Annex IV (Exemptions for Medical Devices and Monitoring/Control Instruments)

Annex IV of Directive 2011/65/EU lists exemptions from restricted substance restrictions that apply exclusively to medical devices (EEE category 8) and monitoring and control instruments (EEE category 9). Annex IV exemptions exist because these sectors often require long product lifecycles, specific performance characteristics, and safety assurance levels that make substitution of restricted substances particularly difficult. As with Annex III, each Annex IV exemption is time-limited and must be renewed. The EU Commission’s July 25, 2025 list update includes Annex IV exemption status. Directive (EU) 2025/2456 also transfers Annex IV exemption applications to ECHA.

Directive 2011/65/EU, Article 5 and Annex IV; Directive (EU) 2025/2456 (December 12, 2025).

Medical device and monitoring/control instrument manufacturers may be eligible for additional exemptions under Annex IV that are not available to other EEE. This is particularly relevant for diagnostic equipment, laboratory instruments, and implantable medical devices. Companies should document which Annex IV exemption entry applies, verify expiry dates, and plan renewal applications at least 18 months in advance. Annex IV exemptions require the same rigour of technical justification as Annex III.