Regulatory requirements for devices.
Medical Device Regulation
The regulation of medical devices is a significant part of our work. Our principal focus is the continued monitoring, lobbying and interpretation of legislation.
ABHI continually monitors regulatory developments by utilising strong networks within government, notified bodies and other relevant stakeholders. This intelligence is critical to ensuring that regulatory information can be supplied directly to Member companies in ’real-time’, enabling the timely development of product strategies.
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.