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Enzymatica comments on MDR certification for ColdZyme


Enzymatica comments on MDR certification for ColdZyme

20 March, 2024

Enzymatica has received CE certification for ColdZyme under the EU’s new Medical Device Regulation. According to the company, this is an important milestone that validates their scientific and regulatory foundation. Additionally, the certification provides an opportunity to expand both the intended use and product claims for ColdZyme. BioStock interviewed Ann-Christine Provoost, Director Regulatory Affairs, to find out more.

The Medical Device Regulation (MDR) is the new EU regulation for medical devices that replaces the previous regulatory framework, the Medical Device Directive (MDD).

MDR applies as of May 26th, 2021, with the aim of improving patient safety by introducing more rigorous reviews and requirements to obtain market approval in 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 notified body Eurofins has conducted a comprehensive review of the company’s quality processes and product documentation and concluded that ColdZyme meets the requirements for CE marking according to MDR.

According to Enzymatica, ColdZyme is one of the first cold and flu products to be certified under MDR. The certification is expected to play an important role in future market launches and contribute to continued growth.

Enzymatica’s CEO Claus Egstrand comments on the approval in a press release:

“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.”

Sharpening 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 treatment and alleviation of both common cold symptoms and flu-like symptoms, including sore throat.

According to the new product claims, ColdZyme can be used when experiencing symptoms or when exposed to upper respiratory tract viruses causing common 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 can shorten the duration of cold and flu-like infections if the product is used at an early stage of the infection.

Comments from Director Regulatory Affairs

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 towards customers, retailers and partners.

Ann-Christine Provoost

BioStock reached out to Ann-Christine Provoost to find out more about what the MDR certification means for Enzymatica.

Congratulations on receiving CE certification according to MDR! How much time and resources have Enzymatica invested to achieve this goal?

– Thank you so 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 show that all applicable requirements in the MDR are met.

What are the direct implications of MDR certification?

– Now that the product is certified, launch and production preparations can start. There will be a step-by-step implementation of the MDR-certified product in various local markets. When the product finally reaches the customer, the extended intended use and health claims will be included on the product’s packaging and in the instructions for use.

– Our hope is that it will be clearer when ColdZyme can be used. The common cold and flu are usually self-diagnosed due to perceived 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 labelling 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 main differences between the previous and new product claims for ColdZyme?

– The main differences are that ColdZyme’s intended use has been expanded to also include treating and alleviating flu-like symptoms, and that health claims have been expanded to include that ColdZyme protects against viruses that cause flu-like infections in the upper respiratory tract.

Finally, how can the certification contribute to Enzymatica’s market expansion and growth?

– In Europe, the MDR is the applicable legislation. This means that previously MDD-certified products cannot be placed on the market once the transition period has expired. Now partners and customers know that ColdZyme will not be phased out, as the product has been certified for the new regulation.

– Globally, there is also a harmonisation of regulations for medical devices. With the MDR, the legislation on medical devices and the requirements for necessary documentation become more uniform at an international level. This means that CE certification according to MDR also benefits market access in countries outside the EU, as the documentation required for registrations and applications becomes more similar.

The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.

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