The Medical Device Regulation (MDR), published in May 2017, marked the beginning of a transition period that for Medical Devices will end up next May 26, 2020: MDR (EU) 2017/745 “application date”.
In general, MDR and IVDR keep the same provisions with new requirements, for example the definition of the Economic Operators (Medical Devices Importers and Distributors on the EU territory) who will be in charge of precise regulatory obligations.
Which changes for Importers? Three things you absolutely need to know!
- The Importer must performs labelling controls (labelling and instructions for use) on the finished Medical Devices before placing them on the EU market, ensuring that the devices are all equipped with UDI vector (barcode or matrix code).
- The Importer should register the facility as “Importer” in the Europe EUDAMED database.
- The Importer is required to notify the Manufacturer, the Authorized Representative, and, if necessary, the Competent Authorities in case of real or potential problems about the device.
Which changes for Distributors?Here there are two peculiar obligations:
- The Distributor guarantees the device storage and transport conditions are appropriate and are in compliance withmanufacturer’s recommendations.
- Finally, the Distributor registers claims, non-conforming devices and helps with recalls.
Importers and Distributors must implement and keep up-to-dated a Quality Management System to fulfill the obligations stated in articles 13, 14 and 25 of the MDR.
Want to know more? We will send the April Thema White Paper about the brand new MDR obligations in charge of Authorized Representative, Importers and Distributors of Medical Devices and in vitro diagnostic Medical Devices.
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Thema staff offers strategic advisory services linked to the MDR (EU) 2017/745 application. Our experts are available to assist Manufacturers, Authorised Representatives, Importers, and Distributors in the strategic or corrective actions needed for market Medical Devices in compliance with the regulation.
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Thema Staff email@example.com – phone: 0542 643496.
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