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January 26, 2017updated 18 Jul 2018 2:04pm

Companies must make necessary preparations ahead of new EU Regulation, says Medical Device expert

Clinical Trials Arena sits down with an industry expert to discuss the new EU Regulation due to come in effect in 2018

By Staff Writer

Clinical Trials Arena: What are the challenges you face from a regulatory perspective?

Industry Expert: In light of the fact that everything is changing due to the new EU Regulation, what is likely to remain an issue is that you still have to navigate the rules and regulations of different countries. In addition to that, there is of course no central authority where you can submit your documentation, which would then be divided into different countries. If such a body existed that would make processes even easier. At present, you have different regulatory guidelines in different countries meaning you need to be aware and knowledgeable of the all the rules and regulations.

CTA: How do you deal with those barriers? And what’s more, with the new EU Regulation coming into effect, how are you preparing yourself for the changes that will be implemented?

IE: Having worked in small companies, one way is to bring on board a vendor with localized knowledge of the country in which you’re running a trial. For me, it’s just not possible to be up to date with everything, especially when you don’t know all the languages. But, in regards to your second point, what you can do is follow what they’re doing and to read the documents that do come out. But as it’s not yet ready, it’s difficult to put things in place so it’s important to be aware of what discussions are taking place.

CTA: Do you feel as though these new changes will improve processes as they are now?

IE: It’s difficult to say – it’s definitely case of only time will tell. As I mentioned previously, if it is possible to have one body that receives submission documents where you can identify all the countries in which you want to conduct your trials that would be a significant help. Likewise, when it comes to safety and reporting during your trial, having one place where you enter your listings could save a lot of time in the long run. Furthermore, when you conduct trials, both pre and post CE marking, depending on your product, there are different guidelines on how you run the timelines. So if that aspect can be streamlined that would definitely help immeasurably.

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Additionally, a lot has been said about data protection and changes to data protection laws, which could have a huge influence on clinical trials. While I'm unsure how it will all play out, going forward this could present a huge challenge for the industry.

CTA: In what way exactly?

IE: In terms of how the industry handles those changes. The impact the new amendments could have on data protection laws could be far-reaching. How will it affect the way in which we gather patient data, or the way we get approval for from the patient and what they consent to, and further analysis, etc. These are questions no one really knows the answers to.

CTA: That’s interesting because with the advent of mHealth and new technologies, ways to accumulate and manage data are of course changing, and that brings about its own ethical questions.

IE: Absolutely. What sort of impact these changes could have will be interesting to see. There is a sense that we might be walking into the unknown, but we have to wait to find out how things will unfold.

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