90 385 Eec Medical Devices

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Implantable medical devices - Internal Market, Industry ...

https://single-market-economy.ec.europa.eu/single-market/european-standards/harmonised-standards/implantable-medical-devices_en

Single market and standards European standards Harmonised Standards Active implantable medical devices Active implantable medical devices Directive 90/385/EEC The …

Council Directive 90/385/EEC of 20 June 1990 on the …

https://eur-lex.europa.eu/legal-content/EN/LSU/?uri=CELEX:31990L0385

EUR-Lex - 31990L0385 - EN - EUR-Lex - Europa

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A31990L0385

Where a device incorporates, as an integral part, a substance which, when used separately, is likely to be considered to be a medicinal product as defined in Article 1 of Directive …

GUIDELINES ON MEDICAL DEVICES CLINICAL …

https://ec.europa.eu/docsroom/documents/16477/attachments/1/translations/en/renditions/pdf

medical devices directives clinical investigation guidelines for adverse event reporting under directives 90/385/eec and 93/42/eec index 1. introduction 2. scope 3. definitions 4. …

Active Implantable Medical Devices Directive …

https://cemarking.net/eu-ce-marking-directives/active-implantable-medical-devices-directive/

The Active Implantable Medical Devices Directive (with the official reference number 90/385/EEC) applies only to active implantable devices. For a device to be classified as …

Directive 90/385/EEC - AIMDD - Active …

https://mdpharmacourses.com/90-385-eec-aimdd-active-implantable-medical-devices-directive/

(a) ‘medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any …

Council Directive 90/385/EEC

https://www.legislation.gov.uk/eudr/1990/385/adopted

Council Directive 90/385/EEC Show full title Directives originating from the EU 1990 No. 385 Table of Contents Content More Resources Previous Next Plain View Print …

Active Implantable Medical Devices Directive Explained - Euronorm

https://www.euronorm.net/content/ce-marking/directives/explanation/90-385-eec.php

Active Implantable Medical Devices Directive Explained. The Active Implantable Medical Devices Directive (with the official reference number 90/385/EEC) applies only to active …

Directive 90/385/EEC - Lexparency

https://lexparency.org/eu/31990L0385/

Directive 90/385/EEC On the approximation of the laws of the Member States relating to active implantable medical devices Recitals Article 1 Article 2 Article 3 Article 4 Article 5 …

2023: What are Legacy Devices …

https://casusconsulting.com/what-are-legacy-devices/

AIMDD 90/385/EEC devices with valid Notified Body issued AIMDD CE Marking certificates Medical device legacy devices may continue to be placed onto the …

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