What We Do

Influencing Regulation

We are experts in regulation and help companies to understand them so patients can access HealthTech safely and quickly.

We are unique as a Trade Association in Europe as we have Notified Bodies as Professional Associate members. Notified Bodies can attend Technical Policy Group meetings helping Industry and Notified Bodies to work better together.

We interpret legislation to make it accessible, meaningful and applicable for our members. Read more

We work with regulatory authorities to define and establish regulatory frameworks that are fit for purpose in the changing HealthTech environment. Read more

More on our Influencing Regulation work:

Clinical Investigations

Unique Device Identification

Writing Standards

Decontamination & Sterilisation

Environmental Issues