Publications
MPP Positions and reports
MPP Publications
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
