EU Legislation

New Regulations – European Commission (europa.eu)

Directives – European Commission (europa.eu)

The MEDDEV guidelines are harmonized in accordance with the relevant European directives and only apply to legacy devices – https://health.ec.europa.eu/document/download/c1a6aa0b-d8c8-498b-8ed4-9f3c6211896d_cs?filename=md_guidance_meddevs_0.pdf