Digital Health Legal
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Volume: 4 Issue: 4
(April 2017)

europes new medical devices regulations profound impact digital health medical devices regulation (‘mdr vitro diagnostics regulations (‘ivdr) aim

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Europe’s new medical devices regulations’ profound impact on digital health

The Medical Devices Regulation (‘MDR’) and In Vitro Diagnostics Regulations (‘IVDR’), which aim to improve the safety of medical devices for the benefit of patients while preserving timely access to innovative healthcare solutions, have been established in final text following adoption by the EU Council on 7 March 20171. Both regulations will have a profound impact on the eHealth industry because they regulate many aspects of the provision of eHealth services and the underlying devices and software. Compared to the current Medical Devices Directive (‘MDD’) and In Vitro Diagnostics Directive (‘IVDD’), the new regulations mark a quantum leap forward in the regulation of eHealth related functionality with many consequences for the industry, requiring companies that produce medical devices for eHealth to step up their regulatory game considerably. Erik Vollebregt, Partner at Axon Lawyers and member of the Digital Health Legal Editorial Board, often starts presentations and discussions concerning the regulations with the Lord of the Rings paraphrase “One does not simply walk into the MDR/IVDR,” which Erik explains in this article is not an understatement.

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