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DIRECTIVE 98/79/EC OF THE EUROPEAN …
- https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:31998L0079
- in vitro diagnostic medical devices into two main product classes; whereas, since the large majority of such devices do not constitute a direct risk to patients and are used by …
In vitro diagnostic medical devices - Internal Market, Industry ...
- https://single-market-economy.ec.europa.eu/single-market/european-standards/harmonised-standards/iv-diagnostic-medical-devices_en
- Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, OJ L 331 of 7 December 1998. Applicable until 25 …
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, …
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
- As one of the world’s largest EU Notified Body for all types of medical devices covered by EU directives and regulations, TÜV SÜD Product Service is designated as a Notified …
IVD Directive 98/79/EC Classification | TÜV …
- 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 …
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 …
In Vitro Diagnostic Directive (IVDD) …
- https://www.intertek.com/medical/regulatory-requirements/ivdd/
- In Vitro Diagnostic Directive (IVDD) 98/79/EC Obtain Regulatory Approvals for EU Market Access for IVDD 98/79/EC Ensure your in vitro diagnostic medical …
5139/23, COM(23)10 EXPLANATORY MEMORANDUM FOR …
- https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1136556/230208_Annex_B_EM_February_2023_-_Transitional_Arrangements_-_OFFICIAL_SENSITIVE_-_FINAL.pdf
- transitional provisions for certain medical devices and in vitro diagnostic medical devices. Submitted by the Department of Health and Social Care on 10 February 2023. …
DIRECTIVE (98/79/EC) DIAGNOSTIC MEDICAL DEVICES …
- https://da4284glbbt4.cloudfront.net/OJ/OLD/in-vitro-diagnostic-medical-devices/VITRO%20OJ%202017-11-17.pdf
- In vitro diagnostic medical devices — Infor ma-tion supplied by the manufacturer (labelling) — Par t 2: In vitro diagnostic reagents for profes-sional use (ISO 18113 …
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 …
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