Whitepaper: New responsibilities for importers, distributors and authorized representatives for medical devices
According to the new reforms, an economic operator can be a manufacturer, an authorised representative, an importer, or a distributor
According to the new reforms, an economic operator can be a manufacturer, an authorised representative, an importer, or a distributor
The European Union’s (EU) Medical Device Regulations (MDR) entered into force in May 2017 with a 3- and 5- year transition period for medical devices (MDs) and in vitro diagnostics (IVDs), respectively. One important change introduced by the MD and IVD reform is the alignment of the requirements for ‘economic operators’ of the device supply chain with the Legislative Framework requirements listed in Decision 768/2008/EC.
This Whitepaper will discuss the new responsibilities for importers, distributors and authorized representatives for medical devices.