The New EU IVD Regulation – What Will It Mean for Your Lab?
Christina Lingham:
Hi everyone, I'm Christina Lingham from the Molecular Diagnostic Europe Summit. I'm really pleased to have the opportunity to speak with David Barton, who's Chief Molecular Geneticist in the Department of Medical Genetics at our Lady's Children's Hospital in Ireland. You'll be talking to us about what the new EUIVD regulation will mean for IVD labs. He'll be giving a talk on the plenary session this May 23rd in Lisbon, Portugal.
David, thank you for joining us.
David Barton:
Thank you.
Christina Lingham
Tell us about yourself.
David Barton:
My name is David Barton, I am director of the Molecular Genetics laboratory at the Department of Clinical Genetics in our Lady's Children's Hospital in Dublin. I've been in this post for 23 years, and for nearly as long, I've been involved in the European Molecular Genetics Quality Network. Also, I've been working on issues around the regulation of DNA testing, of genetic testing, and in vitro diagnostic devices, or IVDs.
Christina Lingham:
Can you summarize what the new regulations are, and why it is important?
David Barton:
Europe has completely rewritten its regulations on diagnostic devices, and medical devices in general. These new regulations bring in four different risk classes of diagnostic device, and a whole lot of new compliance regulations, so devices have to essentially do what they say on the label, and be manufactured in a safe manner, and used in a safe manner.
Christina Lingham:
That's important for IVD companies to learn about this. Can you describe some key features of the new oversight?
David Barton:
Key features would be the risk classification from class A, the lowest risk, the kinds of tests, to class D, the highest risk kind of test, like HIV testing and blood grouping, and prenatal testing, and so on. Most genetic testing is classed into class C, so this brings the proper proportion of regulation to the different kinds of device, depending on their use, and depending how serious it is. If the device works incorrectly, or gives an incorrect result. Up to now in Europe, there's been much more cumbersome classification procedure, and all new devices were classed at the lowest risk class. There was a clear risk to patients, makes it very easy for companies to get tests out on the market, but it didn't necessarily serve patients well.
These new regulations are very welcome, even though there is an increased burden on IVD manufacturers to comply with these new regulations.
Christina Lingham:
And would you outline what some of the ramifications of introducing these new regulations for labs will be?
David Barton:
For labs that are just buying in CE marked, that's European approved tests, there shouldn't be much affect at all, except because of an increased burden of regulation, which comes of course with increased cost. Some manufacturers may drop some of their devices, if their devices aren't making that much money, they'll think maybe this is not worthwhile, re-certifying these devices for the new regulations. They may drop them from the catalog, and then labs will have to look elsewhere for those tests, or develop them in house. There are new regulations for that, developing their own tests in house. Up till now, there were completely exempted if you made your own test in house, cell DP's, as they're known in the US. In the new European regulations, these sorts of devices are regulated, and labs have to comply with the regulations. Not the same extent as commercial manufacturers, but there still will be some burden for individual labs that make their own tests.
Christina Lingham:
And can you outline what the ramifications of introducing these new regulations for IVD manufacturers will be?
David Barton:
The implications for IVD manufacturers are much more extensive, because most of the regulations are directed at commercial producers of IVDs. There will be a lot of compliance requirements right from test design, to test manufacturer, through to monitoring of performance, post market. There will be a European database of all the approved IVDs, and reporting each year on the performance of the IVD, and much more involvement of professional assessment bodies, known as notified bodies in European system. They'll be in looking at the design portfolios, they'll be looking at the quality of the manufacturing facilities, and they'll be looking at the scientific data that proves that the devices are doing what they say on the manufacturer's label, on the package insert.
Quite extensive additional responsibilities for manufacturers, and I know this is quite lot of worry in the industry. The general welcome for the new regulations, because they're tidying things up a lot, and benefiting patients. There is a concern that the burden may be too high in some cases, and as I mentioned, manufacturers may decide to drop some tests, because they're just not commercially viable anymore. There's also a concern about the capacity of the regulators to re-certify all the existing IVDs in the five year derogation period, because these regulations will finally kick in, in 2022. Even though that sounds like quite a lot of time away, if you have to re-certify every single IVD that's already on the market, as well as all the new ones that come down the pipeline during that time, that could be problematic for the new levels of regulations that have to be put in place.
Christina Lingham:
What advice do you have for people to prepare for these changes?
David Barton:
I would say find yourself a regulatory expert. You will be obliged to employ a regulatory expert if you're manufacturing IVD devices, and there are standard set out for the qualifications, and experience that those people will have to have. Even though you don't have to do that for another four and a half years, it's important that you do that right away, and catch yourself up to speed with the regulations. Make a plan, and start to implement that plan right away, because it's going to take at least those four years to get your files and your portfolios in place, and to get them through the regulatory system. The regulatory system's going to be a real bottleneck.
Christina Lingham:
Well David, thank you for your time and insights today.
David Barton:
You're welcome, I look forward to joining you at the conference in Lisbon in May.
Christina Lingham:
That was David Barton of our Lady's Children's Hospital in Ireland. He'll be speaking in the plenary session of the Molecular Diagnostic Europe Summit. If you'd like to hear him in person, go to moleculardxeurope.com for registration information, and enter the key code podcast. I'm Christina Lingham, thank you for listening.