Re: Medical Device Accredited Warehouse in the EU
Hello and welcome to the cove
I am looking for a list of warehouses in the EU that can handle pick and pack operations for medical devices.
I assume that you refer to warehouses providing logistic services -- namely, receiving packaged and labeled goods, storage and re-distribution (secondary packaging and shipment) -- without being involved in the primary packaging and labeling of the medical devices. Is that correct? In that sense any well-organised warehouse that applies Good Distribution Practices would do, though knowledge of and sensitivity to the unique characteristics of medical devices supply in general, and the specific ones that relate to the type of devices at stake (e.g. is it temperature sensitive? does it have limited shelf life? etc.) would be a bonus of course.
What is the licensing body that accredits warehouses for medical device handling?
I'm not aware of the existence of such dedicated body. I tend to think the relevant bodies would be ISO 9xxx registrars.
Do they just need ISO 13485 or are there other licenses they would require?
If they don't pack and/or label medical devices (primary packaging and labeling) then I reckon they don't need ISO 13485 or any other medical devices related "license". I would, however, expect them to implement all relevant medical device storage, distribution and post-marketing activities that are mentioned in the MDD and ISO 13485. That would apply through your contract with them, not directly as a regulatory burden that they must bear.
Where would I get a list of all of these warehouses in the EU?
Sorry, I don't know of such list, but if I needed one I'd first try the official EC sites for clues. Hopefully other covers will come up with more.
Cheers,
Ronen.