The European Commission has issued a revised version of the Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices (Borderline Manual). The eighteenth version (1.18) of the Borderline Manual includes guidance on the classification of twelve additional types of products – 94 in total – including two new mobile applications. However, despite the revision of the Borderline Manual, some classifications could potentially change under the new Medical Devices Regulation and In Vitro Diagnostic Regulation, which come into effect in 2020 and 2022 respectively.
The Borderline Manual provides guidance on the classification of several categories of products that might fall into the definition of a medical device. The regulatory classification of a product – generally determined on the basis of its primary mode of action, intended use, and product claims – is important as it determines, for example, the authorisation process (e.g. CE marking for medical devices) and marketing strategy of a product (e.g. medical claims are permitted for medical devices and medicinal products).
As decisions on the classification of a product remain a competence of the Member States, they may lead to different interpretations within the EU (as confirmed by the CJEU in case C-109/12). To ensure a uniform approach, difficult cases can be discussed in the informal Medical Devices Expert Group on Borderline and Classification (MDEG), the consensus statements of which are published in the Borderline Manual.
The revised Borderline Manual indicates that the following products should generally be classified as medical devices:
- Alum styptic pencils (Class IIa)
- Tissue expanders used in the breast (Class III)
- Dura guard for use with a craniotome (Class III)
- Heart bypass cannulae (Class III)
- Liquid nitrogen for cryopreservation of cells and tissues of human origin for medical purpose (Class IIa)
- Mobile application for the assessment of moles (Class I)
To the contrary, the following products should in principle not be considered as medical devices:
- Products intended to reduce the effect of alcohol
- Radiation shields
- D-mannose for the prevention of urinary tract infections
- 8-MOP solution in extracorporeal photochemotherapy
- Microplate washers
- Mobile application for managing pictures of moles
While it is recommended for manufacturers to take into account the consensus statements the Borderline Manual, the views expressed in the Borderline Manual are not legally binding. Based on the various criteria proposed by the CJEU for borderline determinations, each assessment must be very fact-specific and needs to take into account many concrete elements, and the guidance provided in the Borderline Manual often lacks such detailed and balanced review.
It should be noted that Article 13(1)(d) of the Medical Devices Directive contains a mechanism to – partly – solve borderline questions at the EU level as it allows Member States to request that the European Commission decide whether a specific product falls within the definition of a medical device. The first Commission implementing decision on this basis was taken on 8 August 2017 with respect to cranberry products, which were not considered to fall within the definition of a medical device.
Article 4 of the new Medical Devices Regulation strengthens the powers of the Commission, also allowing it to decide on these issues at its own initiative (after consultation of the relevant agencies), to ensure a more consistent classification of borderline products in the EU. Importantly, some of the positions taken in the Borderline Manual may have to be reconsidered due to potential reclassifications brought by the new Regulation(s), which not only broadens the definition of a medical device (e.g. by considering the prognosis of a disease as a medical purpose) but also subjects some products without medical purpose to the new rules (especially products for aesthetic purposes). While the changes introduced by the new Regulation(s) are expected to resolve some of the borderline questions that exist today, diverging views on the classification of complex products are likely to persist.
This post was co-authored by Eftychia Sideri.