The field of regulatory affairs "Regulatory Affairs" deals with everything concerning legal or normative requirements for placing medical devices on the market. From dealing with harmonized standards, to conformity assessment and post-market surveillance, RA experts are the point of contact for the requirements placed on these processes and activities by the relevant regulations for economic operators.
In Europe, these requirements are described in the MDR and IVDR, respectively.
The following pages describe how a device can be put on a wide variety of different markets worldwide. Often, a simple registration or confirmation of approval in the home market is sufficient. However, it can also be complicated; for example in China, the hurdles are particularly high. Additionally, in many African countries, a local contact is essential.
We will help you keep track of the different approval restrictions. Our experts know how to bring your product to market - whether in Europe, Asia or America.
Discover our "TrendReport" service
Full service for the reporting of trends in accordance with Art. 88 of the MDR. Learn more about TrendReport.
- Areas: Europe, Worldwide / Updates, New regulations and guidances 25/23
- Areas: Europe, Worldwide / Updates, New regulations and guidances 15/23
- In China, Post Market Surveillance (PMS) is an important component of the regulation for medical devices, ensuring the safety and effectiveness of these products.
- Areas: Europe, Worldwide / Updates, New regulations and guidances 05/23