What Medical Device could you be using twice a day without realising?
Toothpaste! Seriously. Had you ever considered that toothpaste could be a medical device? This is something I hadn’t thought about until recently, after purchasing a new supply to sort out a sensitive tooth. As I inspected my investment in lasting dental relief, I noticed the ‘MD’ symbol on the packaging.
It turns out that in the UK, toothpaste can be classified as a cosmetic, medicinal product or a medical device. The MHRA’s A guide to what is a medicinal product (March 2020) states that:
Toothpastes which are intended to be used to relieve the pain of sensitive teeth will fall to be either medicinal products or medical devices depending on their mode of action. However, toothpastes which are designed to be used without exacerbating sensitivity remain as cosmetics. Classification of toothpastes as cosmetics, medicinal products or medical devices are dependent on the product’s
composition, mode of action and presentation.
There is also a guidance available on the classification of toothpaste claims, created by the Cosmetics, Toiletry and Perfumery Association (CTPA) in collaboration with the MHRA in 2018, which outlines the types of claims made for toothpastes and what this means in terms of the regulations that will apply to individual products given those claims. It is an interesting read, which considers the
potential claims associated with toothpaste, including how the MHRA prefer the term ‘freshens breath’ over ‘bad breath problems’. I’m sure that the Saatchi’s would be in agreement on the language front, but is it for the same reasons?
So, my overpriced sensitive toothpaste is indeed a medical device, because it is intended to relieve the pain of sensitive teeth, has ‘clinically proven lasting relief for 8 weeks’ and the mode of action does not allow it to fall under the medicinal products regulations.
What’s my point? Well – sarcasm aside – it got me thinking about how important the work we all do in the medical device industry is to everyday life. We all thrive and respect being part of the team brining the latest pacemaker technology, fertility device or pandemic test kit to market, knowing their critical importance to patients. But we perhaps don’t realise how much our work brings quality of life to millions of people in these smaller ways – even though most of them don’t even know we are even there. I for one am grateful that someone made sure that when I solve my sensitive tooth problem, I’m not creating any new ones!
If there is any doubt in your mind about whether your product could qualify as a medical device and needs to be compliant to medical device regulations, just get in touch with us at IMed and we’ll make sure you have the right advice, so you and your patients/customers are protected.
IMed QA/RA & MDR Consultant