The CataloniaBio & HealthTech Regulatory Affairs Workgroup (WG) hosted its fifth Hard Reg Café, on 7 February at the Barcelona Science Park, focusing on the new European database on medical devices (EUDAMED) with expert Richard Houlihan. Many medical technology companies and start-ups in Catalonia were interested in the session, which brought together more than 50 professionals after reaching capacity just days after the first announcement.
The presentation was led by WG coordinators and CataloniaBioHT board members Lidia Cánovas (Asphalion) and Lluís Chico (NEOS Surgery).
“The European Committee will launch EUDAMED in May 2022, without any more delays, but what we don't know is whether all the modules will be working,” clarified Houlihan. EUDAMED aims to oversee the safety and performance of devices, as per the medical devices regulation (MDR) and the in vitro devices regulation (IVDR), and applies to both manufacturers and importers.
Houlihan, who currently heads up the EudaMed consultancy firm in Brussels, recommended companies prepare their teams, study the requirements, invest in training, prepare basic UDI groups (Unique Device Identification) and start localising the data. “EUDAMED is more complex that the US Food and Drug Administration's UDI. We can't be caught off guard,” he added.
If you're a CataloniaBioHT member and would like to receive the documents from the Hard Reg Café session, write to ismael.avila@cataloniabioht.org.
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