Welcome to the Hoodin RAQA Deep Dive Sessions blog post! In this edition, we'll explore insights from our recent session with Veronika Valdova, an expert in Global Regulatory Affairs.
This post serves as a valuable resource for navigating regulatory challenges focused on situations where a product straddles the drug-device line in different regions.
Theme: Drug in the US, Device in the EU: Navigating the Treacherous Waters of combined registrations
Guest speaker: Veronika Valdova
Some of the questions discussed were:
Share a specific example you've encountered where a seemingly straightforward medical device ended up blurring the lines and caused classification challenges across different countries?
What are some of the biggest hurdles they might encounter when a product straddles the drug-device line in different regions?
What key considerations should they prioritize when working with products that might have dual classifications?
Walk us through a specific case study where you successfully helped a company overcome a drug-device classification hurdle?
Share some top 3 actionable tips – things our RAQA audience can actually do today – to better navigate the complexities of drug-device classifications, especially for products with potential variations across regions?
Further down in this blog post, you will find the questions that came from viewers and that Veronika answered during the session.
Watch the recorded version of the session
🎙️ Speaker: Veronika Valdova
📚 Theme: Drug in the US, Device in the EU: Navigating the Treacherous Waters of combined registrations
🗓️ When: May 2, 4pm CET / 11am EST
⏱️ Duration: 35 minutes
Q&A and Resources:
Questions from the viewers addressed during the session:
For the US, can we compare a device part from a combination product? I mean, using a combination product, only submit a 510k for the "device part" (when the drug is a well known drug)?
In your expert opinion, how do you see these classification guidelines adapting to keep pace with these advancements, particularly in areas like combination products?
If you have a very noval product, where or how would you do your research in other potential similar products?
Assets from the session
Reach out to Veronika for any further questions on collaboration and communication tips, and other RAQA topics too of course!
Rule 21 guidance: https://health.ec.europa.eu/system/files/2021-10/mdcg_2021-24_en_0.pdf
MDCG - borderline products: mdcg_2022-5_en.pdf (europa.eu)
MDCG - classification: mdcg_2021-24_en_0.pdf (europa.eu)
Arete-Zoe, LLC assists manufacturers in preparing technical documentation for submission to EU notified bodies and national regulatory authorities to certify their medical devices in compliance with Medical Devices Regulation (EU) 2017/745. Our team has an excellent record in preparing documentation that successfully passes the certification process. Additional services include notification and follow-up with national competent authorities and notified bodies.
Contact Veronika Valdova for more info https://www.linkedin.com/in/veronikavaldova/
Arete-Zoe, LLC website: https://www.aretezoe.com/medical-devices
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