In Vitro Diagnostic Medical Devices Directive 98 79 Ec

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, …

Directive 98/79/EC of the European Parliament and of …

https://eur-lex.europa.eu/legal-content/EN/LSU/?uri=CELEX%3A31998L0079

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 …

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, …

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 device meets the essential requirements …

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 …

Guidance on medical devices, active implantable medical …

https://health.ec.europa.eu/document/download/02c5529f-5829-49dd-a204-03e340613a49_en

Medical devices are defined by Article 1 of the Medical devices directive (93/42/EEC), Active implantable medical devices are defined by Article 1 of the Directive on active …

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

Manufacturers with previously approved devices had to demonstrate compliance with the IVDR’s new requirements by 26 May 2022, although under specific circumstances an …

Medical devices | European Medicines Agency

https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices

It repeals Directive 93/42/EEC on medical devices and the Directive 90/385/EEC on active implantable medical devices. The In Vitro Diagnostic Devices …

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 …