Gain insight into EUDAMED today

The European database on medical devices (EUDAMED) is an Information Technology system being built and implemented by the European Commission (EC) to fulfill many of the obligations of the Medical Device Regulation (MDR — EU 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (IVDR – EU 2017/746), referred to in this white paper as the “Regulations”. It is a cornerstone of both Regulations and is intended to provide a living picture of the lifecycle of medical devices and in vitro diagnostic medical devices (IVDs) on the Union market. It integrates six separate and distinct electronic systems (referred to in this white paper as “modules”) that collate and process information related to Actor Registration, UDI & Device Registration, Notified Bodies and Certificates, Clinical Investigation/Performance Studies, Vigilance/Post-market Surveillance and Market Surveillance. Certain information will be publicly accessible via the EUDAMED public site, which will enhance transparency of the regulatory system for the public and healthcare professionals

Take advantage of our free medical device whitepapers 

Our whitepapers will help you understand how to perform better, reduce risk and make excellence a habit in your organization. See below some examples of other available whitepapers.

Interpret and implement standards and regulation with ease

BSI Compliance Navigator is the only platform designed by regulatory experts to help manage your medical device compliance, all in one place. Access thousands of standards and regulations, from MDR and IVDR to MDSAP requirements, we have you covered. 

What's more, Compliance Navigator will alert you of any upcoming changes to relevant standards and regulations, meaning you can prepare, far in advance. Use our Tracked Changes to see what's changed quickly and efficiently, followed by our Expert Commentary to help interpret and implement with ease. Save time, reduce risk and unlock market access with Compliance Navigator.

Find out more

Enter your first name
Enter your last name
Enter your job title
Enter your company name
Select your country
Enter your postcode
Select your industry
Select your industry sub sector
Size of your company
Let us know if there any other products or services you are interested in, if you have any other questions, or if there’s any additional information you’d like us to know before we contact you.
Please read the BSI Privacy Notice for further information regarding your rights.