Substance-based medical devices - Regulatory implications enforced by the EU Medical Device Regulation

Many over-the-counter medical devices are substances or combinations of substances. Examples are, nasal sprays primarily used for common cold symptoms, lozenges or sprays to relieve sore throat, cough syrups, wart removal gels, anti-obesity capsules, vaginal gels and dermal creams for eczema or psoriasis. 

The consequences of the Medical Device Regulation EU 2017/745 (MDR) becoming applicable in May 2020 are significant and burdensome for manufacturers of these substance-based devices. As a start, a new classification rule (rule 21) is introduced for medical devices, that are composed of substances, with Class IIb as a default risk class. As a consequence, most of these devices will be classified in higher risk classes. 

Rule 21 implies that as of May 26 2020 substance-based medical devices no longer can be classified as Class I. Lozenges, nasal - and throat sprays or ear drops currently on the market as Class I medical devices, will now face a conformity assessment procedure and notified body involvement. Also, invasive devices currently often classified as Class IIa, will be up classified to Class IIb (e.g. vaginal gels) or even Class III (e.g. anti-bloating or anti-obesity capsules). 

A challenging requirement is the additional verification testing according to Annex I to Directive 2001/83/EC covering medicinal products for human use.  Pharmacokinetic studies, such as absorption, distribution, metabolism and excretion and additional toxicological testing, including local tolerance are now required. In addition, if these devices that are intended to be introduced into the human body and that are absorbed by or locally dispersed in the human body, the manufacturer will face a consultation process, in which the Notified Body will seek a scientific opinion from a competent authority on pharmaceuticals or from EMA in the certification process. This scientific opinion is not binding for the Notified Body, who is dealing with the certification of the device, but in practice this will not make much of a difference. Manufacturers will face more scrutiny during the conformity assessment process. 

Substance-based devices are often considered borderline and might as well be covered by other Union harmonized legislation, such as medicinal products, cosmetics or food. The MDR addresses this topic in recital (7), (8) and (9). The Commission can decide on a case-by-case basis whether a product falls within the scope of the EU MDR. In other words, is the product considered a medical device or not?

For manufacturers of substance-based devices, meeting these new requirements comes on top of the efforts needed to provide stronger clinical evidence to support the safety and performance of their devices. It might well lead to additional resources being required and significant investments in pre-clinical testing and clinical investigations, to keep these products on the market under the new legislation. A valid question is if all the efforts and investments are worthwhile. 

Considering that the clock is ticking and that the date of application of the EU MDR is approaching rapidly, in particular for manufacturers of Class I products that cannot be placed on the market after May 26, 2020, it is time to take decisions and act swiftly. What is your regulatory strategy? What does your future product portfolio look like, considering the efforts and expected return on investment? You might need to pick your battles. But pick them and start fighting!


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Inette Nieveen
Post date: February 22, 2019
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