In Vitro Diagnostics (IVD): an update in view of Regulation 2017/746

At least until May 2022 we will remain in the era of Directive 98/79/EC, started 20 years ago. Many clients ask for information on the new Regulation (UE) 2017/746, even if it seems too early. Only to some extent, though, as dealing with this issue now, in spite of the time still available, is part of the business logics and vision.

Now, as plans must be made in time, and before they shall be mandatorily applied. Now, because strategies must include more options and allow to understand which one is more suitable for one’s own reality. Now, because in an age of quantitative easing, “haste makes waste” is a technical topic as much as a risk management plan.

Still, I ask myself how it is possible that so much interest and so many requests do not reflect or transpire from the philosophy and logics of the new Regulation on in vitro diagnostics. May be it is time to stop for a while to summarise some data, factual certainties that the people in charge should be aware of, analysing them and draw the due consequences.

As of today (April 2018), in Italy there are little more than one million medical devices registered in the database of the Ministry of Health.

Note: The Ministry is to be praised for having created and maintained an important database for public access to at least a set of minimum information to be expected from a competent and loyal State at the service of its citizens. Italy is one of the few countries to make public the list of medical devices and IVDs legally marketed, including the identity of the manufacturers and a qualification of the products. It should also be asked if the Ministry was perhaps hindered by the European laws in their will to do more. So much so that the new Regulations 2017/745 and 2017/746 provide for the introduction of a centralised register with public access to information for EU (and world) citizens. The Italian Ministry of Health has set the precedent for the rest of Europe.

Of this million, only little more than 40 thousand are IVDs, practically 4% of medical products.

Note: it is lower estimate, as manufacturers with a location other than the concerned country are not bound to register class I medical devices (the more copious, among other things, but let’s thank Art.14 of Directive 93/42/EC for such transparency). The number itself of registered IVDs is underestimated, as Art.10(2) of Directive 98/79/EC is just like its predecessor.

Was it worth to introduce a specific legislation for 4% of the market? If, along with the Directive, it was decided to approve a new Regulation, then the answer must be yes. Still, of the 113 articles of the new IVD regulation, 110 are perfectly equivalent and symmetrical to those of the new Regulation concerning medical devices (more than 97%, if we wish to consider that the 3 differing articles could not find room in one of the others or we wish not to discuss their technical nature. One can say that the nature of IVDs is rather different from that of a medical device.

Yes, roughly speaking, the main feature of an IVD is to provide information, while that of a medical device is a technological support to the positive action on the patient.

Let’s talk about information, then. Information is based on knowledge and knowledge is based on research. One cannot provide information without knowing on what, why and how. Doctors can make diagnoses because they know all useful information, where it comes from, what it means, how to get it, how much to trust it. But knowledge requires “work (investigation) and perspiration”, just to quote Edison who, along with genius, did not despise the practicality of the patent.

So what is the status of the match between research and enterprise in Italy in the sector of IVDs?

Of the one million registered medical devices, about 34% is manufactured by Italian companies, that are in fact 31% of the registered manufacturers. The estimate should be reviewed because of all class I medical devices that are not registered but marketed by non Italian manufacturers.

Is the effect of the underestimate significant for IVDs?

It should, considering that all Italian manufacturers are obliged to be registered, while not all the foreign manufacturers and their products are. Actually, the effect of this discrepancy can be minimized for the number of Italian IVD manufacturers compared to the total (32%), but the effects on the registered IVDs is significant (46% of IVDs come from Italian companies). The number of products that are made in Italy could lead to think that the Italian manufacturers’ system holds the impact of the market globalization.

I don’t believe it is so.

Data are inflated by the fact that the registration of all non self-diagnostic IVDs and not belonging to Annex II is not mandatory: that is “only” about 80%. I’ll leave out the details of this calculation that, as a physicist, I set with conditions and correlations, but I think that a more reliable estimate is about 15% of the IVDs on the Italian market (i.e. half of the medical devices).

But why are we saying all this?

Because, if we compare this 15% of the IVD market with the 30% of the medical devices, it is easier to imagine the effect of research at a trading level. For reasons we are well aware of, Italy is striving to keep pace with global competition when this is based on knowledge and research, and today the world of IVDs is already a proof of that.

And tomorrow?

Thanks to the new IVD Regulation 2017/746 it will be even worse. The regulating framework will bring more duties for the companies in terms of financial and professional resources, and long before the enterprise can regain the costs with the marketing profits. For a research-based enterprise, a start-up or a small entity born out of innovation in the academic world or other similar realities, this means more obstacles towards concrete chances. Similarly, how many Italian enterprises can afford to invest in research?! How many can move from words to deeds?! And how many products of that 15% are really the fruit of a work conceived in Italy (instead of the notorious OEM-OBL agreement)?!

In conclusion, are we able to diagnose our own issues? At European level, which interests does Italy take care of? Judging from the new IVD Regulation, it is very difficult for me to believe that these are our interests. In an age of flat tax, spread and edge, I would like to remind that everything has a price. And not because I am thinking that in Germany (a country taken at random) whoever wishes to declare a religious confession is then bound to support it with their own money, or may be I am.

Written by: Amilcare Iacomino