Parallel importation of medical devices
Nov 14, 2024 ·
7m 19s
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Description
The Importance of Article 16 of the MDR Article 16 represents a major advancement in the https://www.direnzo.biz/it/en/parallel-imports-medical-devices/, providing more clarity and detail than previous regulations. Specifically, it: - Clearly defines...
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The Importance of Article 16 of the MDR
Article 16 represents a major advancement in the regulation of parallel imports, providing more clarity and detail than previous regulations. Specifically, it:
show less
Article 16 represents a major advancement in the regulation of parallel imports, providing more clarity and detail than previous regulations. Specifically, it:
- Clearly defines what constitutes a parallel import of a medical device.
- Underscores the critical importance of adherence to essential requirements and harmonized standards.
- Imposes specific obligations on parallel importers, including verification of technical documentation and device traceability.
- Allows for corrective and safety measures to be taken in the event of non-compliance.
Information
| Author | Di Renzo Regulatory Affairs |
| Organization | Di Renzo |
| Website | - |
| Tags |
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