Introduzione

MedDev Day 2025 – Shifting Mindsets: The Future of Global Medical Device Regulation

How Regulatory Changes Are Reshaping Global Business Strategies

Regulatory approaches across the EU, the USA, and many other regions worldwide are evolving, requiring companies relying on these markets to adapt to increasingly stringent requirements.

Join MedDev Day 2025 to discover the latest regulatory updates, with a focus on the EU, USA, Asia, and MEA. Learn how to maintain a competitive edge, ensure compliance, and foster innovation in the medical device sector.

What to expect at MedDev Day 2025:

In-depth analysis of new regulatory frameworks and specific pathways (e.g., orphan devices and Scientific Advice procedures).
A focus on the value of real-world evidence (RWE) in pre- and post-market strategies, covering data quality and relevance.
A workshop session on Artificial Intelligence and Machine Learning to explore benefits and challenges in quality, regulatory, and clinical environments.
An overview of the appeal of various regulatory contexts, with particular attention to technological and sustainable solutions.
Opportunities to network with industry professionals (manufacturers, notified bodies, competent authorities) and develop practical strategies to boost operational efficiency.

This seventh edition, held over one and a half days, will highlight how cost and technology factors drive the evolution of the regulatory landscape, offering methodologies and best practices to guide your business decisions. Dedicated sessions on real-world case studies will demonstrate how to manage documentation effectively and promote evidence-based decision-making.

Scientific board

Bassil Akra, Chief Executive Officer at AKRA TEAM
Arkan Zwick, Corporate Director Regulatory Affairs at CROMA Pharma

Who should attend?

MedDev Day 2025 is aimed at medical device professionals from Regulatory Affairs, Quality, Clinical Operations, Medical Affairs, Post Marketing Surveillance departments working in Pharmaceutical, Biotechnology and Medical Device companies, CROs, Universities/Hospitals, Academic Research, Patient Associations and Healthcare Organisations, Competent Authorities, EU Commission and Regulatory Authorities.

Join us in Budapest on 13 -14 October 2025 to stay up to date with regulatory changes, forge valuable connections, and develop winning strategies in the medical device world.

Register now and help shape the future of regulation.

Quote di iscrizione

€ 670,00 Early Bird fee until 15 September 2025
€ 790,00 Ordinary fee
€ 480,00 Freelance, Individual, Academy, Public Administration

Fee includes: seat at the conference, pdf copy of presentations of Speakers who allow the distribution, networking lunch, coffee breaks, organisational office assistance, certificate of attendance.

Informazioni utili

The conference will take place at:

NH Budapest City
Vígszínház u.3 – 1137 Budapest

The NH Budapest City hotel is in the Újlipótváros business district on the Pest side of the river. Some of Budapest’s star attractions are right on the doorstep, and the nearby metro station whisks you to more tourist hotspots.

From the airport
Taxi: it´s a 40 minutes trip.
Bus: you can take the bus line 200 from the Airport Budapest, station “Repüloter, P+R” to get to the station “Kobanya-Kispest”. From there take the metro line M3 (blue line) for the station “Nyugati Palyaudvar”. You can reach the hotel in a walking distance from about 5 minutes.

From the train station
From Nyugati Station: exit the station and turn right for the street “Szent Istvan Krt”. From there please turn right again for the street “Hegedüs Gyula”. Afterwards please turn left for the street “Vigszinhaz”. The hotel is located on the right.
Closest metro station: Nyugati Palyaudvar (M3-blue line).