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EUR-Lex - l21010c - EN - EUR-Lex - Europa
- https://eur-lex.europa.eu/EN/legal-content/summary/in-vitro-diagnostic-medical-devices.html
- Directive 98/79/EC on in vitro diagnostic medical devices. SUMMARY The directive aims to guarantee the smooth operation of the single market by harmonising different national legislation on the reliability of in vitro diagnostic devices*. It provides a high level of protection for the health and safety of patients… 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 …
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 …
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 …
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
- UNDERSTANDING THE IN VITRO DIAGNOSTIC REGULATION (IVDR) The IVDR is the current regulatory basis for placing on the market, making available and putting into …
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 …
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 …
DIRECTIVE (98/79/EC) DIAGNOSTIC MEDICAL DEVICES …
- https://da4284glbbt4.cloudfront.net/OJ/OLD/in-vitro-diagnostic-medical-devices/VITRO%20OJ%202017-11-17.pdf
- Commission communication in the framework of the implementation of the Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic medical …
The IVD Medical Device Directive 98/79/EC - Ce Mark Medical
- https://www.ce-mark-medical.com/knowledgebase/the-ivd-medical-device-directive-98-79-ec/
- Article 1 of 98/79/EC gives the legal definitions which confirm that IVDs are a specific category of medical devices with particular differences and are therefore controlled …
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