More interesting things from the RAPS Convergence conference.
If you do anything in the IVD sector in Europe and did not attend that conference, that’s a pity. The program on EU IVD regulation was truly outstanding. I do not often see such a good program on EU IVD regulation in one place – if you weren’t there you really missed out on an excellent program. I really hope they repeat it again next year. Overall the EU medical devices regulation program was very very good, with a very high quality of extremely relevant speakers.
So let me summarise some things for you that the IVDR brings, taken from this program.
Regulatory quantum leap even more quantum than originally expected for IVDs
I have discussed the quantum leap in regulation for IVDs before on this blog and described it in the White Paper on the IVDR that Gert Bos and I wrote for BSI. As you can see the current estimation of IVD manufacturers needing a notified body in the EU have gone up from the conservative 80% to now 90-95% as it becomes more transparent what legacy products manufacturers have in their portfolios. Will all these products make the cut of the IVDR? The expectation of the notified bodies and industry going on the record is that this will not be the case.
This is a good start to bridge the gap created by the leap:
Are all the IVD companies working on gap assessments already like the sensible medical devices companies are? Nope. Some are, but most are not because they think that five years transition period is plenty long to get things in order and 2022 is not even on the horizon. Read on, and you will see that five years is very short for what you need to do, especially if you are a company with limited experience with notified body review of technical documentation for your products. Lucky you: we have developed gap assessment tools for IVDR as well in the mean time and will be happy to help you or leverage our network of technical experts to help you.
“Anybody that is not seriously thinking about getting rid of products is overlooking things”, was one of the industry statements in the IVDR session by one of the companies that is well on its way with its IVDR work.
Portfolio rationalisation is the thing because you will quickly find that not every little self certified IVD with almost no data and half a technical file (if you’re lucky) is worth the investment of remediation to IVDR standards. You will need to set up end of life programs for the IVDs you retire.
People and notified bodies
More even than for general medical devices expertise of regulatory staff and retaining them is crucial because there are relatively few IVD professionals in the market.
The current expectation is that there will be five (5) notified bodies that will be accredited for the IVDR. That is not a lot for the tidal wave of applications that will come their way. Also with regard to the IVDR there is no grandfathering (see below for more in this regard). This means that a constant dialogue with your notified body will be crucial to make sure that you keep your place in the queue and have the best chance of understanding what is required.
If you have never dealt with a notified body before, start doing that immediately to make sure you’re in the priority line for boarding. You may well miss your flight if you start talking to them only when all the seats are sold, which they will be towards the end of the transition period. Notified bodies will focus on helping existing loyal customers and will be less focused on companies that say they might cost them some time. So you might already have your ISO audits done by the notified body of choice to make sure you have a foot in the door. Sounds logical right? Maybe it sounds even so logical that even your management can understand it.
Invest in structures now – PMS and clinical data
The IVDR will require much more in terms of structures than the IVD Directive, mostly in the field of post market follow up but also in the way the data is presented in your technical documentation.
The IVDR requires more in terms of keeping the technical documentation consistent with any other statement that you make about the product.
Your 510 (k) for an IVD will not be sufficient. It will contain some data but not enough and not in the right structure. The IVDR requires a lot of new things in terms of performance evaluation and how to structure that data. So better start collecting data now using you PMS procedures. The better they are the better this works.
The technical file also needs to be up to date as per the current date, and that date changes every day. When did you last look at the data for your product?
Your current technical file structure will not be compliant under the IVDR, so there’s significant work to be done there. Organising all your current probably not super high quality self certification technical files in an IVDR compliant set of technical documentation takes more work than you think. Probably you do not have many people in your regulatory department for this because you never needed them before.
Timeline management and transition
In the MDR universe a minority of self declared products cannot benefit from the so-called ‘soft transition’ that allows MDD/AIMDD or IVDD certificates to overrun the date of 25 May 2022. In MDR land this typically affects software (often class I) and low risk devices. But in the IVD universe most IVDs are currently self certified so do not have a certificate, which means no soft transition for currently self-declared IVDs. That is the vast majority. This a a potentially enormous bottleneck. If you are not on the bus of one of the five notified bodies for IVDR timely you will not have an IVDR certificate for your product before the end of the transitional period. This means no more placing of product on the market. You will be like While E Coyote going off the cliff, with your more survival oriented competitors picking up your market share quickly. That is not a nice place to bounce back from.
The new Class D IVDs are even more affected because the reference laboratories that need to look at those applications will not be designated until right at the end of the transition period.
The link with data protection legislation and the magic freezer
The IVDR has a link with EU legislation in the field of personal data, the General Data Protection Regulation (GDPR), which is applicable as of 25 May 2018. As was explained in the RAPS Convergence program, many companies have all kinds of samples lying around in their magic freezer because they never throw away good samples, which comes in handy when you need to de performance evaluation for the purposes of certifying your existing IVDs under the IVDR. But wait what – is that even allowed? See my presentation in the IVD program for answers:
It follows that implementation of the IVDR must go hand in hand with a serious implementation of the GDPR as well. The GDPR is just as relevant for samples that are not left over. Every time you use an IVDR regulated sample this raises a question of GDPR as well. As we saw in the session that I presented in there are big differences in this between the US and the EU.
I bet you thought the title for this blog was kind of hyperbolic when you started reading. I hope you have a more nuanced perspective because there may very well be mass extinction. There are so many possible critical missteps. When missteps exist, missteps will happen – pardon the cynicism. Many companies will suffer because they will not make the cut. It is inevitable. So, as I told the audience during my presentations at the conference: choose whether the chaos that will inevitably happen is your chaos or someone else’s chaos. Because chaos will happen, whether you like it or not.
Transitioning to the IVDR is rocket science, there are not many IVD rocket scientists around (so hold on to the ones you have), the rocket certification bodies are few and will be very very busy. Get your application wrong and you’re back at the end of the launch queue. And if you’re not ready in time you miss your launch window, meaning that you lose market share that may be very difficult to recoup.
So, if you’re an IVD company with IVDs on the market in the EU: don’t be a dinosaur. We all know what happened to them.