Questions & Answers on the implementation of the Regulations on medical devices and in vitro diagnostic medical devices

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Table of Contents

• Table of contents 3
• 1. Combinations of medicinal products and medical devices ....................... 5 3
• 2. Integral Drug-Device Combinations ......................................................... 7 3
• 3. Medicinal products that include a medical device in the secondary packaging of the marketed medicinal product co-packaged ................... 17 3
• 4. Consultation procedure for ancillary medicinal substances in medical devices Art 18 ..................................................................................... 20 4
• 5. Consultation procedure for companion diagnostics ............................... 21 4
• 1. Combinations of medicinal products and medical devices 5
• 2. Integral Drug-Device Combinations 7
• 3. Medicinal products that include a medical device in the secondary packaging of the marketed medicinal product co- packaged 17
• 4. Consultation procedure for ancillary medicinal substances in medical devices Art 18 20
• Full package including description of the manufacturing process and the data relating to the usefulness of incorporation of the substance into the device according to section 5.2 Annex IX of the MDR 21
• Declaration from manufacturer and NB detailing which elements are changed if applicable 21
• NCA opinion from 21
• 5. Consultation procedure for companion diagnostics 21