An assessment of whether a design, manufacturing, labelling or supplier change, or a new regulation, requires notification to regulators, a new submission or other regulatory action.
Analysis Work product in the Medical electronics and medical device chips lifecycle
Changes to an authorised device can invalidate the authorisation if regulators are not told. This assessment decides what each change requires; without it, changes are made that should have been notified, or are delayed by over-cautious submissions.
The full lifecycle detail, with its charts, flows, tables and every section, is for registered members. Registration is free and takes a minute. You come back to this page afterwards.