Adverse events, adverse device effects and device deficiencies (a) Definitions of adverse events and adverse device effects. (b) Definition of device deficiencies. (c) Definitions of serious adverse events and serious adverse device effects and, where appropriate, unanticipated serious adverse device effects. (d) Time period in which the principal investigator shall report all adverse events and device deficiencies to the sponsor and, where appropriate, to Ethics Committee and the regulatory authority. (e) Details of the process for reporting adverse events (date of the adverse event, treatment, resolution, assessment of both the seriousness and the relationship’ to the investigational medical device). (f) Details of the process for reporting device deficiencies. (g) List of foreseeable adverse events and anticipated adverse device effects, together with their likely incidence, mitigation or treatment. (h) Emergency contact details for reporting serious adverse events and serious adverse device effects.