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Dear all,
I would like to have your opinion about Regulatory Intelligence activities concerning packaging waste.
I am working in a company supplying component under 21CFRpart820 / ISO13485 and I am wondering how to treat requirements on packaging waste like EU directive 94/62 & TPCH (formerly CONEG).
These documents contains requirements on Heavy Metal content as well as essential requirements on recycling activities.
The scope is obviously packaging items but there are some borderline cases like vials, syringes, and so one for which it's not so clear if it is or not in the scope.
I would like to benchmark on best practices from peers.
How deep did you go in these assessment? When did you consider the Regulatory job is done ?
Did you consider it to be included in your design inputs?
What are the functions that are to be included to assess the applicability of these requirements?
If you have any informative website or guidelines that might be helpfull, it would be really appreciated.
Many thanks in advance for sharing your knowledge,
Best regards,