The aim of this article is to give an in-depth explanation of how to perform EUDAMED login. You may want to know how to complete all the steps to register as an actor within the database, or simply to search for the information you need.
The video below is a part of our online course Introduction to the Medical Device Regulation (EU) 2017/745 and explains the topic of EUDAMED in greater detail.
To make a registration in this module or any other module, one needs to request a registration. After that, you will obtain an EU login to register information into EUDAMED. The European Commission has a guide on how to request registration to be able to log in and supply data into EUDAMED.
When requesting to register as an actor in EUDAMED, it is the competent authority in the country you operate that handles the application. It is up to each country to decide whether this shall be free of charge or come with an application fee. Luckily, this is only needed once for each economic operator. This is further specified in articles 28-33, 92 and in Annex VI.
If you just want to search for information in EUDAMED, you do not need a specific EUDAMED login. You can access the public parts of EUDAMED here.
There are also restricted parts of EUDAMED for registration as an economic operator and to register devices.
When you have been approved and registered as an economic operator (except distributors), you will receive your Single Registration Number (SRN). This will be your ID for all communication to EUDAMED and to identify you on certificates etc.
When you register as a legal manufacturer or an authorised representative, you also need to state the Person Responsible Regulatory Compliance (PRRC). This information will then be publicly available.
Bear in mind that this article covers only the information on EUDAMED login. If you want to learn more about the whole database, check out this article.
Would you like to know more about the Medical Device Regulation?
If you want to know more about understanding the European regulation for medical devices, take a look at our online Introduction to the Medical Device Regulation (EU) 2017/745 course. This online course is an in-depth overview of the Medical Device Regulation according to (EU) 2017/745 as well as related guidances, like MDCG, and how to apply to a notified body for conformity assessment.
It is suitable for anyone working with regulatory questions, such as RA and QA engineers, PRRC or management.
Pontus Gedda is a dedicated medical device specialist that has worked both in the industry, as a design engineer and project manager, and in the notified body world as a medical device lead auditor and manager.
He has vast experience in the MDR and its implementation thru hands-on experience from implementing the MDR at a notified body and leading that notified body through a joint assessment and getting designated as an MDR notified body.
He was a senior manager at a notified body during the transition from MDD to MDR and also a member of the NB-MED group.