Medical devices have long been considered a loophole category for companies that wish to make a health-related promotional claim for food products. As long as the main health effect is not pharmacological (i.e., as long as a mainly physical effect can be argued), or if the effect takes place outside of the body itself (e.g., in the intestinal tract), some notified bodies in some EU countries such as Germany allowed these products to be registered as substance-based Medical Devices.

The appeal of these products is that they can make true medicinal claims, as opposed to food products that can only claim maintenance of health. This is possible because Medical Devices are not regulated as food products and as such do not fall within the scope of the Health Claims Regulation. Therefore, this route has been an attractive way to evade the occasionally restrictive regulatory environment surrounding health claims—provided the products were registered in Germany, where the interpretation of the Medical Device Directive was particularly lax.

For most other EU countries, though, Medical Devices were gloves and syringes and the like, so the notified bodies in those countries never signed off on tablets and capsules being Medical Devices, which caused a bit of confusion about the definition of a “Medical Device” in Europe.

Changing Landscape
Partly in response to that confusion, the regulatory situation of Medical Devices is now changing. From May 26, 2020, the new Medical Device Regulation (EU) 2017/745) (MDR) will be in force. Since it is a regulation and not a directive, national implementation is required to be as close to the original text as possible, allowing no room for interpretation.

While there are no radical changes from the old directive, the MDR is more strictly interpreted because of this, closing the loopholes that existed in countries such as Germany.

One change—and for some it may indeed be radical—is that probiotics are expressly excluded from being considered as Medical Devices. This closes yet another door for these ingredients being able to make health-related claims—a topic that has been covered in this column before and will doubtless be again in the future.

‘Substance-Based’ Medical Devices
Also, the MDR introduces some changes that will affect classification of some Medical Devices, the substance-based ones among them.

With the new regulation, Rule 21 was introduced for substance-based Medical Devices. According to this rule, devices that are composed of substances, or of combinations of substances, intended to be introduced into the human body—via an orifice or applied to the skin and absorbed, or locally dispersed in the human body—are classified as class III or class IIa and IIb, respectively.

This means that previously self-classified products that conform to this description will need to be upgraded to a higher-risk class by May 26, 2020; otherwise they can no longer be marketed.
Broadly speaking, every substance-based device will be affected. Even simple nose sprays containing nothing more than a saline solution, or lozenges that only exert their effect in the mouth cavity will need to be upgraded to class IIa, with the involvement of a notified body.

Manufacturers of Medical Devices should assess whether their devices are subject to reclassification and be aware of the requirements for the new class (at least class IIa) for substance-based devices. Since class II has other requirements than class I, the Technical Documentation may need to be updated according to the new requirements.

If the Medical Device in question now falls into the higher risk classes IIb or even III, some more groundwork will be required. Clinical trials according to ISA 14155, and biocompatibility testing according to ISO 10993, may need to be performed.

Also, a drug authority may need to be consulted in case the intended action of the product is assisted by a pharmacologically active substance. Experienced consultancies such as analyze & realize GmbH will be able to assist with this upgrade.

There may, however, be cases when the product will no longer be marketable as a Medical Device at all (e.g., if it contains probiotics, or if due to its nature it seems unlikely that a notified body will register the product as such in view of the stricter interpretation of the regulations). In these cases, a strategic decision is required.

For many substance-based Medical Devices, a viable option to remain on the market is to re-launch as a food supplement, albeit at the expense of the attractive medicinal claims that are possible for Medical Devices. The pros and cons of such a decision should be considered carefully.

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Joerg Gruenwald
analyze & realize ag

Dr. Joerg Gruenwald is co-founder of analyze & realize GmbH, a specialized business consulting company and CRO in the fields of nutraceuticals, dietary supplements, herbals and functional food, and author of the PDR for Herbal Medicines. He can be reached at analyze & realize GmbH, Waldseeweg 6, 13467 Berlin, Germany; +49-30-40008100; E-mail: jgruenwald@a-r.com;
Website: www.analyze-realize.com.