Directive 98 79 Ec On In Vitro Diagnostic Medical Devices

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 …

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

(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 …

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

It was published in the Official Journal of the EU on 5 May 2017, and entered into force on 26 May 2017, gradually replacing the EU’s former Directive on in vitro diagnostic …

IVD Directive 98/79/EC Classification

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 …

2019 - 2024

https://www.europarl.europa.eu/doceo/document/TA-9-2023-0052_EN.pdf

on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176). 5 Council Directive 90/385/EEC of …

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 …

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

Directive 93/42/EEC on medical devices (EU MDD) Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD) longer allowed to place these medical devices …

ANNEX I Directive 98/79/EC - ESSENTIAL REQUIREMENTS

https://lexparency.org/eu/31998L0079/ANX_I/

The devices must be designed, manufactured and packed in such a way that their characteristics and performances during their intended use will not be adversely affected …