With the release of the Medical Device Regulation (MDR) 2017/745 the Medicinal Product Directive in the EU has been revised and significant changes for medicinal products that include a device constituent part (e.g. pre-filled syringes, autoinjectors and inhalers) were introduced.
Especially the MDR Article 117 has amended the Medicinal Product Directive 2001/83/EC radically.
What are the changes under MDR and which issues may occur as a result? And how do Notified Bodies interpret this Article 117?
Dr. Michael Gschwandtner, our proven expert in this field, has asked 11 Notified Bodies to get an opinion how this would work. Within his article (click HERE for download) he briefly outlines the changes and the expected impact for your combination product.
Do you need any advise or assistance e.g. for your pre-filled syringe or on-body device project?