Implementing Regulation (EU) 2021/2078
Read complete text of the Implementing Regulation EU 2021/2078 related to EUDAMED - European Database on Medical Devices.
Implementing Regulation (EU) 2021/2226
Are you a manufacturer of a medical device? In that case, since January 2022 it has been possible under certain conditions to provide instructions for use exclusively in electronic form. The conditions under which this is possible can be found in Implementing Regulation (EU) 2021/2226. In our knowledge base you will find more information about...Read More →
Medical Device Regulation 2017/745
Medical devices, accessories of medical devices and medical software must comply with all the relevant design, safety and performance requirements, in accordance with the Medical Device Regulation 2017/745. In order to define a product as a medical device, it must first be classified based on a risk classification. Depending on the main purpose and the...Read More →