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Commission Regulation (EU) No 722/2012 of 8 …
- https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:212:0003:0012:EN:PDF
- (4) Prior to being placed on the market or put into service, active implantable medical devices and medical devices of class III in accordance with the classification rules set …
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 …
DIRECTIVE (90/385/EEC) IMPLANTABLE MEDICAL …
- https://da4284glbbt4.cloudfront.net/OJ/OLD/active-implantable-medical-devices/Active%20MDD%20OJ%202017-11-17.pdf
- OFFICIAL JOURNAL OF ACTIVE IMPLANTABLE MEDICAL DEVICES DIRECTIVE (90/385/EEC) Try it for free on: https://ce-marking.help. This Free of Charge application …
Guidance on medical devices, active implantable medical …
- https://health.ec.europa.eu/document/download/02c5529f-5829-49dd-a204-03e340613a49_en
- Active implantable medical devices are defined by Article 1 of the Directive on active implantable medical devices (90/385/EEC), In vitro diagnostic medical devices are …
This document is meant purely as a documentation …
- https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1990L0385:20071011:en:PDF
- (b) ‘active medical device’ means any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly …
2019 - 2024
- https://www.europarl.europa.eu/doceo/document/TA-9-2023-0052_EN.pdf
- Member States relating to active implantable medical devices (OJ L 189, 20.7.1990, p. 17). 6 Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L …
Active Implantable Medical Devices Directive …
- https://cemarking.net/eu-ce-marking-directives/active-implantable-medical-devices-directive/
- The Directive sets out the essential safety requirements in terms of function, sterility, material compatibility, marking, ‘user’ instructions, design documentation, and CE …
Active implantable medical devices …
- https://ce-marking.help/directive/active-implantable-medical-devices
- The Active Implantable Medical Device (AIMD) Directive 90/385/EEC defines an active implantable medical device as "any active medical device which is intended to be totally or partially …
MEDICAL DEVICES : Guidance document
- https://www.medical-device-regulation.eu/wp-content/uploads/2019/05/2_1-2___04-1994_en.pdf
- the Directive on Active Implantable Medical Devices each part belonging to such system is covered by the Directive regardless of whether such part on its own is "active", "active …
Medical Device Directive (MDD)
- https://www.medicaldevicesgroup.net/medical-device/MDD_Training_D7-1.pdf
- Class I devices, that are non-sterile and non-measuring, do not require a Notified Body (NB). All other products require NB involvement. Annex IX of the MDD defines the …
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