The European Medical Device Regulation (MDR) is a new set of regulations that governs the production and distribution of medical devices in Europe, and compliance with the regulation is mandatory for medical device companies that want to sell their products in the European marketplace.
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If your company was already compliant with the Medical Devices Directive (MDD), don't be fooled into complacency: The MDR represents brand-new regulations with significant changes.
For those seeking to better understand why the regulations have changed, and what some of the major changes are, let’s take a look at some of the most common questions we hear from our users.
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Comments
Botox is a drug not a medical device
You state Botox as an example of a medical device, Botox is a drug and is not a dermal filler. It has a pharmacological effect of muscle, not filling facial wrinkles. An example of facial fillers would be Radiesse (brand name).
Thanks for heads-up
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