If You Outsource Manufacturing of Your Medical Device or IVD, Who is Considered the Legal Manufacturer?
With the publication of Europe’s Medical Device Regulation (EU 2017/745) and In Vitro Diagnostic Regulation (EU 2017/746), some companies that contract manufacture or relabel devices (OBL/PBL) are wondering if they will be considered the “legal manufacturer” of the device they sell. Much of the confusion around this issue stems from the assumption that there can be only one legal manufacturer. But the MDR and IVDR make it crystal clear: one device can potentially have multiple legal manufacturers and each one […]
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