Safety of medical devices

The design of medical devices must consider the safety of users and third parties, as well as that of the patient. Medical devices often constitute work equipment and are therefore also an issue for occupational safety and health.

In the European Single Market, the nature of medical devices is governed by the EU Medical Devices Regulation (EU) 2017/745. The essential requirements set out in this European product regulation are intended to protect the safety and health of patients, users and third parties. The essential requirements can be supported in standards. KAN's work focuses on the safety and health of users of medical devices, in particular the following aspects:

• Ergonomic design of medical devices from the occupational safety and health perspective (see Module 7 of KAN's ergonomics tuition modules)
• Safety aspects in product standards for medical devices