Publications

MPP Positions and reports

MPP Publications

MPP Association statement on the AI ACT

The MPP Association welcomes the adoption of the EU artificial intelligence (AI) Act by the European Parliament on 13 March 2024.

Survey report

Navigating Regulatory Complexities for Integral and Non-Integral Drug-Device Combined Products

Position paper

Interface between the EU MDR, IVDR and CTR: Challenges in conducting clinical trials involving medicinal products with medical devices or IVDs

Paper

Paper on regulatory pathways for connected combined products, examining the challenges associated with regulatory pathways in the EU for a subset of connected combined products consisting of a medicinal product used with a delivery device with wireless connectivity to a standalone software.

Conference Report

MPP 2022 Annual Conference – ‘How combined products address health challenges’.

Learn more

Reflection Paper

Development and Regulation of Connected Combined Products: Reflections From the Medtech & Pharma Platform Association

Learn more

Conference Report

MPP 2021 Annual Conference – ‘Achieving agility to foster innovation and bring value to patients’.

Learn more

Best Practice Guide

MPP Best Practice Guide for clinical trials with integral Drug-Device Combination Products including change control and usability studies.

Learn more

Position Paper

Position paper on the legislative framework for Connected Combined Products.

Learn more

Reflection Paper

Reflection paper on regulatory uncertainties for co-packaged and cross-labelled drug-device combinations under the new Medical Device Regulation.

Learn more

White Paper

White Paper on EU regulatory and policy framework for combined products

Learn more