Module 18 2021

First page Table of contents Previous page 258 Next page Last page

2/9/2021

Clinical Investigations

The MDCG Groups are working on a Clinical Investigations Plan and Assessment Reporting Template (Due Spring/Summer 2021)

• Consider Compliance of CIP to ISO14155 Annex A & MDR Annex XV

Clearly Document: • Study design. • Devices identified. • Patient population. • Patient numbers. •

Objectives and endpoints.

Length of follow up and intervals.

• • •

Study locations. Overall conclusions.

Consider detailed justifications where they may be deviations.

MDCG 2020-13 encourages NBs to review all this information. MDCG 2019-9 also provides a list of detailed information in relation to reporting clinical investigations.

Data collection: comprehensive searches

• Search strategy can introduce bias through missed data if not sufficiently: • Systematic • Sensitive • Specific Both the MDD (AIMDD) and MDR require the clinical evaluation to “ follow a defined and methodologically sound procedure ”. MDR provides some specific guidance for achieving this.

MedDev 2.7/1 rev 4 provides more detail still. Literature searches should be validated and documented in sufficient detail to allow critical appraisal and reproduction of the methods used.

Made with FlippingBook flipbook maker