Medical Device Regulation, MDR, is the new EU regulation for medical devices that replaces the previous regulations, Medical Device Directive (MDD).
The MDR came into effect on 26 May 2021 with the aim of strengthening patient safety through more rigorous review and requirements for obtaining market approval within the EU. The new regulations include stricter requirements for clinical evidence, safe design and market surveillance.
Important milestone for Enzymatica
Enzymatica has been working for a long time to obtain MDR certification for ColdZyme, the company's enzyme-based mouth spray that creates a barrier in the mouth and throat against viruses. The regulatory body Eurofins has conducted an extensive review of the company's quality processes and product documentation and concluded that ColdZyme meets the requirements for CE marking according to the MDR.
According to Enzymatica, ColdZyme is one of the first cold and flu products to be certified under the MDR. The certification is expected to play an important role for future market launches and contribute to continued growth.
Enzymatica CEO Claus Egstrand comments on the approval notice in a press release:
"This is an important milestone in Enzymatica's history. The MDR certification both demonstrates the strength of our scientific basis and creates commercial opportunities for us. The certification means increased confidence in ColdZyme among consumers and opens up new markets for us. The announcement is eagerly awaited among our partners as it ensures security for the long term, which will contribute to the company's positive development."
Sharpens product claims
The certification not only confirms ColdZyme's safety and efficacy, but also expands the product's intended use and health claims. The MDR certification includes the relief and treatment of both cold and flu-like symptoms, including sore throats.
According to the new product claims, ColdZyme can be used when experiencing symptoms or upon exposure to upper respiratory viruses that cause cold and flu-like infections. The product protects against viruses by trapping the virus and inhibiting its ability to infect cells and multiply. In addition, ColdZyme may shorten the duration of cold and flu-like infections if the product is used early in the infection.
Director Regulatory Affairs tells more
Enzymatica's Director Regulatory Affairs Ann-Christine Provoost believes that the expanded and verified health claims allow the company to communicate more clearly about ColdZyme's benefits and effects for customers, retailers and partners.
BioStock contacted Ann-Christine Provoost to find out more about what MDR certification means for Enzymatica.
Congratulations on the CE certification according to MDR! How much time and resources have you invested to achieve this goal?
– Thank you very much! Our entire team in both Sweden and Iceland has been involved in this work for the past two years. It has been a thorough review of processes and product documentation to demonstrate that all applicable requirements in the MDR are met.
What will be the direct implications of MDR certification?
– Now that the product is certified, launch and production preparations can begin. There will be a phased implementation of the MDR-certified product in the various local markets. When the product finally reaches the customer, the expanded intended use and health claims will be on the product packaging and in the instructions for use.
– Our hope is that it will be clearer when ColdZyme can be used. Colds and flu are most often self-diagnosed due to experienced symptoms. For the consumer, it is difficult to know the cause of the symptoms, as testing for pathogens is rarely done for common cold and flu-like symptoms.
– It is now clearer in the product's labeling that ColdZyme, via the protective barrier, also makes it more difficult for viruses that cause flu-like symptoms in the upper respiratory tract to reach epithelial cells in the oral cavity and throat. This inhibits the virus's ability to infect, spread and multiply.
What are the key differences between the previous and new product claims for ColdZyme?
– The most important differences are that ColdZyme's intended use has been expanded to also include treating and relieving flu-like symptoms and that health claims have been expanded to include that ColdZyme protects against viruses that cause flu-like infections of the upper respiratory tract.
Finally, how can certification contribute to Enzymatica's market expansion and growth?
– In Europe, MDR is the applicable legislation. This means that previously MDD-certified products may not be placed on the market when the transitional rules have expired. Now partners and customers know that ColdZyme will not be phased out, as the product has been certified for the new legislation that applies going forward.
– Globally, there is also a harmonisation of the regulations for medical devices. With the MDR, the legislation on medical devices and the requirements for necessary documentation will become more uniform at an international level. This means that CE certification according to the MDR also benefits market access in countries outside the EU, as the documentation required for registrations and applications is more similar.
