Publications
MPP Positions and reports
MPP Publications
Position paper
Best Practice Recommendations for Transitioning from In-House Assays to CE-Marked IVDs and Companion Diagnostics in EU Medicinal-Product Development
Position paper
MPP Position on improving coherence for single integral drug-device combinations in the evolving EU legal framework
Position paper
Impact of the IVDR on the use of in-house devices by health institutions and central laboratories in clinical trials
MPP Association letter to the European Commission
The MPP Association presents perspectives on the planned targeted evaluation of the MDR and IVDR
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’.
Reflection Paper
Development and Regulation of Connected Combined Products: Reflections From the Medtech & Pharma Platform Association
Conference Report
MPP 2021 Annual Conference – ‘Achieving agility to foster innovation and bring value to patients’.
Best Practice Guide
MPP Best Practice Guide for clinical trials with integral Drug-Device Combination Products including change control and usability studies.
Position Paper
Position paper on the legislative framework for Connected Combined Products.
Reflection Paper
Reflection paper on regulatory uncertainties for co-packaged and cross-labelled drug-device combinations under the new Medical Device Regulation.
White Paper
White Paper on EU regulatory and policy framework for combined products
