Your Regulatory Affairs Service

New regulations in Europe require changes.

  • Do you already know the "European Medical Devices Regulation" EU 2017/745 (MDR)?
  • Are you prepared for the changes?
  • Do you have any questions concerning the changeover to these amended requirements?


If you have any questions, do not hesitate to contact us.

European Medical Devices Regulation

For those who seek to help themselves:


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:

For all the others:

For all the others:


Feel so free to contact us

First implementing act published

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".

Global Requirements for medical devices

  • You want to sell your medical products for the first time outside Europe?
  • Are you going to take the step across the big pond to USA?
  • Is your new market in Asia or the Eurasian Union?

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.

For the quick overview

You are looking for information concerning the regulatory requirements for medical devices in a specific country?

This may be your landing page:

For all of the others

We prepared some of the most important aspects for the registration of medical devices outside of Europe by regions:

Regulatory affairs News

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.