There have been some really interesting innovations in the use of plants and medical devices. PlantTec’s, novel surgical application called DryField is made from micro particles of absorbable starch powder. The hydrophilic (water loving) starch helps soak up bleed outs and prevents adhesion during surgery (1). Israeli firm, Collplant sell a range of plant collagen products for wound management, their device, Vergenix creates a plant collagen matrix for optimum wound healing (2). Recent research into cellulose crystals from plants and trees shows potential for super strong lightweight biomaterials, that could be used to construct medical devices in the future (3).
In EU law, medical devices fall into differing classes, Class I medical devices must be registered with the competent national authority, but other classes can be verified and accredited by third party organisations (notified bodies). These bodies provide certification services for compliance with the Medical Device Directive 93/42/EEC and the product can then be CE marked. Popular fat binding slimming products, such as; Omega Pharma’s XLS Medical (Nopal cactus) and Kytozyme’s SlimMed and Slimforte (Chitosan) are both class IIa medical devices. In EU law a medical device ‘can modify the physiological process, as long as it does not achieve its principal intended action in the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means’. XLS medical and SlimMed both bind fat in the stomach for ready excretion before the fat is actually metabolised, therefor they fit medical device classification.
In this sector, some competitors view ingestible botanical medical devices to have an unfair advantage in terms of permissible marketing claims. Especially when the botanical in question has previously been non-authorised by the EFSA under the Nutrition and Health claim regulations. For the European Commission (EC) the issue is whether the clinical evidence is robust enough and they are actively communicating with notified bodies to ensure this. The other issue is whether the product is actually correctly defined in law. The problem is that legal definitions of what exactly is a; cosmetic, food supplement, medicine or Medical device, are not always a neat fit, making them ‘borderline’ products. At present under the medical device directive, a manufacturer can define their product. However the EC have draft amendments in the pipeline to ensure such borderline products are assessed on a case by case basis by the EC themselves. They did also suggest reinforcing clinical evidence requirements and potentially changing products that can be ingested, absorbed and dispersed by the human body into a higher risk class of medical device, however this was rejected in a vote in Oct 2013 (5). The likelihood is that the classification and clinical evidence requirements for medical devices, will eventually tighten up any loopholes. In the meantime manufacturers should make ensure the classification and clinical evidence behind their ingestible medical devices is rock solid, so they can weather any potential changes in EU law. Need advice on botanicals and medical devices? Get in touch.