The CataloniaBio & HealthTech Regulatory Affairs Workgroup is holding its fifth Hard Reg Café meeting on 7 February in Barcelona. The event will feature a training session to help start-ups and companies understand the new European database for medical devices (EUDAMED). The European Commission will launch EUDAMED in 2022 to monitor the safety and performance of devices under the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR).

Welcome by CataloniaBioHT board members Lidia Cánovas, general manager of Asphalion, and Lluís Chico, managing partner of NEOS Surgery.

Keynote Speaker: Richard Houlihan, CEO at EudaMed (Belgium)

PROGRAMME

Capacity: limited spots

Language: English

Registration fees:

• CataloniaBioHT members: free (first two from each company; third person on must pay full rate)
• Non-members: €50 (VAT not included). You will be invoiced €50/person

UPDATE 3 FEBRUARY: Sold out. If you are interested to participate, please send us an email to ismael.avila@cataloniabioht.org.

Richard Houlihan

Richard Houlihan is a world renowned speaker on the European database for medical devices (EUDAMED) and CEO at EudaMed, a company that provides EUDAMED spreadsheet templates, support, consulting, and technical and non-technical training for the industry. During his time with the EC, he was responsible for Eudamed 2 and was technical manager for EUDAMED (2017-2019) when he left the EC to return to the private sector. Also, he has worked at IT-related businesses for over 25 years. 

Related news:

Report EUDAMED to go into force in 2022 for European MedTech companies

What is Hard Reg Café?

It is a series of coffee work meetings, held once a quarter, to share concerns regarding regulatory issues, debate topics of interest or bring a prestigious guest in this strategic field for CataloniaBioHT biopharmaceutical, medical technology and digital health start-ups and companies.

Previous meetings:

• 1st Hard Reg Café "Briefing Meeting" 
• 2nd Hard Reg Café "Briefing Meeting"
• 3rd Hard Reg Café "FDA, ODD and Expedited pathways"
• 4th Hard Reg Café: "The new EU MDR"

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