As an active medical devices manufacturer, you must ensure that your product meets the relevant regulatory requirements before being placed on the market
It is critical to work with an EU Notified Body or UK Approved Body that understands the industry and has the experience to review and confirm your product’s readiness for market.
We truly understand the challenges medical devices manufacturers face in bringing compliant products to market efficiently and safely. We offer a range of flexible product review services providing you with efficient pathways to bring your product to market.
What are active medical devices?
Active medical devices are defined as any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy.
For more clarity on active devices, please refer to the Medical Device Regulation (EU MDR) 2017/745.
