Q&A with Mieke Roelants, Director Regulatory Affairs & Market Access, genae Belgium
Q: Which medical devices fall under the new EU MDR scope?
A: The MDR now combines Active Implantable Medical devices as well as the general medical devices. It’s really important for manufacturers to look at this new definition of a medical device, as well as looking at the classification rules. This because to check whether the device still falls under the MDR and also to see whether the updated rules have an impact on the classification of the device.
It’s also noteworthy to mention that medical devices that do not necessarily have a medical purpose such as colored contact lenses now also fall under the scope or the MDR.
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• 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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