EUDAMED - European Database on Medical Devices
Are you a manufacturer, authorised representative or importer of a medical device? If so, you will soon (most likely in May 2022) need to register information about yourself, your company and the medical device in EUDAMED.
MDR & Implementing Regulation (EU) 2021/2226
Implementing Regulation (EU) 2021/2226 makes possible for manufacturers of medical devices to provide electronic instructions for use only. Read more about the conditions of EU 2021/2226.
Breaking news: European Commission published second batch of harmonised standards under MDR
On January 4, the European Commission recognised nine harmonised standards for medical devices that manufacturers can reference in order to satisfy conformity requirements under the Medical Devices Regulation (MDR 2017/745).
MDR 2017/745 Implementation: Are you prepared?
MDR 2017/745 is in force. Get all the updates and requirements introduced by the new Regulation.
CE marking for medical software & Apps
Software and apps that are essential to the proper functioning of a medical device must be CE marked.
Medical Devices Regulation 2017/745
Due to COVID-19 the implementation date of Medical Devices Regulation 2017/745 has been postponed until 26 May 2021.