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
13:00
13:30
Registration
13:30
13:40
Welcome by the Scientific Board
13:40
15:00
OPENING PANEL DISCUSSION | Legislation from Different Perspectives: Regional Update
Daniel Delfosse - Vice Director and Head of Regulation & Innovation at Swiss Medtech
Martin Penver - Team Leader for product assessment at TÜV SÜD Denmark
Monisha Phillips - Head of Certification Body (MHS UK) at TÜV SÜD
Amra Racic - Sr. Director Global Government Strategy MedTech at Veeva Systems
Nebojsa Serafimovic - Assessor for Clinical Investigations with Medical Devices at AGES/BASG
15:00
15:30
Coffee break
15:30
16:45
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.

16:45
17:00
Wrap-up Day 1
08 October 2024
08:45
09:00
Start Day 2
09:00
09:40
Manufacturer´ Experience with EU MDR Implementation
Glenda Marsh - Head of EU Regulatory Affairs at Johnson & Johnson

The presentation will cover the following topics:

  • Being an early adopter and adapting to evolving requirements and expectations
  • Experience with multiple NBs across a large portfolio
  • Managing WW registration impact
  • Moving from implementation to sustaining life-cycle
09:40
10:20
Switzerland and UK: New Requirements and Challenges from an Authorised Representative/Manufacturer’s Perspective
Larissa Piñon Ferreira - Regulatory Affairs Manager at Becton Dickinson

In the past, the CE mark served as a passport for medical devices to access markets across the European Union (EU), United Kingdom (UK), and Switzerland. However, recent changes—Brexit in 2020 and the lack of an updated Mutual Recognition Agreement between the EU and Switzerland in 2021—have altered this landscape. Having the CE mark alone is no longer sufficient for the UK and Swiss markets. Manufacturers must now navigate additional requirements specific to each country/region.

In this session we will explore the current medical device requirements for the UK and Swiss markets, examining the challenges faced from both the manufacturer and authorised representative’s perspective.

10:20
10:50
Coffee break
10:50
11:30
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?

11:30
12:10
Navigating the MDR Maze: Pragmatic Post-Market Surveillance
Markus Pöttker - Director, Global Post-Market Surveillance at Smith&Nephew

The presentation will cover the following topics:

• Decoding MDR post-market surveillance requirements
• Essential steps to ensure compliance and meet new regulatory demands without overburdening resources
• Challenges and considerations for PMS practices for legacy devices

12:10
12:20
Q&A Session
12:20
13:20
Networking Lunch
13:20
14:20
INTERACTIVE SESSION | New, newer, newest - Recommendations of and Musings about Future Evolutions or Improvements of the Regulatory System
Erik Vollebregt - Partner at Axon Lawyers

The EU keeps tweaking the MDR and the IVDR to fix transitional issues. But the Commission has announced that a targeted review is in the works. And there may be more underway!

This session will cover all new requirements (the January 2024 proposal), the newer requirements (what could the Commission want in a targeted review?) and the newest requirements (what else may be in the pipeline that is not so visibile yet?).

14:20
14:50
Coffee break
14:50
15:30
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.

15:30
16:10
Is the European Device Regulatory System Still Attractive and Competitive?
Arkan Zwick - Corporate Regulatory Affairs Director at CROMA Pharmaceutical, Austria

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.

16:10
16:20
Closing Remarks by the Scientific Board
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 Regulatory Affairs Director at CROMA Pharmaceutical, Austria

Mr. Arkan Zwick is the Corporate Regulatory Affairs Director of CROMA Pharma, Austria. CROMA is a private global pharmaceutical and surgical company with products in ophthalmology, orthopedic and aesthetic dermatology. With more than sixteen years of regulatory professional experience Arkan´s role includes regulatory advocacy for drug, medical device, combi products and cosmetic compliance projects as well as in house legal advice for contract management, merger and acquisition, and intellectual property projects. He is responsible for the company’s regulatory compliance in the EU working with several notified bodies and for global market authorizations in the Americas and Asia-Pacific.Arkan has a master’s degree in Law from the University of Vienna and a PhD in European Law. His expertise includes in house legal and regulatory consulting as well as lecturing at the University of Applied Sciences in Vienna and scientific board member and speaker on life cycle conferences and trainings. He is fluent in English, German and French.

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.

Glenda Marsh
Info Speaker

Glenda Marsh

Head of EU Regulatory Affairs at Johnson & Johnson

Glenda Marsh is a corporate executive with over 20 years of global experience in regulatory affairs, program management and operations across the health-care industry, including medical devices, biotech and consumer products.

Since joining Johnson & Johnson in 2001, she has held positions of local, regional, and global responsibility and covered different J&J sectors, business units, functions and regions (North America, Latin America and EMEA). She has led regulatory programs from concept to approval and implementation spanning the entire medical device product lifecycle.

Glenda has extensive experience in leading large organizations through major regulation changes, with a focus on building organizational capabilities and ensuring continued and timely patient access to life-saving medical technology. Since 2016, Glenda has played a strategic leadership role in the preparation for and implementation of the EU MDR (Medical Device Regulation), and more recently, UKCA and Swiss MedDO, ENVI requirements, for all J&J MedTech companies.

Currently, Glenda leads Regulatory Affairs in EU markets ensuring successful execution of the global innovation agenda as well as life cycle maintenance of an extensive medical devices portfolio.

Glenda has a master’s degree in chemical engineering from Stevens Institute of Technology and a bachelor’s degree in chemical engineering from the University of Sao Paulo.

Martin Penver
Info Speaker

Martin Penver

Team Leader for product assessment at TÜV SÜD Denmark

Martin Penver is the Team Leader for product assessment at TÜV SÜD Denmark ApS, MDR notified body CE2443.
Using his experience gained from working within Notified Bodies for the past 14 years, he has helped implement streamlined procedures to improve conformity assessment activities in terms of transparency, timelines, predictability, and consistency. He has represented several Notified bodies at European discussions on the MDR requirements and helped draft technical information and regulatory guidance between a notified body and a manufacturer.
At TÜV SÜD Danmark ApS, he has created structured dialogues with manufacturers as part of the normal pre-application activities, and written guidance on how manufacturers can complete self-assessments for a smoother and faster process to avoid incomplete applications to the notified body.

Monisha Phillips
Info Relatore

Monisha Phillips

Head of Certification Body (MHS UK) at TÜV SÜD

Biography available soon

Larissa Piñon Ferreira
Info Speaker

Larissa Piñon Ferreira

Regulatory Affairs Manager at Becton Dickinson

Larissa is the Regulatory Affairs Manager at Becton Dickinson and Company (BD), one of the largest global medical technology companies. Larissa’s journey began by working with quality management systems. About five years ago, she transitioned to the medtech industry, where she found her passion. In 2020, she joined BD, where she now leads the EU Authorised Representative and Swiss Authorised Representative team. Larissa has been involved in developing and implementing the activities for these entities, new processes and team, ensuring compliance with the Medical Device Regulation (MDR), in vitro Diagnostic Regulation (IVDR), and the new Swiss ordinances, MedDO and IvDO.

Markus Pöttker
Info Speaker

Markus Pöttker

Director, Global Post-Market Surveillance at Smith&Nephew

Markus holds the position of Director of Global Post-Market Surveillance, overseeing global PMS teams for the Orthopaedics, Sports Medicine and Advanced Wound Management business units at Smith+Nephew, a leading global medical technology company. In his previous role within the EU MDR Project team, Markus led the Post-Market Surveillance work stream. In this capacity, Markus ensured the accurate interpretation and implementation of EU MDR requirements throughout the organization.
With a background in law specializing in information law, Markus is deeply passionate about data. He endeavours to transition from traditional document-centric work to more data-driven methodologies. Markus is a founding member of MDKU e.V. and currently serves as the co-chair of MedTech Europe’s PMS & Vigilance Working Group. Additionally, he contributes his expertise as a member of the MDCG Task Forces for Vigilance, PSUR, and PMS, showcasing his dedication to advancing post-market surveillance in the medical technology sector.

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.

Nebojsa Serafimovic
Info Speaker

Nebojsa Serafimovic

Assessor for Clinical Investigations with Medical Devices at AGES/BASG

Mr Nebojsa Serafimovic is an assessor for clinical investigations with medical devices and performance evaluations with in vitro diagnostics at the AGES/BASG. Besides approving studies he is involved in the development of national processes to tackle MDR and IVDR requirements. Prior to his work at the Competent Authority, Nebo worked for Philips Austria in the field of medical device engineering and the Medical Response Center. He studied Biomedical Engineering at Graz University of Technology and at the TGM in Vienna. Nebo is member of the Clinical Investigation and Evaluation Working Group, contributes in a number of taskforces and is lead of the EUDAMED oversight board CIPS module.

Erik Vollebregt
Info Speaker

Erik Vollebregt

Partner at Axon Lawyers

Erik specialises in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software and protection of personal data. He is an expert in life sciences regulation at EU and Dutch level, with a focus on contracts, regulatory litigation against competent authorities and M&A. Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms.

He actively contributes to law and policy development at national and EU level via membership of specialized committees at branch associations and the European Commission. Erik also works as arbitrator in medical devices related disputes and is regularly retained as expert witness in foreign litigation.

Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish.

Chambers Europe 2017 about Erik:

He is known for his specialism in regulatory work, which covers medical technology, devices and products as well as biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience”.

Sponsors

 

Would you like to become a Sponsor?
Please contact us to receive more information about the sponsorship offers
and which benefits they include.

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
€ 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.


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
Printable Version
Contact us to receive more information about the sponsorship offers
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Sponsors

<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>