Amendment to Directive 2001/83/EC (+2 more) on medical devices
This procedure establishes a unified set of rules for the safety and performance of medical devices sold in the EU. It aims to ensure that all medical equipment, from simple bandages to complex implants, meets strict quality and safety standards before reaching patients.
This affects manufacturers of medical devices, healthcare providers, and patients. It introduces stricter certification requirements and improves the tracking of devices to ensure faster responses to safety recalls.
Documents
Amendment to Directive 2001/83/EC (+2 more) on medical devices
proposal · EN · 2026-05-22
Amendment to Directive 2001/83/EC (+2 more) on medical devices
position · EN · 2026-05-22
Amendment to Directive 2001/83/EC (+2 more) on medical devices
report · EN · 2026-05-22
Amendment to Directive 2001/83/EC (+2 more) on medical devices
report · EN · 2026-05-22
Amendment to Directive 2001/83/EC (+2 more) on medical devices
proposal · EN · 2026-05-22
Amendment to Directive 2001/83/EC (+2 more) on medical devices
proposal · EN · 2026-05-22
Amendment to Directive 2001/83/EC (+2 more) on medical devices
proposal · EN · 2026-05-22