Our mission is to partner with brands around the world to bring infrared technology to improve people’s lives and energize their spaces. Our commitment to achieving regulatory status is a big part of that mission, evidenced by the fact that CELLIANT® products are registered, designated or determined as Class 1 Medical Devices in 38 countries and cleared to market in 15 other countries with no regulatory compliance requirements, with more countries and regions to follow.
After the EU reissued its legislation for medical devices it was necessary for all manufacturers to reassess their medical devices to ensure compliance with the new legislation. The Hologenix regulatory team got straight to work to ensure that our products were compliant, and now we can confirm that we have met the exacting criteria for all our Class I Medical Devices.
As a Class 1 Medical Device, products containing CELLIANT have a clear beneficial application that has demonstrated therapeutic benefits to users of the product. This has enabled Hologenix to assign the CE mark to its Medical Device range of products.
Our Co-founder and CEO, Seth Casden, notes, “Our unique international regulatory status and verified claim set are without doubt an extremely significant CELLIANT advantage–one that not only underscores the effectiveness of our technology, but also provides brand partners with the ability to differentiate their brand and products in an increasingly competitive market.”
Meeting regulatory requirements is not an easy process—nor should it be. We proudly devote a lot of resources toward our regulatory status as it’s an important validation of our wellness claims and a key differentiator for both CELLIANT and our brand partners’ products.
CELLIANT’s regulatory affairs department, led by myself, Richard Braham, facilitates the achievement of CELLIANT’s regulatory goals. As a team, we’ve led CELLIANT through compliance with the stricter EU regulations and our regulatory affairs department is essential for helping our brand partners leverage CELLIANT’s regulatory advantage.
Brand partners simply need to comply with our brand guidelines, and do not have to pursue any regulations on their own. The benefits are significant. It gives a competitive advantage in the market as our regulatory status validates the science and technology behind CELLIANT, a natural blend of bioceramic minerals that absorbs body heat and reflects it back as therapeutic infrared energy. This is a benefit to the brands and a key differentiator for today’s consumers, providing a product they know is safe and that they can trust.
Further, our brand partners have access to our regulatory affairs department to help guide our partners with any questions or assistance with anything related to regulatory status. It’s all part of what we mean by having a true partnership with brands we work with.
As Julian Wolf, Product Manager with our brand partner BLACKROLL® puts it, “We see the Class 1 Medical Device designation as a major benefit when marketing our products to the consumer–it is a win-win for brands and the end user.”
Our claim set is backed by science and helps our brand partners, and their customers, know exactly what CELLIANT adds to a particular product. These claims are key differentiators for our brand partners both in the actual functioning of their product and in their product storytelling:
The following claim set can also be used for marketing purposes as long as they are always accompanied by an asterisk and the following statement: *CELLIANT® is designated as a Class 1 Medical Device in the European Union. This effect is temporary and not long-term.
For full access to the available claim set, brands must first begin a partnership with CELLIANT. Please review the article on how to start a CELLIANT partnership for more details.
The products that are now able to be registered in the EU as Class 1 Medical Devices include:
With our continued Class 1 Medical Device status in the European Union and our dedicated Regulatory Affairs Department, CELLIANT gives your brand a powerful point of differentiation with benefits and storytelling. If you’re manufacturing, or looking to manufacture, textile products in the European Union, we’d love to hear from you. Fill out the form below to get in touch with our team.
CELLIANT products under the previous legislation were Class 1 Medical Devices. The assessment under the new legislation confirms that they are compliant as a Class 1 Medical Device.
No. Our partner brands simply have to comply with our brand guidelines, which is something our brand partners must do anyway, and they can enjoy all the benefits of the compliance to Medical Device legislation in the EU which includes our approved claim set.
The CE mark is a requirement for many products, and demonstrates compliance to legislative standards that are acceptable and accepted by members of the European Union.
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