Medical Devices are regulated by three European Union Directives.
Medical Device Regulation
The regulation of medical devices is a significant part of our work. Our principle focus are the Medical Device Directives (Regulations).
We have a small, expert team whose knowledge and skills are complemented by our members’ involvement in various relevant ABHI groups. The groups are generally open to all members, although some restrictions do apply in certain cases.
Further information is available on:
Clinical investigations are a key feature of the Medical Devices Directive.