Guest
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?
Assign topic to the user
Expert
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/
Comment as guest or Sign in
Mar 27, 2019
Mar 27, 2019
Mar 27, 2019