It stands for Conformité Européene, literally European Conformity, meaning that the product satisfies the legislative requirements to be sold within the European Community, and that the manufacturer has checked that the product complies with all relevant essential requirements.
One of the categories covered by CE marking is medical devices for products that provide medical benefits. Toothpastes split into two categories: those with purely cosmetic function to clean and protect the tooth surface, and those with medical claims such as relief of dentine hypersensitivity. Only the latter undergo the third party scrutiny of a Notified Body as medical devices and may include the CE mark on their packaging. Their evaluation undertakes the following process:
Medical devices are classified according to their risk to the consumer. Toothpastes with medical claims, like most dental materials used in the mouth, are Class II devices and if recommended to be used on a daily basis/ long term contact are in the subgroup B. If the product has gone through this process, a unique four-digit number is added next to the CE mark on the packaging, identifying the Notified Body that has carried out the assessment. Because of the medical function of BioMin F, and the fact that it is used on a daily basis, BioMin Technologies has registered its sensitivity relief toothpastes as Class IIB devices.
BioMin® toothpastes, developed by scientists at Queen Mary University London, have an impressive dossier of research from around the world, demonstrating their effectiveness, and the company was keen to be able to make public those claims – specifically for the product’s action against dentine hypersensitivity. Richard Whatley, Chief Executive Officer, commented:
‘We were delighted that NSAI has reviewed and approved all of our technical and safety data and concluded that our product claims are based on sound scientific and clinical research and that our products meet all of the safety standards for our customers’.
Applying for CE accreditation by a Notified Body is a huge process and one which is becoming increasingly complex. It involves not only proving the product’s scientific and clinical claims, but also an extensive audit of the manufacturer’s quality management system. The company must demonstrate that it is well run and complies with the European requirements of ISO 13485. Documentation must be supplied covering all aspects of product design and specification, manufacturing, testing, justification for the claims, packaging, etc. In order to navigate the complex demands of CE accreditation, BioMin Technologies appointed Paul Rowden of European Device Solutions UK, a consultant with almost 30 years’ experience of quality management and certification processes, to assist in writing the documentation, compiling the evidence and making sure that the application would satisfy the audit.
The Notified Body that has approved BioMin’s CE marking is the National Standards Association of Ireland (NSAI), and it’s been an exacting process, taking months of very intense scrutiny. Paul commented: ‘This has been a very long haul and at considerable expense to the company with the requirement for further third party studies regarding toxicology, cytotoxicity and biocompatibility’.
However, he feels all the hard work has been worthwhile.
‘This is a mark of safety and effectiveness. It is unlikely that any other toothpaste has received the level of scrutiny that BioMin has gone through. It can prove it’s the best in its category,’
said Paul. ‘BioMin is now in an enviable position – toothpastes typically fall within the rules for cosmetic products, but we made the additional medical claims for dentine hypersensitivity and they have been upheld’.
The British Dental Industry Association recognises the huge effort put in by BioMin Technologies to get certification for its toothpastes. ‘By registering BioMin as a medical device, it puts it in a completely different league from other toothpastes,’ said BDIA Chief Executive Edmund Proffitt. ‘By going through the expense of certification BioMin is able to make claims that are independently scrutinised and justified by a Notified Body. In simple terms it allows BioMin to make much more robust claims than other toothpastes. It’s a USP (unique selling point) for BioMin F, and by going down the route of certification BioMin Technologies has reinforced its product’s credentials.’
The CE mark accreditation is recognised not only within Europe but, says consultant Paul Rowden, ‘it has massive credibility worldwide, as other countries know how much the process involves’. In addition, BioMin has recently achieved FDA 510K approval in the United States. It has also been granted approval by the Australian TGA (Therapeutic Goods Administration). In a nutshell, BioMin toothpastes have a high level, independent, international stamps of approval. It means that when you use BioMin toothpastes you can be confident that it really ‘does what it says on the tin!’