Active Medical Device Directive

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Medical devices | European Medicines Agency

https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices

The Medical Devices Regulation applies since 26 May 2021. Manufacturers must comply with the Regulation when placing new medical devices on the market. It repeals Directive 93/42/EEC on medical devices and the Directive 90/385/EEC on …

Medical Device Classification, MDD 93/42/EEC, IVDD - Eurofins …

https://www.eurofins.com/industrial/industries/medical-devices/medical-device-classification/

Medical Device Directive 93/42/EEC. The Medical Device Directive 93/42/EEC defines a "Medical Device" as any instrument, apparatus, appliance, material …

Active and Non-Active Medical Devices | WO | TÜV …

https://www.tuv.com/world/en/active-und-non-active-medical-devices.html

The directive distinguishes between four risk classes (class I, class IIa, class IIb, and class III). Classification may be based on the following criteria: Duration of use. Invasiveness. …

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

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

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 States relating to active …

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 …

EUR-Lex - 31993L0042 - EN - EUR-Lex - Europa

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:31993L0042

Whereas 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 (7) is the first case of …

Guide to Medical Device Directive Compliance …

https://instrktiv.com/en/medical-device-directive/

Medical Device Directive (93/42/EEC) - Certification Guide. 28/5/2019 Ferry Vermeulen Law & Legislation. 1. What is the Medical Devices Directive. The Medical Devices Directive …

Guidance on medical devices, active implantable medical …

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

Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 context Question 1: What is a medical device, active …

Medical Device Directive (MDD)

https://www.medicaldevicesgroup.net/medical-device/MDD_Training_D7-1.pdf

Medical Device Directive (MDD) 93/42/EEC as modified by 2007/47/EC. Slide 2 of 37 Robert Packard, Consultant ... • Active Implantable Medical Devices (AIMD) 90/385/EEC …

Medical Devices Directive - Wikipedia

https://en.wikipedia.org/wiki/Medical_Devices_Directive

The Medical Device Directive (Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, OJ No L 169/1 of 1993-07-12) is intended to harmonise the laws relating …

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