Early problems caused by Regulation 2017/745 on medical devices: MedTech Europe raises the alarm level
The title is not wrong, the new European Regulation on medical devices 2017/745 (MDR) is already causing problems to manufacturers, or better said up to now to manufacturers only, tomorrow who knows, even before coming into application.
A first easy question: you are a manufacturer whose medical device CE certificate against the old Directive 93/42/EEC (MDD) has been issued by a Notified Body (NB) designated by United Kingdom, who are you going to apply to for the CE certificate against MDR? Say you choose to change NB, which place do you think you will have, as new customer, in the priority list of your new NB? Say you stay with your British NB, will your current CE certificate be valid after March the 30th 2019? Then, does it really worth the while wondering whether you will get in time your CE certificate against MDR?
Multiply only this first real problem by the 30% of all CE certificates issued up to date (estimate of certificates released by British NBs on the total) and, as if by magic, even without having touched slightly in the matter the requirements of MDR, you can figure out already that the situation is not good.
Even less good if you consider that there are current class I medical devices that will be up-classified by MDR and thus will need a CE certificate issued by NB contrary to now, consequently going to increase the total amount of certificates to be released and the NBs workload.
Even less good if you consider that the total number of NBs has been steadily diminishing from 2012 (87) up to now (59). That the 5 Turkish NBs will not even start the designation process against MDR until the same Turkey will approve its national transposition of MDR. That, in the meanwhile, 3 NBs entered into a single consolidated group and it cannot be given for granted that the sum check will make the total, given that the merge caused 2 less NBs applications against the MDR and it remains to be proved that the overall efficiency of the group will be the sum of the single efficiencies of the previous three members.
Even less good if you think about the operative capabilities of NBs already today against the MDD (less complex than MDR), by taking into account that the number of CE certificates for new medical devices has been steadily diminishing from 2013 to 2017 (-24% estimated on a sample of 24 NBs).
Have we even started to talk about the new requirements falling on NBs in the certification process against MDR?
Even less good if you consider the needed time to update and introduce the new harmonized standards (about 230 for medical devices and 50 for IVD) to take into account the new requirements of MDR, that manufacturers usually follow to satisfy the essential requirements and thus presume conformity to them. Overall, documents that manufacturers should theoretically know and apply before starting a certification procedure, that is in the design phase already.
Even less good if you consider the established deadlines valid at the moment:
- May 26th 2020 for class I (including class I medical devices up-classified by MDR and thus in need of a CE certificate from day 1),
- May 27th 2022 for medical devices currently certified according to Annex IV of MDD,
- May 27th 2024 for all other CE certificates according to MDD.
Take into account that said deadlines are optimistic because they do occur if the CE certificates have been issued close to 2019, given the threshold of their natural 5-years (at maximum) validity that determines the obliged shifting to the new certification, all of it even subordinate to the absence of significant changes to device design and intended uses. It goes without saying that, in the best scenario, only 1 upon 5 CE certificates will reach the 2024 deadline, given that a NB will not issue all the new CE certificates of all its customers in the solar year 2019 against MDD (and simultaneously work on the new ones against MDR).
Even less good if you think that, in the best scenario, the early active NBs against MDR will start their activity in Q2 of 2019, that is only exactly 1 year before the first deadline. Are you wondering how long it will take to get a CE certificate from the submission date? Do not do it, know instead that:
- The current capability (to 2017) of yearly CE certificate issues, averaged on 24 NBs (sample of 40% of the total population of NBs), is 824.
- Multiply by 59 NBs that unrealistically will be operative in 2019: 48.616.
- Multiply by 5 (likely time rated deadlines of all certificates in a 5 year timeframe): 243.080.
- Now know that, according to MedTech, the total amount of medical devices in need of CE certificates is about 314.000.
Have we even mentioned that the new Regulation on IVD 2017/746 will shift from 10% to 85% the percentage of IVD in need of CE certificate?
I would like to add that the situation is even less good if you consider that the process that starts with the NB application submission and ends with its authorization, can last about 18 months and the first starting date available to all NBs was set at the end of November 2017. In the best scenario, those NBs active at Q2 2019 will find themselves anyway in position to have to make choices, willy-nilly.
Have we already entered into the merit of discussing the changes introduced by MDR in terms of requirements, duties, and obligations that will lead to an increased complexity of the certification process both for manufacturers and NBs?
At this point: is it inevitably necessary to get to the point to witness the grim show of invoking the phantom of the threat to the safety of patients of the whole universe, if the toy breaks down?
That the situation is not good is crystal clear, yet the remedies are at hand, not costly (better said for free), not compromising the safety of anybody (except for intentional criminal acts), not requiring additional duties or resources:
- Rethink the dates of current deadlines, maybe by making them depend on the verification of the effective functioning of a minimum (to be established) number of NBs.
- Maybe introduce a (temporary) distinction between really new devices and devices that are already on the market against MDD (legacy products), in order to create parallel paths with appropriate operating modes.
- By considering that the current prescriptions of MDR already establish, in the transitional phase, the extension of applicability to medical devices conform to the old MDD of some new MDR requirements of relevance (vigilance, post-market surveillance, registrations), the premises for an agreement on delays already exists, it is enough to spread them out in a way sustainable by the system.
After all, the main problem is the CE certificate cutoff for placing on the market, thus it is a technical problem that needs a practical management. The points of principle and of substantial agreement on the content aspects of MDR have not even been addressed, nor would be minimally changed.
Even easier to agree on and objective in the matter these proposals become if compared with the current available amount of NBs in other legislative frameworks where CE certification is mandatory, obviously to weigh with respect to the size of the reference markets, but also (and mostly) with respect to the very same complexity of the certification process:
- Personal protective equipment: 97
- Noise emission in the environment by equipment for use outdoors: 59
- Electromagnetic compatibility: 111
- Simple pressure vessels: 78
- Non-automatic weighing instruments: 101
- Measuring instruments: 100
- Equipment and protective systems intended for use in potentially explosive atmospheres: 73
- Pressure equipment: 292
- Marine equipment: 47.
Scritto da: Amilcare Iacomino
