MHRA says EU rules are unclear on software in medical devices

04/10/2013 | Clinica (subscription required)

The U.K. Medicines and Healthcare Products Regulatory Agency announced plans to work with the European Commission to clarify how proposed rules for medical devices and in vitro diagnostics affect software. The agency also plans to work with other EU stakeholders on defining "companion diagnostics" and "near patient-testing," and on supply chain responsibilities. Stakeholders told the agency that the proposed rules lack clarity, and many objected to proposed rules allowing some reprocessing of single-use devices.

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