Directive 90 385 Eec Concerning Active Implantable Medical Devices Aimdd

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Safe active implantable medical devices - Europa

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

Directive 90/385/EEC on the approximation of the laws relating to active implantable medical devices. WHAT IS THE AIM OF THE DIRECTIVE? As part of the European Union (EU) regulatory framework on medical devices*, it seeks to harmonise national legislation on active implantable medical devices*. … See more

Active implantable medical devices - Internal Market, Industry ...

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

Directive 90/385/EEC. Short name: Active Implantable Medical Devices. Base: Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member …

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 …

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

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

Whereas, in order to facilitate proof of conformity with these essential requirements and to permit monitoring of that conformity, it is desirable to have Europe-wide harmonized …

Directive 90/385/EEC - AIMDD - Active Implantable …

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

Whereas, in order to facilitate proof of conformity with these essential requirements and to permit monitoring of that conformity, it is desirable to have Europe-wide harmonized standards in respect of the …

AIMDD – Active Implantable Medical Devices Directive

https://mdi-europa.com/ce-marking/aimdd-active-implantable-medical-devices-directive/

AIMDD – Active Implantable Medical Devices Directive. The Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) gives manufacturers the opportunity to develop their own compliance program. …

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 Active Implantable Medical Devices Directive Explained The Active Implantable Medical Devices Directive (with …

provisions for certain medical devices and in vitro diagnostic …

https://health.ec.europa.eu/system/files/2023-01/mdr_proposal.pdf

Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (OJ L 189, 20.7.1990, p. …

MDCG 2023-3 Questions and Answers on vigilance terms …

https://health.ec.europa.eu/system/files/2023-02/mdcg_2023-3_en_0.pdf

Please note that the MEDDEV 2.12/1 rev. 8, January 2013 was in operation under the Directives (Directive 93/42/EEC concerning medical devices (MDD) and Directive …

DIRECTIVE (90/385/EEC) IMPLANTABLE MEDICAL …

https://da4284glbbt4.cloudfront.net/OJ/OLD/active-implantable-medical-devices/Active%20MDD%20OJ%202017-11-17.pdf

Commission communication in the framework of the implementation of Council Directive 90/385/ EEC on the approximation of the laws of the Member States relating to active …

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