Your Regulatory Affairs Service
If you have any questions, do not hesitate to contact us.
European Medical Devices Regulation
The text of (EU) 2017/745 can be found here:
We have created an index for the quick orientation in the medical product regulation:
An overview of the EU Medical Devices Regulation can be found here:
The Eu Commission just published the first (in a row of 44) implementing act concerning the competency of the notified bodies.
for further details please refer to the "News-Blog".
Benefit from our knowledge and experience, we help you save time and resources with our experience.
We are currently monitoring regulations for more than 35 countries specifically for medical devices. If you do not have any information about the admission procedure in one of your target markets, we are at your disposal.
If necessary, we also provide contact with local experts who are willing to deal with your problems.
You are looking for information concerning the regulatory requirements for medical devices in a specific country?
This may be your landing page:
We prepared some of the most important aspects for the registration of medical devices outside of Europe by regions:
Any news we consider to be notable for the global regulatory requirements of medical devices will be published under:
This will keep you always informed.
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