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.
Cybersecurity and the Radio Equipment Directive
The Delegated Act to the Radio Equipment Directive (RED) has laid down new legal requirements for cybersecurity of wireless devices.
Export to Russia and the EAC marking
All information about product certification for export to Russia & EAEU member states. Certification Company assists you from A to Z.
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).