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.

View Full Article in:

Clinica (subscription required)

Published in Brief:

SmartBrief Job Listings for Health Care

Job Title Company Location
Food & Drug Associate
Confidential
Washington, D.C., DC
Senior Manager, Gaps in Care
UAW Retiree Medical Benefits Trust
Detroit, MI
Compliance Director
Abbott Laboratories
Santa Clara, CA
Product Development Manager, Disposable Medical Products
ASAHI INTECC, Orange County CA R&D Center
Santa Ana, CA
Neurovascular Intervention Product Sales Rep, North East
ASAHI INTECC
Multiple Locations, SL_Multiple Locations