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In 2017, the European Union member states approved an amendment to the Medical Device Reporting (MDR) requirements which were set to be fully implemented on 26 May 2020.
Last September, our President, Brandy Chittester, and CEO, Sandra Maddock presented a webinar about the pending implementation of these requirements in order to review the purpose, impact, challenges, and strategies that should be considered when preparing for the implementation.
Topics: EU Device Regulations
The United States has asked the European Union to push back the compliance deadline for the new EU MDR requirements by three years, citing concerns that the world will lose access to the EU’s $125 million medical device market.
Topics: EU Device Regulations, MDRs
According to an article from Reuters, there is a clash brewing between medical device companies and the European Union. This comes on the heels of the highly publicized breast implant (PIP) scandal that shook Europe’s confidence in its light-touch system for regulating medical devices.
Topics: EU Device Regulations, Eucomed, PIP Incident