Industry voice: In defense of nutritional medical devices in the EU

By Maikel Hendriks, CEO of Medical Brands

- Last updated on GMT

Medical Brands markets medical devices like cranberry-based I-Say in the targets women's urinary tract infection (UTI) issues
Medical Brands markets medical devices like cranberry-based I-Say in the targets women's urinary tract infection (UTI) issues

Related tags: Medical devices, European union

Since 2008 the severity of the EU’s health claim laws has seen many firms seek other routes to back claims – the EU’s medical devices legal avenue being one of them. Amsterdam-based Maikel Hendriks, the CEO of Medical Brands, examines the controversial, commercially lucrative claims pathway…

The self-care category has changed rapidly over the past two years with the large scale introduction of self-care medical devices. The regulation for self-care medical devices is not new and has been effective since July 1997.

Many products have been registered according to this regulation, for example nasal sprayers, vaginal lubricants, condoms, pregnancy tests, etc. Although some people see medical devices as a self-care loophole, it brings a new view on self-care products.

Only since December 2012 has this legal route has been discovered by manufacturers in self-care and (mis)used by several market leaders in food supplements to be able to make EFSA (European Food Safety Authority) rejected claims on their products.

Under whose authority?

One French firm launched a cranberry product that was subsequently withdrawn after 12 months after French and Dutch authorities questioned its medical devices status.

Moving in another direction, a well-known self-care medicine for heartburn successfully recently changed its status from medicine to medical device. The problem is medical device auditing companies (notifying bodies) are not aware of this rapidly changing category.

There exists no AC Nielson or Euromonitor marketing data to analyse the impact of these changes. In May 2012 Nepropharm (the Dutch OTC, health products and medical devices association) conducted a physical count and found 140 self-care medical devices present on the Dutch market.

My company Medical Brands did a survey and found more than 240 self-care medical devices in Dutch retail chains. This is the fastest growing category within self-care!

With governments continuously cutting budgets on health care, transferring the responsibility for the cost of health back to the individual, and ever-growing possibilities to gain access to health information, consumers are better informed about their health than ever before. They are searching for products that are proven to treat or even better to prevent minor illnesses.

If the products come with less side-effects than pharmaceuticals then all the better.

Maikel Hendriks: "The discussions have on occasion become confused and highlight the difficulty of understanding what self-care medical devices really are (and are not)."

Threats to medical devices

But the forces are mounting against medical devices.

On 26 September 2012, the European Commission adopted a package on innovation in health that could see EU medical devices rules changed. It is expected a draft will become available at the end of 2014, beginning of 2015.

There are diverse viewpoints among EU member states.

For example, some consider medical devices that are composed of substances intended to be ingested, inhaled or administered rectally or vaginally and that are absorbed or dispersed in the human body should be classified in the highest risk class III.

Another discussion is about the definition of a medical device and in particular the definition of ‘pharmacological mode of action’.

For medical devices the mode of action of the intended use should not primarily be pharmacological, immunological or metabolic, otherwise it is a medicine by definition.

The discussions have on occasion become confused and highlights the difficulty of understanding what self-care medical devices really are (and are not).


Borderline committee

In the actual Medical Device Directive the ‘Competent Authority’ of an EU member state is responsible for the legal status of products.

Recent jurisdiction confirms the fact that for the same product, a Competent Authority of one member state could classify a product as a medicine while another may consider the same product as a medical device.

For these kind of crossover discussions, also known as borderline discussions, Competent Authorities of Member States can follow the so-called Helsinki procedure where all opinions of different member states about legal product status are discussed.

At the moment, legal manufacturers of products under discussion, don’t have the possibility to interfere and there have been no official hearings. Although outcomes of the Helsinki procedure are not legally binding, most Competent Authorities follow up these opinions.

This means that products in self-care can have a different legal status in different European countries. The Helsinki procedure is currently being evaluated by member states.

The case of cranberry

An interesting discussion to follow within the borderline committee is concerning the mode of action of cranberries, and yes, we make cranberry-based medical devices. This shows the limited know-how of some manufacturers that provided insufficient data, conclusions made by member states without validation within the industry and interaction with industry representatives.

The discussion is not specifically limited to cranberry by itself. The outcome will have major impact on already long term available products such as nasal sprayers and vaginal lubricants. We believe that the discussion is part of the establishment process of the self-care medical device category. In our opinion the bandwidth of medical devices ends where physical mode of action is not part of the treatment process.



Since 2013, the self-care medical device category (more than 2000 firms) is represented by a designated committee within the AESGP (Association of the European Self-Medication Industry).

It is composed of national associations and the main multinational companies and SMEs manufacturing self-care products.

Knowledge - What do others and you know about self-care medical devices

The self-care industry has developed products with a specific primarily physical mode of action. Like every new innovation, regulations can take some to catch up

Medical Brands

and that may the case with medical devices. This doesn’t mean that the regulations are poor or a loophole. It means that authorities need to investigate and act on their responsibilities. It also requires that we all need to learn more about medical devices and their mechanism of action. But where can we study these?

It is definitely not part of any current pharmaceutical or medicinal study course by any university. But the same applies to other medical devices such as X-ray machines. There are no specific studies on self-care medical devices and so authorities and relevant associations and institutes have no full understanding (big picture) of these (self-care) medical devices.

This results in bizarre situations in which pharmaceutical experts (including authorities and policy makers) state that if you swallow a product with medical claims, it is a drug.

In short we have to conclude that the self-care market is changing; new regulations will have an impact; industry needs to provide substantial proof of evidence; authorities need to investigate and act as the category’s establishment continues.

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