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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 system, whether used alone or in combination, intended by the manufacturer to be used in vitro …
Directive 98/79/EC of the European Parliament and of …
- https://www.legislation.gov.uk/eudr/1998/79
- (7) Whereas the major part of medical devices are covered by Council Directive 90/385/EEC of 20 June 1990 on the approximation of laws relating to active …
IVD Directive 98/79/EC Classification | TÜV SÜD PSB
- https://www.tuvsud.com/en-sg/services/testing/in-vitro-diagnostic-medical-devices-directive-9879ec
- In vitro diagnostic medical devices (IVDs) are subject to the European Directive 98/79/EC (IVDD). A subgroup of medical products, their market access, use, and market surveillance is regulated. The IVDD …
EU In Vitro Diagnostic Medical Device Regulation | TÜV …
- https://www.tuvsud.com/en/industries/healthcare-and-medical-devices/medical-devices-and-ivd/medical-device-market-approval-and-certification/eu-in-vitro-diagnostic-medical-device-regulation
- The IVDR requires device manufacturers to conduct clinical performance studies and provide evidence of safety and performance proportionate with a device’s assigned risk …
Directive 98/79/EC of the European Parliament and of …
- https://www.legislation.gov.uk/eudr/1998/79/contents
- Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices legislation.gov.uk Home Browse Legislation New …
Medical Device Classification, MDD 93/42/EEC, IVDD
- https://www.eurofins.com/industrial/industries/medical-devices/medical-device-classification/
- The In Vitro Diagnostic Medical Devices Directive 98/79/EC defines an " in vitro diagnostic medical device’ as any medical device which is a reagent, reagent …
In Vitro Diagnostic Directive (IVDD) 98/79/EC - Intertek
- https://www.intertek.com/medical/regulatory-requirements/ivdd/
- Obtain Regulatory Approvals for EU Market Access for IVDD 98/79/EC. Ensure your in vitro diagnostic medical device meets the essential requirements of the In Vitro Diagnostic Directive (IVDD), including …
European CE Marking for In Vitro Diagnostic (IVD) Medical …
- https://www.emergobyul.com/services/european-ce-marking-vitro-diagnostic-ivd-medical-devices
- CE marking indicates that an IVD device complies with the European In-Vitro Diagnostic Devices Directive (IVDD 98/79/EC) and that the device may be legally commercialized in …
The IVD Medical Device Directive 98/79/EC - Ce Mark Medical
- https://www.ce-mark-medical.com/knowledgebase/the-ivd-medical-device-directive-98-79-ec/
- The IVD Medical Device Directive 98/79/EC The In vitro diagnostics Medical Device Directive 98/79/EC The scope of 98/79/EC applies to IVD medical devices and …
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