Regulatory Support

Working with you to help you through the journey to clearance and beyond

Your long-standing, trusted partner in high performance polymers

Helping you on your journey to commercialization

European Union Medical Device Regulation (MDR)

Compliance with PEEK-OPTIMA™ polymer implantable devices - what does it mean for you?

Launching a PEEK-OPTIMATM HA Enhanced device, and already have a product in the market?


The FDA Special 510(k) Program is intended to facilitate the submission, review, and clearance of a change to a manufacturer’s own legally marketed predicate device (“existing device”) that is already authorized for commercial distribution through 510(k) clearance. 
Victrex Map

Expand your PEEK portfolio globally 

We’ll help you enter and evaluate new markets in the US, Europe and Asia. Our team of global regulatory affairs experts can support you to navigate regulatory pathways, provide you with supporting documents & facilitate workshops between you and authorities including the FDA and the China's National Medical Products Administration (NMPA).