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    • Market Access
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      • And more…
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      • Quality management system as a service
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      • Performance evaluation of IVDs
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      • FDA relevant documents
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December 18, 2024


Distributor requirements (that also affect the manufacturers)

By Dr. Manuela ReinholdDecember 18, 20242 Comments

The Medical Device Regulation (MDR) has significantly increased the requirements for distributors. Learn to understand these requirements to avoid multi-year custodial sentences threatened in the event of infringement. This article also considers extensive guidance issued by the Irish regulator.

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