Regulation on medical devices 2017/745 (MDR): focus on class I medical devices affected by up-classification
There is a predictably puzzling issue related to class I medical devices according to the present and old Directive 93/42/EEC (MDD) that will be up-classified according to the new Regulation 2017/745 (MDR): there is no transitional period established, contrary to what happens for those medical devices that are already today in upper classes and thus come with a CE certificate released by a Notified Body (NB) according to the old DDM.
The transitional phase in MDR is addressed in the prescriptions of Art.120. Of the twelve paragraphs comprising it, only paragraph 4 is applicable to class I medical devices. It establishes that a class I medical device according to the current MDD, placed on the market prior to 26 May 2020, may continue to be made available on the market or put into service until 27 May 2025. The point is that the placing on the market after 26 May 2020 does qualify the medical device as directly falling into the applicability of the new MDR but not of the old MDD.
In fact, the “making available on the market” is an action following the “placing on the market” (v. Art.2, definitions 27 and 28). It means that the possibility to continue to make a device available on the market until 27 May 2025 remains anyway subordinate to the putting on the market prior to 26 May 2020 for each individual medical device (v. also questions 18 and 19 of the CAMD FAQ). The placing on the market does not deal with a group of medical devices but with each single product (v. interpretative document of the Commission, preamble 2). In simple terms, a registration in a National database done prior to 26 May 2020 is not a sufficient condition for class I medical devices according to the old MDD to continue to make them available on the market until 27 May 2025, because each single manufactured and dealt with medical device is placed on the market in order for it to be made available.
If a medical device is class I according to the present MDD and it will continue to be class I according to the new MDR too, there is no problem or better the problem is easier to solve, given that the manufacturer can keep handling the conformity of its medical device autonomously and without the need for a CE certification by an NB.
A very different story is for class I medical devices according to the present MDD that will be up-classified according to the new MDR (e.g. many substance based MDs, many software, the very same reusable surgical instruments). In this case, to place the medical device on the market starting from 26 May 2020, the CE certification issued by an NB according to the new MDR will be necessary.
What is the problem? Up to date (July 2018) there are no NBs designated for the new MDR, obviously there are no NBs designated for the medical device categories involved, obviously the expected timeframes for CE certifications are not known, obviously there are no procedural references to follow to optimize the CE certification process according to the new MDR, as regards manufacturers duties on the conformity assessment procedures. In practice: will it be really feasible for a manufacturer to certify its medical device according to the new MDR prior to 26 May 2020?
To have a clue on the size of the potential issue, we can address the following numbers: only in the Italian Ministry of Health database there are over 1 million medical devices registered today. Of which about 321 thousands are class I (30%). By assuming that the up-classification will only affect the 10% of class I medical devices, it follows that 32 thousands medical devices should be certified. In an optimistic guess, said devices will be certified prior to 26 May 2020 by all of the same NBs active today (59 from the NANDO list).
Even if we focus only on the simple case of reusable surgical instruments (undergoing the certification by NBs solely for the aspects related to reusability of the device), is it safe to assume that we are not moving toward a gap of availability on the real market? Would such a potential gap be sustainable? Do we all really need to have to rely on last minute overproduction?
It is predictable that if the organizational inertia toward the new MDR remained as it is today, the 26 May 2020 date would only be an unrealizable deadline, thus the introduction of new decisions at the community level is desirable as soon as possible and in any case, because it makes no sense to wait and see, both for manufacturers and for the entire community.
