In praise of the CE marking, but medtech's worst fear is still alive
This article was originally published in RAJ Devices
The European Medicines Agency review meeting in London on 30 June passed with scarcely a mention of devices and diagnostics.
You may also be interested in...
2019 saw fewer revenue-boosting major acquisitions by top-tier medtechs. Companies that reported after the calendar year-end were the first to see the consequences of the pandemic on their annual figures.
If the tools are not in place by the end of 2020 to allow diagnostics companies to comply with the EU IVDR, the 2022 compliance deadline should be delayed, say EU notified bodies.
The MHRA has been working all hours to ensure the standalone medtech UKCA mark works operationally and procedurally in the UK as of 1 January 2021.