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Does the medicinal product licence holder need to comply with ISO 13485 ?

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Guest user Created:   Mar 27, 2019 Last commented:   Mar 27, 2019

Does the medicinal product licence holder need to comply with ISO 13485 ?

If a device is considered as integral in terms of a medicinal product (art. 117 MDR) and the device element is manufactured by a contract manufacturer, does the product license holder (for the medicinal product) also have to comply with ISO 13485?
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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Verlene Law Mar 27, 2019

Answer:

As a product license holder (with no manufacturing responsibilities including primary assembly of products), you are not required to comply with ISO 13485 however your contract manufacturer has to comply with ISO 13485.

For further information, please look at the following article:
-What are the consequences of noncompliance with ISO 13485 for manufacturers of medical devices? https://advisera.com/13485academy/blog/2017/11/02/what-are-the-consequences-of-noncompliance-with-iso-13485-for-manufacturers-of-medical-devices/
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Mar 27, 2019

Mar 27, 2019