The Hard Reg Cafe is back for its 12th edition, with one of the topics that raises the most questions in the sector: the MDR and IVDR, and the changes now being proposed.

Catalonia.health is organising an in-person session to understand what is changing, where the regulation currently stands and what industry and all the actors involved should expect. We will welcome Erik Vollebregt, a life sciences and intellectual property lawyer at Axon Lawyers, involved in the MDR and IVDR targeted revision process in various ways. He will open the day with the keynote "What is changing in MDR and what should industry expect?".

A strategic roundtable and an expert panel will follow, with plenty of time for your questions. In the afternoon, a 2-hour workshop with Vollebregt, with limited places.

Speakers:

• Erik Vollebregt, Life Sciences and IP lawyer at Axon Lawyers. Keynote speaker.

• Expert panel: (to be confirmed).

Programme (provisional schedule)
8:45 Registration
9:00 Welcome
9:15 Keynote: What is changing in MDR and what should industry expect?, by Erik Vollebregt.
10:00 Coffee and networking
10:30 Strategic roundtable: current and future impact on the ecosystem, with a discussion on the business implications and innovation brought by the MDR/IVDR counter-reform.
11.30 Expert panel: previous experiences and what to do from now on.
12:30 End of the morning session

Lunch

14:30 Workshop (2 hours) with Erik Vollebregt at the Barcelona Science Park (PCB). Limited places

Aimed at: medical device and digital health companies and start-ups, consultancies, regulatory managers and any health sector professional who wants tokeep up to date with the MDR and IVDR.

Language: English

Registration:

• Catalonia.health members: free

• Non-members of Catalonia.health: €50 (VAT not included)

Enquiries: Roser Alba (Project Coordinator) · roser.alba@catalonia.health

What are the Hard Reg Cafes?
They are working sessions to share concerns on regulatory matters, discuss topics of interest or bring a prestigious guest from this strategic field to the companies and start-ups of Catalonia.health.

This is the 12th edition of the Hard Reg Cafe. You can browse all previous sessions here.

With the support of: