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EUR-Lex - 31998L0079 - EN - EUR-Lex - Europa
- https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:31998L0079
- (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 implantable medical devices (5) and Council Directive 93/42/EEC of 14 June 1993 concerning medical …
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 …
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 devices | European Medicines Agency
- https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices
- The Regulations on Medical Devices (Regulation (EU) 2017/745) and on In Vitro Diagnostic Devices (Regulation (EU) 2017/746) changed the European legal …
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 …
ANNEX III Directive 98/79/EC - EC DECLARATION OF …
- https://lexparency.org/eu/31998L0079/ANX_III/
- The EC declaration of conformity is the procedure whereby the manufacturer or his authorised representative who fulfils the obligations imposed by section 2 to 5 and …
IVD Directive 98/79/EC Classification | TÜV …
- 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 …
Guidance on medical devices, active implantable medical …
- https://health.ec.europa.eu/document/download/02c5529f-5829-49dd-a204-03e340613a49_en
- 2 Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and …
New Regulations - Public Health
- https://health.ec.europa.eu/medical-devices-sector/new-regulations_en
- The EU revised the laws governing medical devices and in vitro diagnostics to align with the developments of the sector over the last 20 years. The priority was to ensure a …
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