Essentials of European Medical Device Regulatory Affairs - June 2020

Clinical Investigation Under MDD follow ISO 14155 : 2011

Clinical Investigation of medical devices for human subjects – Good Clinical Practice

this has now been incorporated into the MDR

● Protocol ● Gather sufficient evidence to evaluate device ● Record all AEs ● Under the responsibility of a clinician ● Final report should conclude with a critical evaluation

TheOrganisation for Professionals in Regulatory Affairs

Clinical Investigation Application _MDD • Application to CA (60 day review) and to ethics committee • Key components of the application: – Investigator´s Brochure – Clinical Investigation Plan / Protocol – Assurance of conformity with Essential Requirements

– Intended device labelling – Patient information sheet – Informed consent form – Qualifications of clinical investigator – Annex 10 declaration

TheOrganisation for Professionals in 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

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