Q&A with Sarah Andries, Regulatory Affairs Manager, genae Belgium
Q: Which medical devices fall under the EU MDR scope?
A: The MDR now combines Active Implantable medical devices as well as general medical devices under one regulation and covers all risk classes. It’s really important for manufacturers to look at the new definition of a medical device and to verify the updated classification rules. Manufacturers have to verify whether the device still falls under the MDR and if the updated rules have an impact on the classification of their device.
It’s also worth mentioning that medical devices that do not necessarily have a medical purpose such as colored contact lenses now also fall under the scope of the MDR.
Discover our other Q&A videos:
• Which country should I go to for my clinical trial?
• By when do I need to update the Clinical Evaluation Report (CER)?
• How will the new EU General Data Protection Regulation (GDPR) affect my clinical trial?
• Why is it important for manufacturers to focus on the health economics of their device?
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