EUDAMED obligation for modules 2 and 3 postponed by one year
23 July 2022
The EUDAMED database was developed and introduced by the European Commission as an integral part of the implementation of Regulations (EU) 2017/745 for medical devices and (EU) 2017/746 for in-vitro diagnostics. EUDAMED intends to use the information to provide a picture of the life cycle of medical devices that are made available in the European Union (EU) and improve access to this information. 6 linked modules and a public website form the framework of EUDAMED:
- Registration of economic operators
- UDI/Device Registration
- Notified bodies and certificates
- Clinical investigations and performance studies
- Vigilance and post-market surveillance
- Market Surveillance
Since the Regulation (EU) on Medical Devices 2017/745 (MDR) came into force on 26th May 2021, as well as the Regulation (EU) 2017/746 for in-vitro diagnostics on 26th May 2022, all economic operators (manufacturers, authorized representatives, importers) are required to register in the new European database for medical devices (EUDAMED) to receive their “SRN”, the Single Registration Number (Module 1). The SRN is the prerequisite for all further activities in EUDAMED.
Modules 2 and 3, “UDI/Device Registration” and “Notified Bodies and Certifications”, are currently available for voluntary use. In the event of serious incidents in the market, however, the relevant information must be entered immediately for the products in question.
The remaining modules 4, 5 and 6, “vigilance”, “clinical studies and performance studies” as well as “market surveillance” are still partially under development or validation.
From Q4 2024 on, Module 1 as well as Modules 4, 5 and 6 will be mandatory for all economic operators.
The obligation to submit entries for modules 2 and 3 in EUDAMED has now been postponed by one year from Q2 2025 to Q2 2026.
However, we would like to draw your attention to the document MDCG 2019-5, which should be followed with regard to “legacy devices” and their registration in EUDAMED, under the conditions specified there.