EUDAMED – Medical devices is a sector that has experienced tremendous growth over the last decade. This category of pharmaceutical products is particularly diverse: it ranges from sterile gauze used to dress a wound to a computer application which counts your heartbeats or an ICU ventilator.
Since 2017, medical devices have been subject to their own regulation, which applies across the entire EU market. The Regulation 2017/745 approves, amongst many other matters, the creation of the Eudamed database, a tool developed by the European Commission to facilitate the exchange of information between European authorities. Once it is fully operational, it will enable users to find basic information on all medical devices marketed in the EU. Would you like to find out more about EUDAMED? Read on!
Eudamed: a database of medical devices in the EU
The publication of the Medical Devices Regulation 2017/745 has presented new challenges for all companies developing products in this sector. Furthermore, the changes do not only affect manufacturers; they also have an impact on many establishments such as laser hair removal salons, sports centres and a wide range of other businesses where medical equipment and products are used.
The publication of specific regulations for this category of articles has, of course, been accompanied by the the creation of a range of mechanisms, tools and resources that will enable the European Commission to monitor compliance with Regulation 2017/745 effectively y to regulate medical devices placed on the European market.
Let’s take a look at these 3 points of the Regulations:
- Articles 27 and 28: The creation of a database of Unique Product Identification System (UDI, (acronym)
- Article 29: A electronic registration system for medical devices
- Article 33: The creation of a European database on medical devices (EUDAMED), which includes products placed on the market.
With these three articles, the European Commission achieves:
- A new numbering system for medical devices, shared by all authorities in the eurozone.
- Create a portal for the electronic registration of medical devices which are launched on the market, and where information on those already in shops is regularly updated.
- Start the creation of a database managed by the European Commission, aimed at the authorities themselves, as well as the general public and professionals, and which is expected to draw on the data contained in the electronic register system.
In short, the main objective pursued by the European Commission through the creation of these digital tools for the monitoring and recording of medical devices is:
"To improve transparency, enabling the public and healthcare professionals to have better access to information, and to facilitate coordination between the Member States of the European Union".
Modular structure of the Eudamed database for medical devices
In order to implement the Regulations (EU) 2017/745 and 2017/746 on medical devices and in vitro diagnostic medical devices The Eudamed database must fulfil a dual role. On the one hand, it must be capable of storing reliable and up-to-date data on medical devices available on the single market. On the other hand, it must facilitate communication between the various parties involved in the registration of a medical device (manufacturers, notified bodies, authorities, etc.).
To meet these objectives, the European Commission has decided that Eudamed should have 2 basic tools:
- A database comprising 6 modules
- A website that allows users to search the database and, for manufacturers and authorities, to add or amend product information
Given the complexity of the project, a timetable has also been drawn up for the roll-out of the six modules between 2020 and 2022. And although, as things stand, we do not know for certain when all the modules will be operational, we do know which ones they are and which ones are already up and running. Would you like to know the current situation? Read on.
The six modules that make up the Eudamed database
The six modules that make up the Eudamed medical device database are:
- Actors’ Register (ACT) (active since December 2020)
- UDI/Product (UDID) Registration (in force since September 2021)
- Notified and Certified Bodies (CRF) (active since September 2021)
- Clinical and performance studies (CIPS)
- Post-marketing surveillance and monitoring (VGL)
- Market Surveillance (MSU)
As can be seen, 3 of the 6 modules are already active, and the rest are expected to be active between 2022 and 2023. For the time being, data uploads to the active modules are not yet mandatory: those responsible for registering medical devices do so on a voluntary basis. However, this situation will change once all the modules are active and Eudamed is officially launched.
Therefore, and in line with the advice issued by European health authorities – including the AEMPS – we would like to offer the following recommendations to medical device companies:
- Start uploading information to the three operational modules straight away, so that we can see how this new tool works and to prevent a large backlog of work from building up once it becomes mandatory.
- Keep an eye on announcements from the official authorities (the European Commission and the AEMPS) to obtain first-hand information on the publication of the remaining three modules and the official launch of Eudamed.