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Regulation on Medical Devices 2017/745 (MDR): conformity assessment procedures

The new Regulation on medical devices 2017/745 (MDR), that will apply from May 2020, introduces a revision of risk classes to be attributed to medical devices and it also takes into account in a more direct and explicit way some types of devices that were previously not fully addressed (software, integrated systems, nanomaterials, etc.) In addition, it was made the choice to modify the conformity assessment procedures on medical devices, both in case a CE certificate by a Notified Body must be obtained and in case no third party evaluation is needed in order to put the device on the market.

It is out of scope of the present article to discuss all changes introduced by MDR and differences between the old Directive 93/42/EEC (MDD) and the prescriptions of the new MDR. Instead, it is interesting to address some general aspects that could highlight those differences potentially (or predictably) critical or even just burdensome in terms of further costs, times, and professional resources.

The MDR introduces the separation between the technical documentation and the conformity assessment procedures. Thus, it is established that the technical documentation needs to be considered as a set of documents that store some given information (e.g. design and specification details), sum up some given results (e.g. risk management, validations and verifications), plan and gather some given processes (e.g. clinical evaluations and post-market surveillance). This way, the legislator purpose comes out clearly to consider the technical documentation as a summary of activities not crystallised in time but continuous and progressive. At the same time, conformity assessment procedures are identified and defined exactly for the same purpose they had in the old directive and that is operations intended to determine the medical device conformity and its corresponding and consequent maintenance. In such view, the technical documentation defined in Annexes II and III of MDR represents the fundamental information within the conformity assessment process.

Thus, it is possible to draw associations between annexes of the old directive and corresponding ones in the new regulation (fig.1). The six annexes pertaining to the conformity assessment procedures of the old MDD (Annexes II to VII) are shrunk to three (Annexes IX to XI). This is due essentially to the merge into the new Annex XI of the old Annexes IV to VI. At the same time, Annex VII of the old MDD (for class I medical devices) disappears for two reasons: the technical documentation recalled into it is now included in the new Annexes II and III and second, the new MDR establishes from default to institute a quality management system as general obligation of manufacturers, that is not connected to the risk class of the medical device.

Fig. 1

Two changes are going to surface in the ordinary conformity assessment procedures: the need of a Notified Body for the assessment of custom-made medical devices that are also implantable class III and of reusable surgical instruments (fig.2).

Another change, of remarkable impact, is the introduction of specific additional procedures that will add to the ordinary ones. Said procedures are horizontal in the sense that they do relate to types of medical devices independently from their risk class (although the latter are anyway already fixed in most of the cases). These procedures have in common to require the recourse to a third body with respect to the Notified Body, such as the Competent Authority designated by a Member State in accordance with Directive 2001/83/EC on medicinal substances or EMA, which will have to provide a scientific opinion in cases of medical devices containing an ancillary medicinal products (opinion within 210 days), of medical devices based on substances that are absorbed or locally dispersed in the human body (opinion within 150 days), and of medical devices manufactured using or containing as integral part tissues or cells of human origin or their derivatives (opinion within 120 days). Another case is that of class III implantable medical devices and class IIb active medical devices intended to administer/remove medicinal products from the human body, where an Expert Group established according to Art.106 will have to provide a scientific opinion within 60 days from the communication, through the Commission, of the documentation on the medical device and its assessment by the Notified Body. In this case the opinion is not binding and the Expert Group can even decide, within 21 days, not to provide a scientific opinion.