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Medical Device Regulation: The Gold Standard

Generally, toothpastes are considered to be a cosmetic product, with their purpose to clean the teeth only. But a small number are medical devices – offering sensitivity or enamel protection, for example. To make these claims, these toothpastes undergo rigorous regulatory processes. Medical Device Regulation (MDR) proves that they are backed by scientific evidence[i].

We’ll discuss the significance of MDR, and what it means for the toothpaste you recommend to your patients.

What is a medical device?

According to the Medicines & Healthcare products Regulatory Agency (MHRA), a medical device is any product which claims to treat or prevent disease[ii]. Toothpaste can fall into either the cosmetic or medical device category, depending on its intended action.

For example, a standard fluoride toothpaste designed to help maintain normal enamel remineralisation is considered cosmetic. However, a toothpaste that actively claims to treat sensitivity or remineralise enamel goes beyond cosmetic maintenance, these therapeutic claims imply a medical function and can therefore bring the product under medical device regulations[iii].

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. In the UK medical devices can also carry the UK CA mark which since Brexit represents the same accreditation except just for the UK.

What does medical device regulation involve?

The medical device approval process is complex, ensuring optimal patient safety and device efficacy. There are several steps that must be followed to ensure that a medical device meets high standards of quality and safety. These steps include:

Classification and intended use definition

Defining the intended medical purpose and determining the correct risk class under MDR. This classification dictates the level of oversight and the type of conformity assessment required.

Clinical evaluation and evidence dossier

A clinical evaluation report is compiled. This includes:

  • a systematic review of the available literature
  • clinical investigation data
  • benefit-risk analysis

This must demonstrate the clinical performance of the toothpaste.

Risk management and biological safety

A full ISO 14971 risk management (formulation, biocompatibility, potential adverse effects, and mitigation strategies) is performed. A toxicological risk assessment is conducted for all ingredients and finished product. Proof of compliance with ISO 10993 safety requirements (cytotoxicity, irritation, and sensitisation) is provided.

Technical documentation

A detailed technical document is created which includes:

  • the product’s formulation and manufacturing process
  • quality control specifications
  • stability and shelf-life data
  • packaging and labelling information
  • post-market surveillance plan

Notified body review and conformity assessment

The entire technical document is then submitted for independent assessment. Here it will undergo a rigorous review, which involves:

  • requests for additional data or clarifications
  • facility inspections and audits
  • verification that the quality management system (ISO 13485) is in place and effective

Declaration of conformity and CE marking

Once this stage is approved, an EU declaration of conformity is issued and the CE mark is affixed to packaging. This signals that the toothpaste is compliant with MDR and legally allowed on the market.

Ongoing post-market surveillance and vigilance

This process does not end here, ongoing surveillance is essential to ensure compliance with these high standards. This involves:

  • collecting and analysing data on product performance in the market
  • preparing periodic safety update reports
  • undergoing regular audits and re-certification to maintain MDR status[iv]

More recent changes mean that medical devices in the UK are now able to apply through a UK Approved Body, to receive a UKCA marking for a medical device[v].

What does this mean for patients?

At BioMin®, we believe your patients deserve science you can trust. That’s why we have chosen to classify BioMin® as a medical device under MDR, the most rigorous standard across Europe for products that impact your health.

Due to the comprehensive nature of testing, only a handful of toothpastes in the UK go through medical regulation. BioMin® does, because we are committed to giving you more than a quick fix. We deliver real results, verified by science, and trusted by dental professionals worldwide. We appreciate your patience while we complete our latest MDR.

Next time you order BioMin®, you can be sure you’re recommending one of the most thoroughly validated sensitivity toothpastes available. With BioMin®, you can confidently say: “This works — and I know why.”

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]   ASA. Dental: Toothpaste. Accessed Sept 25 MHRA.
[ii]  A guide to what is a medicinal product. March 2020. Accessed Sept 25
[iii]  CTPA. Guide on Common Understanding of Borderline Toothpaste Claims. Accessed Sept 25
[iv] ADERICO. How are UK medical devices approved? Accessed Sept 25
[v]  UK Gov. Med Tech Regulatory Reform: The first steps towards a new framework for medical devices in the UK. Accessed Sept 25