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Life Sciences International Review - Q2 2019

EU – REGULATORY - Brexit, Notified Bodies, and Medical Devices - The House of Commons Library published a briefing paper on June 12 on the UK’s product standards and safety marking compliance in light of Brexit. In the...more

FDA Finalizes Program for Medical Device Reporting in Summary Form for Certain Manufacturers

The US Food and Drug Administration (FDA) issued an order in the Federal Register on August 17 announcing a new “Voluntary Malfunction Summary Reporting Program.” FDA issued this order to implement certain provisions of the...more

FDA Delays eMDR System Adverse Event Codes Update

The electronic medical device reporting system adverse event code update was originally planned for deployment in April, but was delayed until July 5, 2018, to give industry more time to comply....more

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