Medical Device Directives

Medical Devices | FDA - U.S. Food and Drug Administration

https://www.fda.gov/Medical-Devices

Approvals and clearances, information on medical devices by type Digital Health Center of Excellence Cybersecurity, mobile medical apps, wireless medical devices, AI/ML in Software as a...

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 …

Guide to Medical Device Directive Compliance …

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

The Medical Devices Directive (MDD) is a European CE-Directive that is replaced by the Regulation (EU) 2017/745 . Medical Devices Directive (MDD) has a wide scope and its …

Directives - Public Health

https://health.ec.europa.eu/medical-devices-sector/directives_en

Medical Device Directives

https://www.abhi.org.uk/what-we-do/regulation/medical-device-legislation/medical-device-directives/

Medical Device Directives Medical Devices have been regulated by three European Union Directives since the early 1990’s. They cover: Active implantable medical …

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 …

Medical Device Directive (MDD)

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

There are four device classifications: – Class I – Class IIa – Class IIb – Class III. Class I devices, that are non- sterile and non-measuring, do not require a Notified Body …

B COUNCIL DIRECTIVE 93/42/EEC of 14 June …

https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:en:PDF

medical device as a general rule is governed by the present Directive and the placing on the market of the medicinal product is governed by Directive 65/65/EEC; …

List of Products Covered by the EU Medical Devices …

https://www.compliancegate.com/medical-devices-directive-product-list/

Most devices used for medical purposes are regulated by the Medical Devices Directives. However, there are some exemptions: In vitro diagnostic devices Active implantable devices Notice that such products …

EU Medical Devices Directive Guide: By Anssi Ilmari …

https://www.compliancegate.com/medical-devices-directive/

What is the Medical Devices Directive? Basically the Medical Device Directive is an EU applicable statement adopted by all member states that establishes for the manufacturer, the good practices …