Who needs to register EUDAMED?
Every economic operator (EU and non-EU manufacturers, authorised representatives, system/procedure pack producers and importers) has to register as an actor in EUDAMED and provide the required information.
Can I register in EUDAMED?
You must register data on yourself, your company and your medical device in EUDAMED. Information in medical devices and manufacturers is included in EUDAMED. After registration you will get a Single Registration Number (SRN). You need to register before you market a new device.
How do I get access to EUDAMED?
Access to MDR EUDAMED is restricted to users identified by their EU Login account. For further information on EUDAMED, please visit the medical devices section of the European Commission website.
Is EUDAMED available?
The notice foresaw the launch of a fully functional Eudamed in May 2022. However, at its meeting of 12 March 2020, the MDCG agreed that the Commission will make the different modules of Eudamed available on a gradual basis as soon as they are functional.
What is Eudamed database?
Eudamed is a database that will be used to monitor the safety and performance of devices under the Medical Devices Regulation (MDR 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (IVDR 2017/746).
What is Eudamed actor?
EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in-vitro diagnostics medical devices including the actor roles.
What is an actor in Eudamed?
The actor module, which is key to accessing and using Eudamed, allows economic operators to obtain a single registration number (SRN) which provides an EU-wide unique identification.
What is Eudamed full form?
The European Database for Medical Devices, or Eudamed, is a major part of Europe’s new medical device and IVD regulations.
How do I register my medical device in Europe?
How to achieve Europe Medical Device Registration and apply CE mark?
- Establish and maintain a Medical Quality Management System (QMS)
- Test your product in order to demonstrate compliance with applicable standards.
- Prepare a Technical File / Design Dossier for each family of products that you wish to obtain CE mark for.
What is the status of EUDAMED?
The EUDAMED launch has been postponed with a two-year delay compared to initial expectation, until May 2022. However, the European Commission has announced that some modules of EUDAMED will be made available to users before the official EUDAMED date of application in May 2022.
What is EUDAMED database?
What is the status of Eudamed?
Do I need to register as an actor with Eudamed?
The Commission is not in a position to require the use of the Actor registration module until EUDAMED is fully functional according to the Medical Device Regulation and additional national requirements on registrations can therefore not be excluded.
How to register in Eudamed as a non-EU manufacturer?
To register in EUDAMED, the non-EU manufacturers must have an active authorised representative and submit with the registration a mandate summary document EUDAMED registered users For an actor already registered in EUDAMED, all persons who intend to act on behalf of this actor need to enter an access request.
When do you have to register a vehicle in Eudamed?
In addition, their registration in Eudamed will be mandatory earlier if there is a serious incident that occurs or a field safety corrective action to apply on them. That requires their registration as soon as possible and at least before a follow up or final vigilance report is submitted, Crowder noted.
What is Eudamed and how does it work?
It will function as a registration system, a collaborative system, a notification system and a dissemination system (open to the public) and will be interoperable. EUDAMED is structured around 6 interconnected modules and a public website: What is the state of play of the implementation of EUDAMED?