Medical Devices

Fat Binders

Lipomyl™ Fat Binder

Supplement Factory is extremely proud of its research and development of oral medical devices, which are available for the first time as an Own Brand Label (OBL) offering. Private label brands can now opt to use our laboratory studies to add a range of scientifically verified weight loss aids to their slimming collection.

Own Brand Label – The Regulations and Requirements

An ISO 13485 accredited medical devices manufacturer, Supplement Factory offer a full service turnkey solution for brands looking to add oral medical devices to their portfolio. We endeavour to advise on all facets of the journey, from conception, regulation and design, through to manufacture, delivery& storage, through to post-market surveillance.

Medical Devices are regulated by the MHRA (Medicines and Healthcare Products Regulatory Agency) in the UK. The ability to create and manufacture medical devices is awarded after an audit or inspection of the manufacturers technical files and QMS (Quality Management Systems). A “notified body”, authorised by the MHRA can award a scientifically proven safe device with an EC kite mark.

A medical device must pass various hurdles to be awarded with an EC mark, nut for the benefits of nutritionists reading this text, it must be noted that the oral device must not cause or create a physiological effect on the human body.

Medical Devices – The benefits

Any own brand label operating in the supplement industry will be well aware of the success of medical devices. These devices generally can carry claims that fall outside of the EFSA (European Food Safety Authority) authorised claim framework.

As such, private label medical device offerings are attractive because it allows brands to stand out from the crowd by using scientifically supported claims which are generally unique selling points versus the rest of the market.

Other Private Label Offerings

We currently offer a medical device:

• Lipomyl

Currently, only 1 ingredient can make weight loss claims under EFSA guidelines. Glucomannan Konjac, which is a fibrous root holds the following claim:

Contributes to weight loss as part of an energy restricted diet when food provides a total daily intake of 3g of glucomannan in three doses of 1g each.

If you wish to add a weight loss product that has other claims beyond this, you should look no further than own brand label medical devices.