Medical Device Regulation (MDR) ensures that medical devices on the UK market are safe and effective for patients, the public, and healthcare professionals.[i] In order to comply with MDR, products must undergo independent clinical testing, which provides evidence that they are safe and effective. Following the UK’s exit from the European Union, many medical devices which were previously covered by the EU MDD are undergoing the process of achieving MDR status in the UK.[ii] Ultimately, clinicians should feel confident that the products they recommend to their patients have undergone the appropriate testing and have evidence to support this.
Whilst toothpaste is not necessarily classified as a medical device – instead, many are considered ‘cosmetic’ – if it claims to have a medical function such as to treat or prevent a disease, or is intended to relieve sensitivity,[iii] it is considered as such and should undergo the appropriate testing to prove the claims.
Enhanced efficiency and confidence
Evidence-based dentistry aims to provide the best possible care to a patient by considering the evidence. It is regarded as the gold standard in health care delivery around the world.[iv] By focussing on the evidence, clinicians can more effectively select solutions that minimise the risks associated with treatment or preventative care. In doing so, both the patient and the clinician can rest assured that the treatment type has been scientifically assessed, and can be more easily trusted.[v] As products which have undergone the MDR process are independently clinically tested, clinicians can look to this as a reflection of their reliability.
Increased patient satisfaction
Products that promise excellent results but don’t deliver are disappointing for patients, and may lead to a negative experience, particularly if they are experiencing prolonged pain or sensitivity as a result. Instead, recommend clinically-tested products which offer predictable and repeatable results and can increase patient satisfaction. This not only helps to improve patients’ oral health, but potentially reduces pain and helps to prevent disease. In turn, this improves patients’ trust in their practitioners as they repeatedly receive successful care and treatment which meets the expectations set by their care provider.
Certainty in toothpaste recommendation
Some patients may choose their toothpaste based on price, convenience, or because they have seen an advert for it before. However, it may be insufficient for their unique needs. By recommending patients a clinically-tested and evidence-based toothpaste by brand, clinicians can ensure patients are getting the exact formula they need to protect their teeth in-between appointments. Practitioners can be sure that products subjected to MDR testing are proven to do what they claim – for example, offering caries protection, gum health, and enamel-strengthening.
For patients, this means enhanced quality of life and reduced risk of developing dental issues and ultimately more trust in the Dental professional Recommendation. Particularly for patients who are experiencing dental sensitivity, have tooth wear, or who are undergoing tooth whitening treatment, the use of a trusted toothpaste can offer preventative effects and support their overall oral health – offering a long-term defence against attack and sensitivity in the future.
BioMin® is committed to evidence-based dentistry. We’re currently updating our medical device approval to align with the latest standards, ensuring clinicians and patients can continue to trust and rely on our high-quality formula for lasting sensitivity protection. The comprehensive nature of this testing means that only a handful of toothpastes undergo MDR. Whilst this means that BioMin® is unavailable for now, the next time you order our toothpaste, you’ll receive one of the most thoroughly tested and endorsed sensitivity toothpastes on the market.
Evidence-based dentistry means you can feel confident in the products you use, and your patients will, ultimately, feel the benefit.
The science is clear. The solution is simple.
www.biomin.co.uk
Back in Stock Soon!
We are currently experiencing a temporary supply disruption for BioMin® F and BioMin® C across many of our usual stockists due to regulatory processes. This short pause allows us to maintain the highest standards of safety and quality for our products. In the meantime, BioMin® F for Kids remains widely available across stockists in the UK and EU, as well as online via Amazon, so you can continue your child’s dental care routine without interruption.
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.
Author: Alec Hilton | CEO | BioMin Technologies
[i] https://www.digitalregulations.innovation.nhs.uk/regulations-and-guidance-for-developers/all-developers-guidance/understanding-uk-mdr-2002-regulations-for-medical-devices/
[ii] https://www.gov.uk/government/publications/registration-of-reusable-or-upclassified-class-i-devices-andor-expiring-ce-certificates/registration-of-certain-medical-devices-which-are-reusable-class-i-devices-upclassified-class-i-devices-andor-reliant-on-expiredexpiring-ce-certif
[iii] https://www.asa.org.uk/advice-online/toothpaste-general.html
[iv] Nocini, Pier Francesco et al. “”Evidence-based dentistry in oral surgery: could we do better?”.” The open dentistry journal vol. 4 77-83. 16 Jul. 2010, doi:10.2174/1874210601004020077
[v] Nocini, Pier Francesco et al. “”Evidence-based dentistry in oral surgery: could we do better?”.” The open dentistry journal vol. 4 77-83. 16 Jul. 2010, doi:10.2174/1874210601004020077
