Module 3 - Strategic case studies in practice

Guideline on the quality requirements for drug-device 11 combinations 12 Table of contents 13 Executive summary ..................................................................................... 3 14 1. Introduction (background)...................................................................... 3 15 2. Scope....................................................................................................... 4 16 3. Legal basis .............................................................................................. 5 17 4. General considerations ............................................................................ 5 18 4.1. Application of Standards........................................................................................6 19 4.2. Submission of data, its location in the dossier and its format .....................................6 20 4.3. Platform technology/technologies ...........................................................................6 21 4.4. Scientific advice ...................................................................................................7 22 5. Integral DDCs .......................................................................................... 7 23 5.1. Module 1, Product Information ...............................................................................7 24 5.2. Module 3.2.P, Drug Product ...................................................................................8 25 5.3. Module 3.2.A.2, Adventitious Safety Evaluation...................................................... 12 26 5.4. Module 3.2.R, Regional Information, Medical Device ............................................... 12 27 6. Non-Integral DDCs ................................................................................ 14 28 6.1. Non-Integral DDCs with co-packed medical devices ................................................ 14 29 6.1.1. Module 1, Product Information .......................................................................... 14 30 6.1.2. Module 3.2.P, Drug Product .............................................................................. 15 31 6.1.3. Module 3.2.A.2, Adventitious Safety Evaluation ................................................... 16 32 6.1.4. Module 3.2.R, Regional Information, Medical Device ............................................. 17 33 6.2. Non-Integral DDCs with separately obtained devices .............................................. 17 34 7. Bridging to devices used in clinical development................................... 18 35 8. Lifecycle Management ........................................................................... 18 36 9. Emerging Technologies.......................................................................... 19 37 10. Definitions ........................................................................................... 20 38 Abbreviations ............................................................................................ 22 39 Annex 1: Proposal for Notified Body Opinion template .............................. 23 40 Annex 2: Template cover sheet for Notified Body Opinion......................... 26 41

Guideline on the quality requirements for drug-device combinations

EMA/CHMP/QWP/BWP/259165/2019

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