Active implantable medical devices

Directive 90/385/EEC aims to protect the human health and safety, smooth operation of the single market and to achieve the results for which the active implantable medical devices are intended.

The devices must not present risk to patients, medical personnel or others in contact with them. Every device must bear standard information, where possible by using recognised symbols, on its sterile pack and sales packaging.

Legal acts repealed by Regulation (EU) 2017/745:

Directive 90/385/EEC (Partial repeal from 26/05/2020)

Directive 93/42/EEC (Partial repeal from 26/05/2020, See: Medical devices)

Legal acts repealed by Directive 90/385/EEC:

Directive 82/130/EEC

Directive 79/196/EEC (as at last amended by Directive 90/487/EEC)

Directive 76/117/EEC

Previous guidelines:

Guidelines on Medical Devices - Guidelines for competent authorities for making a validation/assessment of a clinical investigation application under Directives 93/42/EEC and 90/385/EEC - September 2015

Guidelines on a Medical Devices vigilance system - January 2013

Additional Guidance Regarding the Vigilance System