Hello all,
I am wondering if there is any regulation for retention samples of medical devices. I was looking through the MDR, MPG, MPDG (both german national law, MPDG replaced the MPG since the MDR came into force), ISO:13485, and I could not find any paragraph or hint for how to handle retention samples for medical devices. I know that the gmp has got exact requirements for pharmaceutical products and I am searching for anything that is usable for medical devices in particular.
Is it all just a question how the company set the requirements within the process?
Thanks for all replys in advance, maybe you can help me out
Greetings from Berlin,
Paul
I am wondering if there is any regulation for retention samples of medical devices. I was looking through the MDR, MPG, MPDG (both german national law, MPDG replaced the MPG since the MDR came into force), ISO:13485, and I could not find any paragraph or hint for how to handle retention samples for medical devices. I know that the gmp has got exact requirements for pharmaceutical products and I am searching for anything that is usable for medical devices in particular.
Is it all just a question how the company set the requirements within the process?
Thanks for all replys in advance, maybe you can help me out
Greetings from Berlin,
Paul