About

As the European medical devices regulations (MDR) enters its third year of application, the industry is striving to comply with MDR compliance in a challenging economic and regulatory environment.

As first movers approach their recertification dates, other companies are achieving their initial product and quality system certifications, while some industry players are still in the application phase to meet the transitional requirements.

At the same time, the regulatory system is scrutinised to see how it delivers on its promises of better regulation, less burdensome requirements, and competitiveness and attractiveness in a global perspective.

This year’s MedDev Day will focus on the attractiveness of the European regulatory landscape for medical devices, improvements made and future developments.

Delegates will get practical insights on:

  • how to meet MDR requirements and cost of compliance,
  • the comparison of the European system to other regulatory regimes and global regulatory and clinical strategy
  • how to streamline and cost effectively meet post market obligations
  • how to achieve recertifications in a least burdensome approach
  • how to minimize efforts for phasing out MDD/AIMDD and how to successfully shift to MDR as for transition delegates
  • latest developments on the regulation, EUDAMED and clinical standards

The one-and-a-half-day program features Industry and competent authority talks followed by interactive workshops to allow elaborate solutions for post market programs and clinical strategy.

Scientific Board:

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


Who should attend?

The conference 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.

Programme

07 October 2024 from 13:00 to 17:00
08 October 2024 from 8:30 to 17:00

Programme work in progress. Timetables subject to change.

07 October 2024
OPENING PANEL DISCUSSION | Legislation on Different Perspectives: Regional Update
Amra Racic - Sr. Director Global Government Strategy MedTech at Veeva Systems
Daniel Delfosse - Vice Director and Head of Regulation & Innovation at Swiss Medtech

More speakers TBA

WORKSHOP SESSION | European Challenges and Opportunities

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

Interactive session involving working in groups: an opportunity to foster collaborative discussions, encourage diverse perspectives and facilitate the exchange of ideas.

08 October 2024
Medical Device Software: US vs EU paths to market
Elizabeth Gfoeller - Corporate Director, Regulatory Affairs at MED-EL

Software medical devices present increasing challenges to regulatory professionals in determining a straightforward regulatory path to market.

Between challenges of cybersecurity, AI considerations, pre and post market clinical data requirements, how to handle service releases and changes post approval, vigilance expectations of authorities etc. no market approval and maintaining that approval is easy.

This session provides some tips on how to best determine and prepare the right regulatory strategy and how to navigate high risk software to approval in the EU and US context?

US 510(k) versus EU MDR submission
William Lory - Regulatory Affairs Manager EMEA at Sirtex Medical

Exploring the characteristics and key differences between both regulatory pathways to help selecting strategies and optimize product approval.

Is the European device regulatory system still attractive and competitive?
Arkan Zwick - Corporate Director Regulatory Affairs at Croma Pharma

Since the MDR fundamentally revised the European system for medical devices it aimed to establish a transparent and predictable system for devices while supporting innovation, smooth functioning of the internal market and promote global convergence and trade.

Three years after its date of application industry has gained experience in working within the revised environment and achieving MDR conformity assessments and quality management system compliance.

These efforts required significant industry investments and are done in difficult macroeconomic trends of high inflation, constrained capital markets, uncertain supply and rising geopolitical tensions.

In this environment and seven years after MDR publication industry questions whether the MDR has improved the regulatory system and whether the regulation delivers on its objectives.

The presentation will critically assess the progress made towards transparency, predictability, innovation, internal market and global trade from a legal and systems perspective by comparing MDR requirements to good practices from other regulations such as medicinal products or global regulatory processes such as PMA to assess whether the European system has improved.

The presentation will also illustrate needed enhancements from an industry perspective to potentially be included in next revisions of the regulatory system.

Speakers
Bassil Akra
Info Scientific Board

Bassil Akra

Chief Executive Officer at AKRA TEAM GmbH

Dr. Bassil Akra is CEO and Owner of AKRA TEAM GmbH, a consultancy company which was founded in 2021 to support the various stakeholders in the healthcare system achieving their target in a highly regulated business area. He spent the last year consulting and supporting medical device, in-vitro diagnostic, combination device companies preparing their strategy for the EU regulations MDR 2017/745 and IVDR 2017/746. Before that, he spent many years as a subject matter expert at the biggest notified body in Europe acting in the various roles and representing locally and globally the notified body association in the various European discussion and guidance documents preparation. Dr. Akra was the Vice President of Strategic Business Development at the Global Medical Health Services of TÜV SÜD Product Service GmbH. He has long experience in leadership, business management, research, development, quality management, and regulatory approval of medical devices, combination devices, and ATMP Products. Dr. Akra played an essential role during the implementation of the medical device regulation in Europe. He was also involved in the drafting of several European guidance documents (e.g. MEDDEV, MDCG, etc.) and International Standard. He spent the last years of his career at TÜV SÜD training and educating the various stakeholders on the EU Legislations (e.g. MDD/AIMDD, MDR and IVDR), supporting their implementation towards achieving the relevant designation ensuring continuity of the healthcare system in the interest of the patient population.

Arkan Zwick
Info Scientific Board

Arkan Zwick

Corporate Director Regulatory Affairs at Croma Pharma

Arkan has a master’s degree in law and PhD in European law. His role includes regulatory strategy, advice and advocacy for drug, devices, and combinations product projects as well as in house legal advice for contract management and due diligence projects. His responsibility includes global regulatory compliance and regulatory market access in the EU, Americas and Asia-Pacific for devices and combination products in ophthalmology, orthopedic and aesthetic medicine. Arkan is lecturer and trainer at the University of Applied Sciences in Lower Austria and on life cycle conferences and trainings. He is fluent in English, German, French and Turkish.

Daniel Delfosse
Info Speaker

Daniel Delfosse

Vice Director and Head of Regulation & Innovation at Swiss Medtech

Daniel Delfosse, Dr.sc.techn., is Vice-Director and Head of Regulation & Innovation at the industry association Swiss Medtech. His mantra is “innovation despite regulation” and he pursues the goal of keeping Switzerland an attractive location for the medtech industry.
Daniel graduated from ETH Zurich as a materials engineer and did his doctorate at EPF Lausanne. After a research stay at the University of British Columbia in Vancouver, Canada, he moved to the medtech industry. For almost 20 years he worked as head of development and member of the executive board for a Swiss orthopaedics company, always at the crossroads between regulation and innovation

Elizabeth Gfoeller
Info Speaker

Elizabeth Gfoeller

Corporate Director, Regulatory Affairs at MED-EL

Elizabeth Gfoeller is the Corporate Director of Regulatory Affairs of MED-EL, an EU medical device manufacturer headquartered in Innsbruck, Austria.
Joining MED-EL in 2006, she currently leads the Corporate Regulatory Affairs function which has global responsibility for product licensing, registrations, re-certifications, post-market vigilance activities, regulatory strategies for new product developments and related compliance activities internally within MED-EL and externally to new and changed regulations and standards.

William Lory
Info Speaker

William Lory

Regulatory Affairs Manager EMEA at Sirtex Medical

William Lory, Pharm. D. is Regulatory Affairs Manager EMEA at Sirtex Medical whose mission is to improve the quality and longevity of patients’ lives by providing innovative interventional oncology solutions. 10+ years of experience in medical device regulatory affairs with multiple submissions at global scale and more specifically according to the Medical Device Regulation (EU) 2017/745.

Amra Racic
Info Speaker

Amra Racic

Sr. Director Global Government Strategy MedTech at Veeva Systems

Amra is the Sr. Director of Global Government Strategy for MedTech at Veeva Systems. She has been in the Healthcare Industry for over 23 years, and most of those spent in large medical device companies in a variety of regulatory roles. In addition to Abbott and Bayer, she spent 13 years at Medtronic working on global regulatory advocacy, global strategy and global regulatory intelligence, which allowed her to represent the organization in a number of external working groups and hold various chair, co-chair and SME roles. In addition to her day job, she finds time to teach International Regulatory at a local University in MN and also serves on the board of a non-profit called WISE (Women initiatives for self empowerment) focused on ensuring young women in underserved and immigrant communities understand healthy relationships and have opportunities to finish schooling.

Erik Vollebregt
Info Speaker

Erik Vollebregt

Partner at Axon Lawyers

Biography available soon

Contacts

Valeria Quintily
Sr. Scientific Project Manager
valeria.quintily@lsacademy.com

Ilaria Butta
Events and Training Manager
ilaria.butta@lsacademy.com


Registration Fee

€ 670,00 Early Bird fee until 09 September 2024
€ 790,00 Ordinary fee
€ 430,00 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.


Useful Information

The conference will take place at:

Hotel Scandic Copenhagen
Vester Søgade 6, Copenhagen – Denmark

Centrally located, 500 metres from Copenhagen Central Station, this contemporary hotel offers stunning views of the lakes and the Copenhagen skyline. From Copenhagen Airport: only 12 km by car. By public transport (via metro or bus), journey time around 25-minutes.

Past Conferences
2023
Attractiveness of the EU market with the MDR. Where the Regulation stands - what is next?
2022
MDR 2017/745 Reality Check – Readiness of the EU System
2021
MedDev Day 2021
2020
MedDev Day 2020
2019
MedDev Day 2019
Register
Early Bird
Available until 09/09/2024
670,00
Ordinary
Available until 06/10/2024
790,00
Freelance – Individual – Academy – Public Administration
Available until 06/10/2024
430,00
Clear

Printable Version
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<p style="text-align: center;"><strong>Hotel Scandic Copenhagen<br />
</strong>Vester Søgade 6<br />
Copenhagen &#8211; Denmark<strong><br />
</strong></p>

Hotel Scandic Copenhagen
Vester Søgade 6
Copenhagen – Denmark

<p style="text-align: center;"><strong>Hotel Scandic Copenhagen<br />
</strong>Vester Søgade 6<br />
Copenhagen &#8211; Denmark<strong><br />
</strong></p>
<p style="text-align: center;"><strong>Hotel Scandic Copenhagen<br />
</strong>Vester Søgade 6<br />
Copenhagen &#8211; Denmark<strong><br />
</strong></p>
<p style="text-align: center;"><strong>Hotel Scandic Copenhagen<br />
</strong>Vester Søgade 6<br />
Copenhagen &#8211; Denmark<strong><br />
</strong></p>