The Medicines & Healthcare products Regulatory Agency (MHRA) defines a medical device as any product which claims to treat or prevent disease.[i] Usually, toothpastes are considered ‘cosmetic’ products, intended only to keep the teeth clean. Some, however, are considered medical devices as they offer a specific treatment, such as sensitivity or enamel protection.
At BioMin®, we believe your patients’ oral health deserves science you can trust. That’s why we have chosen to classify BioMin® as a medical device under Medical Device Regulation (MDR), the most rigorous standard in Europe for products that impact your health.
This isn’t the easy route – but it is the route that sets the highest standard.
Here are the symbols that tell you what to look out for:
The MD logo means that a product is a registered medical device and the CE 0050 logo refers to a notified body number associated with CE marking, which indicates that a product complies with European safety, health and environmental requirements.
The true value of Medical Device Regulation
MDR is a complex process, requiring products to undergo many stages of scrutiny to ensure they are safe and effective. By volunteering to put BioMin® through this approval process, we can ensure it is of a high quality, enabling us to share the true value of the toothpaste with professionals and patients. Some of the key stages our toothpaste is undergoing as part of this process include:
Clinical evaluation
Every claim we make, from sensitivity relief to enamel protection, must be supported by robust scientific evidence and clinical studies. MDR ensures that a systematic review of the available literature is conducted, considering clinical data and benefit-risk analysis, to demonstrate the clinical performance of BioMin®.
Independent scrutiny
Our technology, safety, and performance data are reviewed by external notified bodies before we can sell our product. This independent assessment also includes inspections and audits, as well as verification that the relevant quality management system is in place.
Ongoing quality monitoring
We commit to continuous surveillance and improvement of our manufacturing, ingredients and consumer communication, ensuring every tube of BioMin® meets the same high standard year after year. This means that you can feel confident in the quality, safety, and efficacy of BioMin® when recommending it to your patients for many years to come.
Why Medical Device Regulation matters to dental professionals
Dentists and dental hygienists can recommend BioMin® with complete confidence, knowing:
- It performs exactly as claimed, with no marketing gimmicks.
- It delivers long-lasting sensitivity relief and remineralisation backed by peer-reviewed science.
- It stands apart from cosmetic toothpastes as BioMin® is proven to be clinically effective.
A higher standard for a better result
Very few toothpastes go through this level of regulation, but BioMin® does. This is because we are committed to providing your patients with more than a quick fix. We deliver real results, verified by science, and trusted by dental professionals in the UK and around the world.
Your patience while we complete our latest MDR update helps us keep that promise. The next time that you order BioMin®, you can be sure you’re using one of the most thoroughly validated sensitivity toothpastes available.With BioMin®, you can confidently say: “This works — and I know why.”
Follow the science
BioMin® F is designed to perform with excellence. Formulated with a revolutionary bioactive material, made with extra fine particles that bond to the tooth and block exposed dentinal tubules, it delivers superior protection against sensitivity. Additionally, BioMin® offers enamel strengthening and protecting properties, for the long-lasting health of patients’ teeth.
Plus, BioMin® continues to work in between brushes, neutralising acid in the mouth for 10-12 hours after use.
The science is clear. The solution is simple.
www.biomin.co.uk
Back in Stock Soon!
We are currently experiencing a temporary disruption in supply across many of our usual stockists due to regulatory processes. While this is a temporary pause, it’s a part of ensuring we meet the highest standards and continue to provide safe and trusted products to our customers.
We’re working hard behind the scenes to resolve this and will be sharing updates on our website as soon as we have a clearer timeline.
Your patience and continued support is truly appreciated.
[i] MHRA. A guide to what is a medicinal product. March 2020. Accessed Sept 25: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/872742/GN8_FINAL_10_03_2020__combined_.pdf
