Module 17 2024

03/12/2024

Particular Issues for Medical Devices

• Battery removal requirement problematic for some devices (e.g.

AIMDs)

• EU Commission opinion: • For Infectious devices: If life of battery expected to exceed life of device, no need for removability as device will become WEEE at EOL and WEEE exempts infectious devices. •

What about other types of devices? • It’s the manufactures responsibility • Device return/disposal policy*

• Field technicians (at not cost to buyer) • Disposal plans and instructions*

• Country specific legislation differences exist • Capacity labelling • Commercialisation impact- • How will you advise the company? • COSTS

24

Questions?

25

12