Active Implantable Medical Devices Directive

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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 ...

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 …

Active Implantable Technology for Medical Devices | BSI America …

https://www.bsigroup.com/en-US/medical-devices/Technologies/Active-Implantable-Medical-Devices/

AIMDs are subject to rigorous regulatory controls both pre- and post-market. The regulatory controls set out in the MDR also apply to any accessories that are used to enable the …

Guidance on medical devices, active implantable medical …

https://health.ec.europa.eu/document/download/02c5529f-5829-49dd-a204-03e340613a49_en

The Directives lay down essential requirements on safety and performance of the devices they cover, but do not prescribe any specific mandatory technical solutions for the …

Council Directive 93/42/EEC of 14 June 1993 concerning …

https://www.legislation.gov.uk/eudr/1993/42/2020-12-31

1.This Directive shall apply to medical devices and their accessories. For the purposes of this Directive, accessories shall be treated as medical devices in their …

MEDICAL DEVICES : Guidance document

https://ec.europa.eu/docsroom/documents/10278/attachments/1/translations/en/renditions/pdf

The Directive defines a manufacturer as the natural or legal personresponsible for defined manufacturing activities related to a device with aview to its being placed on the market …

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

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

the system of marketing authorization provided for in that Directive. 4. Where an active implantable medical device incorporates, as an integral part, a substance which, if used …

AIMDD – Active Implantable Medical …

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 …

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 …

Active implantable medical devices directive …

https://ce-marking.help/directive/active-implantable-medical-devices

The Active Implantable Medical Device (AIMD) Directive 90/385/EEC defines an active implantable ...

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