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Eight Things You Need to Know About the European Medical Device Regulation

Setting up for long-term success

Jon Speer
Tue, 06/04/2019 - 12:02
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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

Submitted by Anonymous (not verified) on Wed, 06/05/2019 - 23:39

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).

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Submitted by Quality Digest on Fri, 06/07/2019 - 08:41

In reply to Botox is a drug not a medical device by Anonymous (not verified)

Thanks for heads-up

You are correct. Thanks for bringing that to our attention. We have removed that reference.
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