Enzymatica’s mouth spray ColdZyme has secured CE-certification of Class III from Eurofins, a European-approved notified body for medical devices.
Used to treat cold and flu-like infections, ColdZyme provides a barrier that protects the oral cavity and throat. It also creates an osmotically active transient barrier that traps viruses that deactivates and inhibits their ability to bond, as well as deactivates their ability to infect cells.
It is used to treat and relieve cold and flu-like symptoms, protects against viruses that cause cold and flu-like infections of the upper respiratory tract, and shortens the duration of cold and flu-like upper respiratory tract infections if used at an early stage of the infection.
The new EU medical device regulation (MDR) aims to improve patient safety by introducing more stringent methods of assessment and market surveillance, however, it has been questioned if the extensive technical documentation requirements of the MDR are suppressing opportunities for early device development.
An open letter written by the European medical technology industry to the European Commission in September 2023 asked for a change in the current regulation. It detailed three areas for change – a more efficient and fit-for-purpose CE marking system, a system that supports innovation for medical devices and diagnostics, and a single, dedicated accountable structure to oversee and manage the regulatory system.
Class III medical devices can be exempted from mandatory clinical investigations in four instances under the new EU MDR, including where the device under evaluation is a ‘design modification’ of a device already marketed by the same manufacturer.
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By GlobalData
In the announcement accompanying the certification, Enzymatica CEO Claus Egstrand said: “This is an important milestone in the history of Enzymatica as the MDR certification validates our scientific data and creates great commercial opportunities for us.
“In addition, it increases the consumer confidence in ColdZyme, as well as opens up new markets. The certification is highly anticipated by our partners since it ensures long-term security, which will contribute to Enzymatica’s growth.”
