Balancing protection of public health and safety with the free movement of goods in the EU medical device sector: The case of ‘borderline products’ classification

In 2013, the CJEU ruled on the ‘Lyocentre’ case touching upon an important and contemporary issue in the EU Medical Device regime – the classification issue between medical devices and medicinal products. This problem is connected with the internal market v. protection of health dilemma as well as the choice between minimum and maximum harmonization. The Commission aspires to solve the above dilemma by going towards maximum harmonization in this area in the form of a proposal for a new Regulation on medical devices. My hypothesis is that the new regulatory framework may be able to better balance these objectives and also deal with several problematic issues of the medical device regime. However, it is not likely to solve the problem of borderline products. In order to check that, I will explore harmonization and internal market law literature as well as the relevant case law. My argument is that because classification of borderline products is strongly related to technology and medical science, which are constantly changing, a strict and inflexible regulatory framework cannot abide by their fast pace. I conclude that this problem cannot be fully eliminated, but it can be improved through soft law instruments, as they can be easily adapted to change.