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Importers and Distributors: When Do Manufacturers' Obligations Start? (MDR/IVDR)
When does a distributor or importer become, for all legal purposes, the MANUFACTURER of a medical device?
In this episode, we shed light on one of the most complex, sensitive, and controversial aspects of the European Regulation on Medical Devices (MDR 2017/745) and the European Regulation on In Vitro Diagnostics (IVDR 2017/746): Article 16.
If you work in logistics, distribution, import, or compliance in the MedTech sector, you can't miss this episode.
Let's analyze together:
👉 The 3 key scenarios in which the automatic change of legal role is triggered.
👉 The key exceptions (when label translation and repackaging do not alter your qualifications).
👉 The strict additional obligations for those who repackage (28-day advance notification and Quality Management System Certification).
Avoiding sanctions or customs blockades on the market requires a thorough understanding of your economic roles. Listen to the episode to find out how to protect your business!
Enjoy!
In this episode, we shed light on one of the most complex, sensitive, and controversial aspects of the European Regulation on Medical Devices (MDR 2017/745) and the European Regulation on In Vitro Diagnostics (IVDR 2017/746): Article 16.
If you work in logistics, distribution, import, or compliance in the MedTech sector, you can't miss this episode.
Let's analyze together:
👉 The 3 key scenarios in which the automatic change of legal role is triggered.
👉 The key exceptions (when label translation and repackaging do not alter your qualifications).
👉 The strict additional obligations for those who repackage (28-day advance notification and Quality Management System Certification).
Avoiding sanctions or customs blockades on the market requires a thorough understanding of your economic roles. Listen to the episode to find out how to protect your business!
Enjoy!
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By Di Renzo Regulatrory AffairsWhen does a distributor or importer become, for all legal purposes, the MANUFACTURER of a medical device?
In this episode, we shed light on one of the most complex, sensitive, and controversial aspects of the European Regulation on Medical Devices (MDR 2017/745) and the European Regulation on In Vitro Diagnostics (IVDR 2017/746): Article 16.
If you work in logistics, distribution, import, or compliance in the MedTech sector, you can't miss this episode.
Let's analyze together:
👉 The 3 key scenarios in which the automatic change of legal role is triggered.
👉 The key exceptions (when label translation and repackaging do not alter your qualifications).
👉 The strict additional obligations for those who repackage (28-day advance notification and Quality Management System Certification).
Avoiding sanctions or customs blockades on the market requires a thorough understanding of your economic roles. Listen to the episode to find out how to protect your business!
Enjoy!
In this episode, we shed light on one of the most complex, sensitive, and controversial aspects of the European Regulation on Medical Devices (MDR 2017/745) and the European Regulation on In Vitro Diagnostics (IVDR 2017/746): Article 16.
If you work in logistics, distribution, import, or compliance in the MedTech sector, you can't miss this episode.
Let's analyze together:
👉 The 3 key scenarios in which the automatic change of legal role is triggered.
👉 The key exceptions (when label translation and repackaging do not alter your qualifications).
👉 The strict additional obligations for those who repackage (28-day advance notification and Quality Management System Certification).
Avoiding sanctions or customs blockades on the market requires a thorough understanding of your economic roles. Listen to the episode to find out how to protect your business!
Enjoy!