With the date of application of the new EU regulations on packaging and packaging waste just around the corner, I'm curious how other medical device companies are addressing this. The part about non-contact sensitive (and not single use plastic beverage bottle) packaging requirements is clear enough. It needs to be comprised of 35% recycled content by 1 January 2030 and 65% recycled content by 1 January 2040. The packaging itself must also be recyclable. Methods of conformity are documented in the technical documentation and compliance is self-declared via the declaration of conformity which is already being issued for MDD/MDR. There are some caveats obviously, but this was my general interpretation of the regulations.
Where I'm less sure, is the producer responsibilities. As a non-EU based medical device manufacturer, it seems my company needs an authorized representative. Is this EU-REP different from my normal EU-REP or can I expect a contract amendment in the near future from my current EU-REP? Also, I'm completely lost at tracking responsibilities and extended producer responsibilities so any light anyone can shed on that would be greatly appreciated.
Where I'm less sure, is the producer responsibilities. As a non-EU based medical device manufacturer, it seems my company needs an authorized representative. Is this EU-REP different from my normal EU-REP or can I expect a contract amendment in the near future from my current EU-REP? Also, I'm completely lost at tracking responsibilities and extended producer responsibilities so any light anyone can shed on that would be greatly appreciated.
