With the production of Medical Devices there is more at play than safe economic production and trade. Because medical devices have a fundamental function in the field of healthcare and play a part in saving peoples’ lives, the regulation of this sector aims to ensure a safe trade, like for other products, but prioritises the protection and health of the patients and users of these devices. This is why the conformity assessment procedures, to ensure safe production, follow the procedures as constructed in The Medical Devices Directives. This is also why the products require different conformity assessment procedures, categorised by the risk these medical devices may impose.
Was this answer helpful?
Didn’t find what you were looking for? We are happy to help!
We take data safety serious. Read more in our Terms and Conditions.