Medical Devices?

New regulatory opportunities abound for drugs and supplements in Europe.

By Joerg Gruenwald

Bringing a new natural medicinal drug product to market is a time consuming, expensive affair that re-quires a full Common Technical Document (CTD) to be submitted, complete with clinical and pre-clinical trials, toxicology studies, and safety studies, all in accordance with GLP (good laboratory practices), GCP (good clinical practices), and GMP (good manufacturing practices) regulations. Clinical effectiveness has to be proven with different studies for the different phases, and a number of bureaucratic and regulatory hurdles have to be overcome. All of this a-mounts to lots of money spent and a long time invested in the registration process.

In view of all that, it is not surprising that for many products, a less ex-pensive, less protracted alternative is increasingly being realized. These products may be creams, sprays, tablets, and other formulations that look like normal drugs and are, for the most part, applied like normal drugs, but they are not. They are medical devices—products that work on a physical or mechanical level in the human body, but are nevertheless capable of healing or eas-ing symptoms.

Applying for a medical device requires adhering to a different set of directives, conducting clinical trials geared toward proving easier functional effectiveness instead of full clinical effectiveness, undergoing quality control instead of the complete set of toxicological studies, and generally complying with quality control regulations instead of pharmocopoeias. This translates into less time and money spent on clinical trials.

In some cases, a single qualified study proving efficacy and safety might be sufficient, and sometimes a literature study may even be e-nough. The registration of an average medical device, depending on the risk class, takes less time and, because of the lessened requirements, also less money.

There are additional advantages. Once the CE (Communauté Euro-péenne) mark proving safety has been issued, a medical device may be marketed in the 25 member states of the EC—no individual applications in the various EC countries are necessary. For a drug, once a registration has been issued, multiple mutual recognition procedures have to be undertaken in order to gain access to other EC markets. Another positive, compared to medicinal products, is that the issuing parties for medical devices, the so-called Notified Bodies, may be freely chosen. They may even be private institutions, since they are service partners rather than authorities in the traditional sense. This makes the registration and subsequent marketing of a medical device much more flexible compared with the procedures necessary for medicinal products.

Medical devices can be manifold. By definition, they can be anything used in the diagnosis, prevention, supervision, treatment, or alleviation of illnesses, injuries or disabilities, including the change of anatomical construction or physiological process (i.e., conception prevention), as long as no pharmacologically or immunologically active substances are employed. This comprises a wide range of physical interaction ranging from inert substances used for coating or for binding in-gested substances, up to and including magnetic field therapy.

A medical device can be a device in the traditional sense like a magnetic resonance tomography. It can be an object needed for the treatment of ill persons like a rubber glove or a specialized hospital bed. It can be a pacemaker or an artificial joint. And it can also be a spray, cream, or otherwise topically used substance. And it is worth noting that an accompanying pharmacological effect is permissible as long as the physical effect is predominant.

One early example of this new group of medical devices in Europe is chitosan. Consisting of acetylized chitin derived from shrimp waste, chitosan theoretically acts like a magnet for lipid molecules in the digestive tract. Lipid molecules are bound to the chitosan molecule, which then is supposedly excreted from the body. It does not enter the body and therefore does not interfere with the metabolism in any way. The clinical effectiveness has been questioned in several trials, but it is still a best seller.

Another new and interesting medical device product being used for weight management is Liposinol. It uses the same principle of function as chitosan—lipid binding and forming of an indigestible compound in the digestive tract, leading to lipids being prevented from being broken down and entering the body. In clinical testing, it was significantly more effective than chitosan. The active substance in this case is a patented fiber complex of organic plant origin.

The active substances used in both of these medical devices do not interact pharmacologically or immunologically with the human body. Instead, they use purely physical principles to achieve their effects.

There are numerous other examples. GeloSitin, a nasal spray, protects the nasal mucosa from drying out by forming a protective layer over it. Myfungar, a nail polish, is applied to toenails and fights fungal infections by forming a film, which keeps infections from spreading; it even works to reducing infections by depriving them of their substrate. Nyda, a spray used for the treatment of lice infestations, acts by mechanically enveloping the lice with a substance that prevents them from breathing and thus kills them without any chemical means. Urgo is a medical device that treats small breaks in the skin by forming a semi-occlusive, water resistant film that protects the skin from further injury. Yet another nasal spray uses seawater to provide humidity.

All in all, medical devices offer a relatively uncomplicated and often less expensive alternative to registering a drug, while at the same time leaving the door open for a lot of applications. It seems that the most limiting factor at present is human ingenuity.NW