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New medical device regulation in Europe

Mr. Salvatore Scalzo, Policy and Legal Officer, European Commission, introduced the new medical device regulation published this year, including implantable medical devices and in vitro diagnostic devices. Mr. Scalzo described the specific requirements and aspects of UDI system, including criteria for the issuance of the UDI and the main deadlines for UDI assignment as well as submission of the UDI data into the European Database of Medical Devices (EUDAMED).
Traceability requirements were also outlined, including:

  • Identification of stakeholders throughout the supply chain
  • Introduction of the Single Registration Number for manufacturers, authorised representatives and importers
  • Obligation to store UDIs by all stakeholders and health institutions for Class III implantable devices

To read more about this regulation, see the presentation.