Essentials of European Medical Device Regulatory Affairs

Clinical Investigations Post CE mark

• Product evaluations to support – reimbursement, – marketing (user preference data), – future development • Notification to CA not required providing product used as per label

and no extra burden for the patient (Germany) • May not require ethics approval providing:

• Product must be under normal use – no protocol driven additional procedures • Does not require patient questionnaires • Patient would have been treated with product regardless of evaluation

• Usually still requires patient consent

123

Guidance

https://ec.europa.eu/growth/sectors/medical-devices/current-directives/guidance_en

124