WHAT IS EUDAMED?
- EUDAMED is an information system that was established by the Regulation (EU) 2017/745 on medical devices and the Regulation (EU) 2017/746 on in vitro diagnostic medical devices, and developed by the European Commission.
- It enhances transparency and the harmonisation of information on medical devices available on the EU market.
- It is a web portal for the exchange of information between economic operators, national competent authorities, notified bodies and the European Commission.
Information on the development of EUDAMED on European Commission’s website can be accessed here.
On 26 November, the COMMISSION IMPLEMENTING REGULATION (EU) 2021/2078 of 26 November 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the European Database on Medical Devices (EUDAMED), which is binding in its entirety and directly applicable in all EU Member States.
WHAT DOES EUDAMED CONSIST OF?
Clinical investigations and performance studies
Vigilance and post-market surveillance
1. ACTOR REGISTRATION MODULE
On 1 December 2020 the first module, i.e. the Actor registration module, went live and is intended for:
- authorised representatives,
- manufacturers of systems and procedure packs
to register and obtain a single registration number (SRN).
Registration in the national Register of economic operators established in the Republic of Slovenia that carry out activities in the field of medical devices is necessary for the confirmation of the economic operator in EUDAMED. After the verification of information by JAZMP in accordance with Article 31 of the Regulation (EU) 2017/745, the economic operator is assigned a SRN through EUDAMED.
To facilitate registration for Slovenian economic operators, we prepared a document with frequently asked questions and answers (FAQ).
2. UDI/DEVICES REGISTRATION MODULE
At the end of 2021, the UDI/Devices registration module was published by the European Commission.
The Regulation (EU) 2017/745 on medical devices (MDR) and the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establish an EU system for the identification of devices based on the unique device identifier (UDI), improving traceability of medical devices. When EUDAMED is fully functional, manufacturers will have to enter all required information into the database for all devices they wish to put on the EU market. Registration of devices in the UDI module is currently carried out on a voluntary basis. The regulations stipulate that the registration of devices to EUDAMED will be obligatory after the notice that EUDAMED is fully functional has been published in the Official Journal of the European Union. After this publication, there will be an 18-month transitional period for manufacturers to register their devices in EUDAMED.
For traceability and market oversight reasons, each EU Member State adopted national provisions regarding the registration for the transitional period.
Clarifications and instructions for the registration of devices in the UDI registration module are available here.
3. NOTIFIED BODIES AND CERTIFICATES MODULE
The Notified bodies and certificates module also went live.
The Regulation (EU) 2017/745 on medical devices (MDR) and the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) stipulate that notified bodies (NB) must enter all information into EUDAMED regarding issued certificates (including changes and updates), and suspended, reinstated, withdrawn or refused certificates, including all restrictions of a given certificate. Information on issued certificates in EUDAMED will be made available to the general public.
Until EUDAMED is fully functional, the European Commission cannot demand that the Notified bodies and certificates module be used. The entry of certificates into EUDAMED by NBs is already possible, but only on a voluntary basis and if the participating economic operators have already registered in EUDAMED. The regulations allow EU Member States to adopt national provisions for the transitional period.
Clarifications and instructions regarding the Notified bodies and certificates module are available here.
Until EUDAMED is fully functional, i.e. until the notice of its full functionality is published in the Official Journal of the European Union, registration in EUDAMED is not obligatory. Furthermore, the regulations introduce a transitional period for registration:
- 6 months after the notice that EUDAMED is fully functional has been published in the Official Journal of the European Union, the registration of economic operators in EUDAMED is required, and
- an additional 18 months for the registration of all devices into the UDI/Device module.