By Magali Wolff
You could say that the road to in vitro diagnostic medical devices regulation (IVDR) implementation has been rocky. We have read all of the documents, spent hours in meetings and felt our heart stop with every new announcement about the new regulations.
But the uncertainty has passed, IVDR is here and it is time to look at what the regulations really mean and how we can use them to our advantage.
Change is disruptive of course, but the truth is, IVDR will change the way we work for the better.
The future for LC-MS is bright and the road is clear
Time to look forward
Imagine taking that 10-page menu of laboratory developed tests (LDTs) in your lab and condensing it down into a handful that you can do really well. The rest are replaced by commercial tests that are highly reproducible and the regulatory burden to comply with IVDR falls squarely on the supplier. There are likely also cost savings here as the labor cost required to comply with IVDR will significantly increase the cost of LDTs.
The fact is that commercial suppliers of in vitro diagnostics like Tecan have been taking this seriously for a long time. Frankly speaking, there is an arms race going on to develop the best diagnostic tests and get them certified and, on the market, as soon as possible. Guess who benefits from that. You do. There will be more and more tests available and right now, you have a lot of influence over which commercial tests will be developed.
Make your voices heard – tell manufacturers what you need
You can talk to suppliers about IVDR and their intentions to release different products to know how to plan for the future. It’s entirely possible that even if a commercial device is not available yet, it is right around the corner so it really pays to have these conversations early. And guess what, even if every supplier says they are not planning to release a product that is applicable to your situation, with some justification you can continue to make your own.
IVDR ARTICLE 5(5) (d)
“The health institution justifies in its documentation that the target patient group’s specific needs cannot be met or cannot be met at the appropriate level of performance by an equivalent device available on the market.”
So, nothing really changes, right? Well, you do get suppliers battling it out to make new, standardized and convenient products that can reduce your workload. But your in-house LDTs will not be quite the same either, they will be better. The IVDR outlines a process for standardizing LDTs that will make them more reproducible and safer for patients. Yes, implementing these guidelines will take some work but this will only be done on essential LDTs that cannot be sourced commercially. The groundwork for establishing compliant LDTs will mean that you have a high quality and reproducible test for years and years to come.
You have come all this way through the IVDR journey, it is time to claim your reward.
Exactly how the new IVDR will be implemented and how testing will proceed has not always been 100% clear in the past. It has arguably been even more difficult to interpret how LDTs will fit in under IVDR and if they would be permitted at all. However, the uncertainty has gone, and the path forward is clear. IVDR simply puts the patient’s needs at the heart of everything we do. The best option for the patient is that we can go out and find a high-quality commercial test. However as quoted in the IVDR “if the target patient group’s specific needs cannot be met” then LDTs are the way forward. What is good for the patient is good for us all.
The future is looking bright. Yes there is work to be done but the path to completing it has never been so clear. If you are feeling overwhelmed or behind when it comes to the regulations then that is ok now, too. Manufacturers have a very good handle on IVDR and are happy to discuss your particular situation and help make things clearer.
If you would like to learn more about IVDR for mass spectrometry LTDs then download our whitepaper ‘Making sense of IVDR for LC-MS’. We have outlined all the deadlines and highlighted all the relevant parts of IVDR into one digestible document.
About the author
Magali Wolff is the Head of Global Reagent Marketing and Support at Tecan. She has been with the company since 2001. Magali and her team of product managers are dedicated to providing Tecan’s customers with the best service and quality products for their daily workflows.