What is EUDAMED?
In 2017, the European Commission issued two new regulations: the regulation on medical devices 2017/745/EU (MDR), and the regulation on in vitro diagnostic medical devices 2017/746/EU (IVDR). The last 20 years have seen a great deal of progress in the fields covered by these regulations. So it was a good time to look at the targets achieved to date, adjust key elements and make the content more transparent for everyone involved – from manufacturer to patient.
The MDR will replace the existing medical device regulation (93/42/EWG – MDD) and the guideline on active implantable medical devices (90/385/EWG – AIMDD). An important point: In contrast to EU directives, European regulations do not have to be transferred to national law. This means that the regulation is implemented uniformly across all EU member states.
The MDR was issued in May 2017. This marked the starting point of a three-year transition phase, during which the new medical product regulation will be replacing the AIMDD und MDD. The MDR applies from May 2020, although actors are free to begin aligning their activities with the regulation immediately. The new MDR-compliant data must be uploaded by November 2021. While the MDR will be in force as soon as May 2020, the IVDR will only come into effect in 2022. All actors involved with medical devices are now called upon to align their activities with these two regulations.
What changes will you see?
When a directive becomes a regulation, people often talk of new requirements rather than changes. That’s because the regulation is adhering to the same course. In the case of the new medical devices regulation this means that requirements to date remain in place, but they are simply joined by new requirements. Here are some of the key points:
- Introduction of a new, unique identification system (UDI – unique device identification)
- Designation of a person who is responsible for compliance with standards.
- Designation of a representative if the manufacturer is located outside the EU (authorised representative).
Where exactly does EUDAMED come in?
It is now clear that identification of authorised devices is one of the main tasks of the new regulations. Naturally this involves large volumes of data. To ensure the quantity, quality and proper administration of this data, the European Database on Medical Devices (EUDAMED) was established. To ensure the quantity, quality and proper administration of this data, the European Database on Medical Devices (EUDAMED) was established. The database is an internet portal in which manufacturers are responsible for entering and maintaining data on their own devices.
The key dates to note
Keep an accurate overview of the coming milestones with the key dates and facts here (as at August 2019).
Where are we now?
A lot has happened since May 2017. So for some points we can already offer concrete statements:
- An extension of 18 months was granted for product registration. But there are some exceptions here, primarily related to clinical monitoring and patient safety (by 11/2021).
- Upon activation, EUDAMED will not be fully operational. Using a roadmap, participants can get a precise overview of timing for implementation, with four releases planned:
– High (1): first release, March 2020
– High (2): second release, November 2020
– Medium (3): third release, May 2021
– Medium (4): fourth release, May 2022
– Low (5): later release (not for audit)
- atrify is actively involved in exchange between manufacturers, the European Commission and MedTech Europe. MedTech represents the medical technology industry.
- atrify is working on the AS4 connection and is currently preparing the XML file which will serve as the basis for communication with EUDAMED.
We are very excited to witness how implementation is progressing. We know how important this process is for all involved and look forward to seeing the next steps. We also recognise that compliance with the MDR represents a challenge for manufacturers. That’s why we’re doing everything we can to offer targeted solutions that support manufacturers.
As you know, this is just the beginning of the EUDAMED story. So we will be keeping you up to date in the future, providing regular updates on changes, innovations and enhancements.
Learn more about our EUDAMED solution.