Since the MEDDEV 2.7/1 rev4 it has been necessary to analyze the scope of the clinical evaluation in advance of the evaluation itself and with reference to the specific case. The scope must be stated in a clinical evaluation plan (CEP) (stage 0, scoping). The new Medical Device Regulation (MDR, EU 2017/745) requires a CEP as separate document.
How the clinical evaluation plan is normally set up? How the CEP is related with Clinical Development Plan and Clinical Investigation plan?
CEP design has to clarify critical points before performing the clinical evaluation. CEP specifies methods for identification and evaluation of available clinical data relevant to the device and its intended use, establishing the safety and performance of the device. CEP is of particular interest for medical devices, for which the regulatory classification with respect to equivalency and clinical data is yet to be clarified.
CEP will include: 1)The data source with a justification of the choice 2) The search strategy 3)The selection criteria used to select the relevant publications, including justification 4)The strategy applied for avoiding data bias
Are the structure and content different between MDD and MDR?
A change in device class can lead to new submission requirements including addition of essential requirements, update to Technical Files and Declaration of Conformity, and generation of clinical evidence, with all of these adding significant time and cost burden to a project.
2001-2009 Sinclair Pharmaceutical LTD, R&D and Regulatory Director
2009-2016 BMG Pharma Srl – Delife Pharma Srl Regulatory & QA Director
From 2016 Relife Srl - QA & Regulatory Manager