UK MHRA forum homes in on uncertainties over software as devices
This article was originally published in RAJ Devices
Executive Summary
Some three months after the amending medical devices legislation (Directive 2007/47/EC) came into effect in Europe, there is still a “significant lack of clarity” about what the new legislation “will really mean in practice” in relation to the oversight of software systems classified as devices1,2.
You may also be interested in...
EU Consults On What Constitutes Personal & Commercially Confidential Data In Marketing Applications
Based on their experience with dealing with requests for access to documents over the past 12 years, EU regulators have proposed updating their guideline that provides for a harmonized approach to protecting personal data and business secrets in marketing authorization applications.
Global Pharma Guidance Tracker – March 2024
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
EU Regulators Explain How To Ensure Transitioned Trials Align With CTR
Members of the EU’s Clinical Trials Coordination Group have developed harmonized requirements for updating trials that are transitioned to the Clinical Trials Information System based on a minimum set of documents.