The EU Safeguard Clause, The Last Ditch Measure, Is Not Being Used
This article was originally published in Clinica
In the EU, the Safeguard Clause – a key feature of all three of the medical device directives – allows authorities to remove unsafe devices from the national and European markets, or to restrict their use. But it has not been used in the last five years, neither for medical devices, nor IVDs. This has been confirmed to Clinica by sources close to the European Commission.