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Guidance - MDCG endorsed documents and other guidance
- https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en
- The majority of documents on this page are endorsed by the Medical Device Coordination Group (MDCG) in accordance with Article 105 of the MDR and Article 99 of the IVDR. …
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 …
IV diagnostic medical devices - Internal Market, Industry ...
- https://single-market-economy.ec.europa.eu/single-market/european-standards/harmonised-standards/iv-diagnostic-medical-devices_en
- Directive repealed: Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, OJ L 331 of 7 December 1998. …
IVD Directive 98/79/EC Classification | TÜV SÜD PSB
- 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 …
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 …
In Vitro Diagnostic Directive (IVDD) 98/79/EC - Intertek
- https://www.intertek.com/medical/regulatory-requirements/ivdd/
- Obtain Regulatory Approvals for EU Market Access for IVDD 98/79/EC Ensure your in vitro diagnostic medical device meets the essential requirements of the In Vitro Diagnostic …
In vitro diagnostic medical devices: guidance on legislation
- https://www.gov.uk/government/publications/in-vitro-diagnostic-medical-devices-guidance-on-legislation
- In vitro diagnostic medical devices: guidance on legislation Guidance explaining the main features of the Medical Devices Regulations 2002 (SI 2002 No 618, …
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/
- The IVD Medical Device Directive 98/79/EC The In vitro diagnostics Medical Device Directive 98/79/EC The scope of 98/79/EC applies to IVD medical devices and …
Overview of IVD Regulation | FDA
- https://www.fda.gov/medical-devices/ivd-regulatory-assistance/overview-ivd-regulation
- What is an in vitro diagnostic product (IVD)? Definition: In vitro diagnostic products are those reagents, instruments, and systems intended for use in diagnosis of …
Directive 98/79/EC of the European Parliament and of …
- https://www.legislation.gov.uk/eudr/1998/79/contents
- 6. Requirements for medical devices connected to or equipped with an... 6.1. Devices incorporating electronic programmable systems, including software, must be designed...
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