Danes offer direction on new EU device regulations

Danish medical software firm Medei ApS is offering help for vendors looking to comply with the European Union Medical Device Regulation (EU MDR).

One of the EU MDR's goals is to better regulate the increasing number of medical devices that are entering the EU's 28 member states. Also, European device firms must recertify existing devices and compliance documents to adhere to the new requirements by 2020. In vitro diagnostics devices will have until 2022 to comply.

Significant changes target clinical evaluation, postmarketing surveillance, and access to data. The EU MDR also will create a database for device manufacturers to transfer their required information.

Medei's service, "Navigating the EU MDR -- Strategies for Success," is available here.

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