Eudamed will be delayed by at least two years. However, upon pressure by local country authorities, the European Commission wants to permit early access to SRN before Eudamed launches in 2022 to temporarily facilitate voluntary registration. Economic operators can decide if they want to register in Eudamed’s new actor registration module, which should be available by 26 May 2020. The aim is to harmonise register procedures as soon as possible in light of the delay in launching the Eudamed 3 database.
The SRN is a code for instant recognition of every economic operator in the EU. It seems that some EU member states are currently assessing to what degree they can use the SRNs in their national systems short-term.
In keeping with the Regulation (EU) 2017/745 on medical devices (MDR), manufacturers have to apply for the SRN no later than six months after notice is published in the OJEU declaring that Eudamed is fully operational. That deadline is currently likely to be 26 November 2022. However, the MDR will be fully implemented on time on 26 May 2020, without Eudamed. It is understood that the Commission is preparing a guidance to explain the practical sides of the postponement of Eudamed 3.
Source: Medtech Insight (an Informa product)