In a recent article we have reported that the EUDAMED economic operator registration module will be available as of December 2020.
The corresponding registration will trigger the assignment of a Single Registration Number (SRN). Without an SRN, manufacturers, authorized representatives and other economic operators won’t be able to operate in EUDAMED. Furthermore, economic operator registration is a requirement also for manufacturers that will continue to place their products on the market under the medical devices directive (MDD) beyond May 26, 2021.
Although the registration deadlines apply once EUDAMED becomes fully functional, mdi Europa thinks it is highly recommendable to apply for an SRN as early as possible.
According to Regulation (EU) 2017/745 on medical devices (MDR), an economic operator must prepare the following details as per section 1 of part A of annex VI:
- type of economic operator(manufacturer, authorised representative, or importer,
- name, address and contact details of the economic operator,
- where submission of information is carried out by another person on behalf of any of the economic operators mentioned under Section 1.1, the name, address and contact details of that person,
- name address and contact details of the person or persons responsible for regulatory compliance referred to in Article 15.
Read our full article “EUDAMED economic operator registration module available as of December 2020“.
Do you require additional details or assistance with obtaining the SRN? Then please get in touch with our team!
Source: MDCG guidance, MDR