that they have …
Overview of IVD Regulation | FDA
- https://www.fda.gov/medical-devices/ivd-regulatory-assistance/overview-ivd-regulation
- What is an in vitro diagnostic product (IVD)? Definition: In vitro diagnostic products are those reagents, instruments, and systems intended for use in diagnosis of …
DocsRoom - European Commission
- https://ec.europa.eu/docsroom/documents/10294/attachments/1/translations
- Form for the registration of manufacturers and devices In Vitro Diagnostic Medical Device Directive, Article 10. Download native rendition (213.0) Download PDF …
Annex I: General safety and performance requirements
- https://de-mdr-ivdr.tuvsud.com/Annex-I-General-safety-and-performance-requirements-IVDR.html
- IN VITRO DIAGNOSTIC MEDICAL DEVICES MDR IVDR In Vitro Diagnostic Medical Devices Directive (IVDR) Recitals Chapter I: Introductory provisions Chapter II: Making …
Art. 10 In Vitro Diagnostic Regulation - General …
- https://lexparency.org/eu/32017R0746/ART_10/
- Art. 10 In Vitro Diagnostic Regulation - General obligations of manufacturers Article 10 — General obligations of manufacturers When placing their devices on the market or …
Directive 98/79/EC of the European Parliament and of …
- https://www.legislation.gov.uk/eudr/1998/79
- “ in vitro diagnostic medical device” means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, …
Directive 98/79/EC of the European Parliament and of …
- https://www.legislation.gov.uk/eudr/1998/79/contents
- Article 10. Registration of manufacturers and devices. Article 11. Vigilance procedure. Article 12. European databank. Article 13. Where a Member State considers, in relation to …
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