Medical Device Development Service (MDDS)

Formulating the intended purpose of a medical device.

Identifying medical device users and other stakeholders and eliciting their requirements. Identifying relevant regulations and standards and extracting relevant requirements from these.

Creating medical device prototypes through links with other groups within our directorate (Electronic Laboratory Service, Mechanical Engineering Service, Clinical Computing).

Planning and conducting verification activities to provide evidence that requirements have been met, to justify proceeding to clinical validation.

Identifying appropriate regulatory routes for clinical studies. Supporting the planning, preparation and conduct of clinical investigations. Preparing regulatory documentation for submission to MHRA for clinical investigations.

Providing advice on CE/UKCA-marking pathways and the evidence requirements for these.