Best Practice Guide

Basel, 14 December 2020

The Medtech & Pharma Platform Association (MPP) is proud to announce the publication of the “MPP Best Practice Guide for clinical trials with integral Drug-Device Combination Products including change control and usability studies”.

The objective of this guide is to present the current best practice of Medtech & Pharma Platform (MPP) Association member companies and provide some recommendations on usability and clinical evidence from integral Drug-Device Combinations (DDC) clinical trials to support the assessment of the General Safety and Performance Requirements (GSPRs) and benefit-risk ratio determination. This topic is of particular importance under the new Medical Devices Regulation (MDR, EU 2017/745) since it impacts the evidence to be presented in support of a Notified Body Opinion (NBOp) and preparation of Marketing Authorisation Application (MAA).