Essentials of European Medical Device Regulatory Affairs

Documents - Annex XV. Chapter II

3.Clinical investigational plan

3.1general

3.1.1single identificationnumber

3.1.2sponsorand legal rep name

3.1.3principal investigatordetails. The rolesand responsibilitiesof the investigators.

3.1.4financialarrangements

3.1.5synopsis in inan official languagedeterminedby themember stateconcerned

3.2 -3.19protocol like information 4.Other information

4.1signedstatement

4.2ethiccommitteeopinions

4.3 insurancecover

4.4 informedconsent

4.5securityofpersonalinformationarrangements

4.6 technicaldocument list

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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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