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Directive 98/79/EC of the European Parliament and of …
- https://eur-lex.europa.eu/legal-content/EN/LSU/?uri=CELEX%3A31998L0079
- 1. National authorities must ensure that all devices available in the EU are safe …2. The devices must meet essential safety requirements in their design and othe…3. Devices wh… See more
DIRECTIVE 98/79/EC OF THE EUROPEAN …
- https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:31998L0079
- 7.12.98 EN Official Journal of the European Communities L 331/1 I (Acts whose publication is obligatory) DIRECTIVE 98/79/EC OF THE EUROPEAN PARLIAMENT AND OF THE …
EUR-Lex - 32017R0746 - EN - EUR-Lex - Europa
- https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0746
- Directive 98/79/EC allows the Commission to adopt common technical specifications for specific categories of in vitro diagnostic medical devices. In areas where no …
Directive 98/79/EC of the European Parliament and of …
- https://www.legislation.gov.uk/eudr/1998/79
- 1.This Directive shall apply to in vitro diagnostic medical devices and their accessories. For the purposes of this Directive, accessories shall be treated as in vitro …
B …
- https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1998L0079:20031120:en:PDF
- DIRECTIVE 98/79/EC OF THE EUROPEAN PARLIAMENT ANDOFTHECOUNCIL of27October1998 onin vitro diagnosticmedicaldevices …
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 SÜD PSB
- https://www.tuvsud.com/en-sg/services/testing/in-vitro-diagnostic-medical-devices-directive-9879ec
- WHAT IS IN VITRO DIAGNOSTIC MEDICAL DEVICES DIRECTIVE (98/79/EC)? In vitro diagnostic medical devices (IVDs) are subject to the European Directive 98/79/EC (IVDD). A subgroup of medical products, …
Medical devices | European Medicines Agency
- https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices
- The Medical Devices Regulation applies since 26 May 2021. Manufacturers must comply with the Regulation when placing new medical devices on the market. It …
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...
ISO 18153:2003(en), In vitro diagnostic medical devices …
- https://www.iso.org/obp/ui/#!iso:std:31718:en
- The Directive 98/79/EC on in vitro diagnostic medical devices requires that the metrologically traceability of values assigned to calibrators and control materials be …
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