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Medical devices made of substances and Regulation EU 2017/745

The date of application of Regulation EU 2017/745 as amended was officially postponed of one year (May 2021), also postponing the abrogation of Directive 93/42/EEC; however, many aspects linked to the applicability of the Regulation itself remain partially unclear. One of the problems, identified as early as its first drafts were published, concerns the so-called medical devices ‘made of substances’ (shortened as MDMSs).

First of all, the Regulation clearly explains that special specific procedures shall apply in the case of devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed in the human body. This definition opens, in theory, to the possibility that a MDMS does not fall within the applicability of special procedures; however, it should be specified that no guideline was published on this regard by the European Union and, without it, it is plausible that manufacturers should demonstrate through appropriate data that their MD is not absorbed by or locally dispersed in the human body (which thing involves a financial as well as time-consuming commitment, presuming that it is feasible).

Rule 21 for the classification, introduced by the Regulation, is specific for MDMSs, and based on it, MDMSs can be classified in class IIa, IIb or III depending on their intended use. This case also refers to MDs made of substances that are absorbed by or locally dispersed in the human body. No class I then, for the MDMSs regulated by the new Rule that, as such, shall follow a procedure for their conformity involving the intervention of a Notified Body (NB) before being marketed.

In addition, all MDMS manufacturers, as defined by the Regulation, shall produce data to ensure not only that the mechanism of the product falls within the scope of the Regulation (not involving pharmacological, immunological and metabolic media, called FIMs), but also that it complies with the directive on medicinal products as far as the kinetic profile of the substances inside the human body is concerned.

Such data can plausibly be obtained only through studies evaluating absorption, distribution, metabolism, excretion etc. The NB will also ask for an opinion from EMA or from a Competent Authority on the medicinal product directive of an EU Member State to verify the conformity of some categories of these MDMSs regarding the aspects just described.

The MDCG – a group of experts selected by the EU to clarify specific aspects of the application of the Regulation – has recently published some guidelines clarifying even more how stricter are the requirements for MDs made of substances that are absorbed by or locally dispersed in the human body than in the Directive. Just to give an example, it clarifies that the clinical assessment carried out based on data from literature shall consider all the substances composing the MDMS, so it is plausible that the clinical assessment documentation drafted according to the directive requirements will be no more sufficient for the certification of the products for the Regulation.

The picture described above points out that the compliance with the requirements imposed by the regulation will be much more burdensome for the manufacturers, in terms of resources, time consumption and skills.

It should be specified that according to the provisions of the second Corrigendum of the EU Regulation 2017/745, all class I MDs to be reclassified can be marketed until May 2024, in the case they have a Declaration of Conformity drafted in compliance with the directive before May 2021.