Introduzione

The MDR has been applicable since May 2021.
Over the last years, industry and regulators have made significant efforts to adapt to the Regulation.
Recent improvements are, among others, the number of notified bodies designated under MDR, the preparation and voluntary use of EUDAMED modules, the significant increase of MDCG Guidance documents and the activities and opinions of expert panels for certain high-risk devices.
This is in line with the overall goal of the Regulation to increase the attractiveness of the EU market as well as the quality, safety and performance of devices for patients and consumers.

Despite positive developments, the overall capacity of the regulatory system still needs to be improved.
While manufacturers have concerns about meeting the requirements of the MDR by the end of the transition, the system's capacity needs to be increased to process the number of certificates that need to move from MDD/AIMDD to MDR.

In early 2023, a legislative proposal by the European Commission was published that aims to extend the transition period and validity of certificates under certain conditions to 2027 for high-risk and to 2028 for medium and low-risk devices. This legal proposal is accompanied by supporting non-legislative measures that aim to support notified body capacities, back the industry and ensure the uninterrupted availability of medical devices.

In this dynamic context, the 5th edition of MedDev Day will give you a chance to rest and understand where the regulation stands. The conference will give insight into recent developments impacting MedTech industry and bring representatives from competent authorities, notified bodies and industry to share strategies, best practice solutions and recommendations.

A pre-conference workshop will precede the MedDev Day on Writing the Summary of Safety and Clinical Performance (SSCP): from good to excellent!

The conference will highlight the regulators’ perspective on the MDR state of play, non-legislative support measures, and conditions to be met by manufacturers to benefit from transition provisions and extended certificates. Also, practical insights on how to apply for temporary bridging measures under Article 97 will be conferred.

The MedDev Day will further reveal developments in clinical evaluation consultation opinions and state of play for the voluntary advice to manufacturers on clinical development strategy and clinical investigations. Participants will finally have the opportunity to understand the next steps and an outlook on the future of the regulatory system beyond 2024.

The Scientific Committee:

Scientific Board
Bassil Akra - Chief Executive Officer at AKRA TEAM GmbH
Sabina Hoekstra-van den Bosch - Regulatory Strategy Principal at TÜV SÜD
Arkan Zwick - Corporate Regulatory Affairs Director at CROMA Pharmaceutical

MedDev Day Scientific Coordinator
Laura C Collada Ali - Senior Medical Writer & Scientific Manager at LS Academy

 

Who should attend?
The conference is designed for professionals in the field of Medical Devices, devoted to departments such as:

  • Clinical Operations
  • Product Managers
  • Regulatory Affairs
  • Quality Assurance/Control
  • Risk Management
  • Medical Device Engineering
  • Device Vigilance
  • R&D
  • Medical Affairs
  • Medical Writing

from Pharmaceutical, Biotechnology and Medical Device companies, CROs, Universities/Hospitals, Academic Research, Patient Associations and Healthcare Organizations., competent authorities, EU Commission and Surveillance authorities.

Programma
26 September 2023
09:00
09:30
Registration
09:30
09:40
Welcome from the Scientific Board
09:40
10:25
OPENING PANEL DISCUSSION | Expert Panel: First experience Voluntary and Enforced Consultation
Rob Nelissen - Professor and Chairman department Orthopaedics, Rehabilitation, Physiotherapy at Leiden University Medical Center (LUMC)
Nataliya Deych - Vice President Regulatory Affairs EMEA, Latam, Canada at Edwards Lifesciences
Arkan Zwick - Corporate Regulatory Affairs Director at CROMA Pharmaceutical, Austria

Moderator: Bassil Akra, Chief Executive Officer at AKRA TEAM GmbH

During this session, key subject matter experts with various competence will share insight on the clinical evaluation consultation process and help attendees understanding the key takeaways from the recent publications of the EU Expert Panels.

10:25
11:05
Outlook on the Future of the Regulatory System - an Industry wish list
Christina Ziegenberg - Deputy Managing Director, Head of Regulatory Affairs at BVMed, Berlin

It’s becoming clear that the MDR will not deliver its promise of a “sound, transparent, predictable and sustainable regulatory framework” that “ensures a high level of safety and health protection” and “at the same time promotes innovation” as mentioned in the first recital of the MDR.

Therefore, we have to talk about the future of the regulatory medical device system.

The MDR Amendment published in March (Regulation 2023/607) is supposed to remedy the current bottleneck situation and provide more time for the transfer of products to the MDR as a surgical emergency.

However, there remain open questions and further structural problems in the system with the Notified Bodies, which are not solved by the Amendment Regulation.

By mid-2027 the Commission will evaluate the application of the MDR and produce a report on the progress towards achievement of the objectives. This report will reflect the main elements on the future design of the regulatory system.

Industry and Notified Bodies should work together to find solutions, in particular to improve the conformity assessment procedure (e.g. predictable deadlines, calculable costs, equal access to Notified Bodies or System-inherent possibility of complaints, etc.) and to find solutions for missing regulations for innovations, niche products and so-called “orphan devices”.

11:05
11:35
Coffee Break
11:35
12:15
Navigating the 2nd MDR Amendment
João Martins - Associate Director Regulatory Strategy at Abbott

Regulation EU 2023/607 was published in the Official Journal of the European Union on 20 March 2023. This regulation offered a staggered and conditional extension in the transitional periods of Regulation (EU) 2017/745 (MDR – Medical Devices Regulation) and is also known as the 2nd MDR amendment. In addition, it provided an extension, under certain conditions, to the validity of certificates issued in accordance with Directives 90/385/EEC (AIMDD) and 93/42/EEC (MDD) as well as the removal of the sell-off period.

The extension of the MDR has provided longer transition times for devices, while also ensuring continued access to devices currently certified under the directives and that legacy devices do not have to be recalled from their supply chain (unless they expire). However, it has also posed some challenges on its practical implementation by industry and Notified Bodies.

In this session, you will hear about the reasons behind this extension, the operational and practical implementation of the extension by a manufacturer and the impact it had and still has to industry and global market access.

12:15
12:55
Experience from Industry with MDR Transition Extension
Bassil Akra - Chief Executive Officer at AKRA TEAM GmbH

The various stakeholders in the medical device sector were either positively or negatively surprised by the amendment of the EU MDR. Nevertheless, everyone directly understood its necessity and the importance of this additional time for the continuity of the healthcare system in the EU including other countries relying on CE Mark.

During this session, good and bad experience in the implementation of this amended regulation will be shared and discussed.

12:55
13:55
Networking Lunch
13:55
14:35
Is an EU MDR Article 59 and Article 97 Derogation a Way to Continue to Market?
Nataliya Deych - Vice President Regulatory Affairs EMEA, Latam, Canada at Edwards Lifesciences

Article 59(1) is the originally intended route for derogations and it require that the application is made ‘in the interest of public health or patient safety or health’. Most competent authorities are interpreting this narrowly by requiring that there are no alternatives available on the market and that without the device patient health will be compromised.

When is an Article 97 MDR derogation useful?
An Article 97 derogation might be used to take advantage of the extension to the Medical Device Directive (MDD) certificate transition periods in the newly extended legislation if an agreement for a conformity assessment for the specific device has not been put in place before expiry of the certificate.
How to apply Article 97 of the MDR to devices with expired or expiring certificates? How will it work?

You will know more about MedTech industry experience from my presentation

14:35
15:15
Key Considerations for Device Drug Combination and Impacts of MDCG 2020-12– A NB Perspective
Theresa Jeary - Principal Technical Specialist, Medicinal & Biologics Team at BSI Group, The Netherlands B.V.

The demarcation between medicinal products and devices is becoming ever more important and, with the convergence of emerging novel technologies, the number of drug/device combination products and medical devices incorporating a medicinal substance is increasing.  Such combinations require an appreciation of the differing regulatory expectations between medicinal products and medical devices and brings together very different worlds.

This session shall provide a Notified Body update on MDR requirements and impacts of MDCG 2020-12 and the consultation process and important considerations when developing such combined products.

15:15
15:45
Coffee Break
15:45
16:25
Company Experiences with Device-Drug Combination
Arkan Zwick - Corporate Regulatory Affairs Director at CROMA Pharmaceutical, Austria

Device-drug combinations (DDCPs) are complex products as they require to comply to both drug and device regulations and the conformity assessment procedure involves collaboration of manufacturers, notified bodies and drug competent authorities.

The Medical Devices Regulation (MDR) has a significant impact on the assessment of DDCPs.

First because a justification of the medical device classification based on primary mode of action (PMOA) is to be reconsidered followed by the justification of the drug substance ancillary action.

Second because MDCG guidance requires consultation when moving a DDCP from MDD to MDR.

Third because a clinical evaluation consultation procedure involving European Medicines Agency’s (EMA) expert panels is introduced for class III implants and class IIb active devices administering or removing medicinal products.

The presentation will give an overview on the requirements, steps and challenges governing the compliance of DDCPs with practical insights on how to move legacy DDCPs from MDD to MDR and how to improve interactions between manufacturers, notified bodies and competent authorities to plan and complete conformity assessments in time.

16:25
16:40
Q&A Session
16:40
16:45
Conclusion
Relatori
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.

Sabina Hoekstra-van den Bosch
Info Scientific Board

Sabina Hoekstra-van den Bosch

Regulatory Strategy Principal at TÜV SÜD

Sabina is Regulatory Strategy Principal at Notified Body TÜV SÜD and acts as representative of TÜV SÜD and Notified Bodies at European level. She is Chair of NBCG-Med, the EU Commission’s working group of Notified Bodies, and Vice-President of Team-NB, the EU Notified Bodies’ association.
Sabina has 20 years of experience as pharmaceutical and medical device regulator, serving subsequently in the Medicines Evaluation Board, the Ministry of Health and the governmental organization for clinical investigations in the Netherlands.
She has worked in medtech industry as Lead for European Regulation in Philips, where she acted as leader and expert in European Medical Device and Pharmaceutical Regulations on corporate level and was involved in EU MDR/IVDR implementation.
Sabina has a long track record as volunteer in global professional organizations (DIA and RAPS). She is a regular speaker and faculty member in educational conferences on regulatory topics.
She was co-founder and Chair of the RAPS Netherlands Chapter. She is Fellow of RAPS since 2015 and serves in RAPS Global Board of Directors since 2020.
Sabina holds a PharmD from Leiden University.

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.

Nataliya Deych
Info Speaker

Nataliya Deych

Vice President Regulatory Affairs EMEA, Latam, Canada at Edwards Lifesciences

Qualified to a master’s degree in biotechnology, based in Geneva-Lausanne area in Switzerland and working as a Vice President Regulatory Affairs EMEACLA (Europe, Middle East, Africa, Latin America, and Canada). In my current role I am directing and influencing regulatory strategies and guide the company through multiple regulatory changes and dynamics, including investment into capabilities. I also have a special focus on regulatory and clinical pathways for marketing authorization and patient access, that also includes the risk benefit approach in clinical evidence and Real World Evidence especially for therapies that address unmet medical needs.
Prior to joining Edwards I was a Sr. Director Regulatory Affairs EMEA at Medtronic, headed up Regulatory Affairs at Colgate-Palmolive Europe Sarl. in Basel, Switzerland. I have previously held the management positions in Research and Development, Manufacturing Process Management and Quality Assurance at Unilever company. And have also worked as an independent consultant to the cosmetic industry and for alternative toxicological
methods.

Theresa Jeary
Info Speaker

Theresa Jeary

Principal Technical Specialist, Medicinal & Biologics Team at BSI Group, The Netherlands B.V.

Theresa Jeary holds a master’s degree in Pharmaceutical Science from the Royal College of Surgeons, Ireland and is eligible to be a Pharmaceutical Qualified Person.

Theresa has over 30 years’ experience working in both the Pharmaceutical and Medical Device industries and has worked in a variety of roles across the full development cycle from product concept and early stage development, process transfer, validation and regulatory departments.

In addition to her product development and global regulatory expertise, Theresa has over 12 years Notified Body experience, first at BSI as a technical expert for devices with ancillary medicinal substance and borderline classifications moving then to LRQA where she held the role of Head of Notified Body for several years.

More recently Theresa has worked as a consultant to the Medtech sector assisting Manufacturers in their product development and supporting them in navigating their legal requirements and changes to the Medical Device Regulations.  Theresa re-joined BSI in August 2020, and is a principal technical specialist in the Medicinal and Biologics Team.

Theresa is a regular presenter on combination products in the EU and is the chair of the Team-NB Working Group for Rule 21 Devices, she regularly contributes to various scientific publications and regulatory guidance and has extensive experience of interacting with EU Competent Authorities.

João Martins
Info Speaker

João Martins

Associate Director Regulatory Strategy at Abbott

João is a Doctor of Pharmacy (PharmD) and Associate Director of Regulatory Strategy at the Abbott Quality and Regulatory group.
In his role, he supports Abbott businesses with regulatory intelligence, strategic direction and technical guidance in the implementation of new regulatory regimes or in regulatory transformation programs, such as implementation of the EU MDR/IVDR, Eurasian regime, UK and Switzerland’s new regulatory frameworks.
João participates to various MedTech Europe’s Working Groups (WGs) and currently serves as the chair of the Economic Operators WG at MTE.
Prior to joining Abbott, João worked for other medical device manufacturers as well as a MedTech regulatory consultant.

Rob Nelissen
Info Speaker

Rob Nelissen

Professor and Chairman department Orthopaedics, Rehabilitation, Physiotherapy at Leiden University Medical Center (LUMC)

Rob Nelissen is professor and chairman department Orthopaedics, Rehabilitation, Physiotherapy at Leiden University Medical Center (LUMC). Title doctorate thesis (1995): ‘Fundamental aspects of the clinical evaluation of total joint prosthesis’. After his orthopaedic training (Leiden), he finished a Total Joint Fellowship in the USA (1993). 2005 Professor Experimental Orthopaedics. 2006 Chairman and professor Orthopaedics LUMC. 2016 Medical Delta Professor at Delft University of Technology. He was (vice)president of the Netherlands Orthopaedic Association (NOV) (2014 – 2018). He is the co-founder (2007), former chairman of the Dutch Arthroplasty Register (LROI) which is the third largest implant registry worldwide (> 1 million implants, completeness 99%). The LROI is a quality and traceability Register of implant surgery and patient outcome. Currently he is chairing the registration council of LROI. He is Secretary General of EFORT, co-chairman / co-founder of N.O.R.E. (Network Orthopaedic Registries of Europe).
Since 2019 he is observer CIE workgroup of MDCG (Medical Device Coordination Group) DG SANTE European Commission. Chairman Expert Panel Orthopaedics Trauma Rehabilitation Rheumatology under the MDR (EU commission, EMA).
His research relates to “optimising clinical outcome” and “prediction modelling of outcome”. The latter relates both to fundamental research as well as healthcare evaluation research. He published about 500 peer-reviewed articles, with focus on healthcare evaluation and prognostic modelling and optimizing outcome in arthroplasty patients. He successfully supervised over 60 PhD students.

Christina Ziegenberg
Info Speaker

Christina Ziegenberg

Deputy Managing Director, Head of Regulatory Affairs at BVMed, Berlin

As a natural scientist in the field of chemistry and pharmacy and a doctorate in scientific medicine, Christina began her career as a chemical development engineer in the building and construction industry within the field of explosives. Subsequently she took over market surveillance and enforcement tasks in the areas of medical devices, IVDs and radiation protection as head of Medical Devices in the Office of Public Health of Liechtenstein which is the Competent Authority for medical devices and IVDs in Liechtenstein. In April 2019 she continued her career at BVMed, the German Medical Technology Association, where she took over responsibility for regulatory affairs with a focus on medical devices but also environmental and sustainability.

Workshop
25 September 2023
PRE-CONFERENCE WORKSHOP

From 13:30 to 17:30 | NH Vienna Airport, Vienna

From Good to Excellent: The Summary of Safety and Clinical Performance (SSCP)
An advanced training to improve your SSCP and write it in the most efficient way


Introduction
The Summary of Safety and Clinical Performance (SSCP) is a document that is with a unique structure and format: it is intended to include detailed information on a medical device for both healthcare providers and patients and will be available for the public. Many manufacturers already know how to write an SSCP.

We also have read MDCG 2019-9, but how can we go from good to excellence? And how can we improve a document which will be public soon?
To be able to work on your SSCP you need strong technical skills. You also have to be able to translate the technical documentation into lay language: Are we complying with a regulatory requirement or are we really communicating with the public?
Consistency with the Technical Documentation, different expectations from the manufacturer and the Notified Body and strict timelines are additional hurdles.

This workshop will navigate you through the needed skills to achieve excellence and positively impact the final document.

Programme

  • Introduction to Article 32 of EU MDR 2017/745 (Summary of Safety and Clinical Performance)
  • Structure and Content: The MDCG (Medical Devices Coordination Group) Guidance 2019/9
  • How to optimize input documents for more efficient SSCP writing
  • Best practice tips to summarize safety and performance data
  • How to improve the patients’ section of the SSCP

Who should attend?
The workshop is addressed to Clinical Affairs, Quality Assurance, Product Managers and Medical Writers.

Participant experience

This workshop is intended for personnel with little experience in regulatory writing, including the Summary of Safety and Clinical Performance, under the Medical Devices Regulation 2017/745 (EU MDR) and with little experience in the preparation of lay summaries.

Teaching methods
The workshop will be a mixture of presentations, team discussion, brainstorming and practical examples.

Lecturer

Dr. Katharina Friedrich, MD – Freelance Medical Writing Consultant
Katharina Friedrich is a medical writer with 5 years of experience in MDR regulatory writing. She is based in Heidelberg, Germany and works as a Freelance Medical Writing Consultant for various medical device companies, including startups and global players. She prepares Clinical Evaluation Plans and Reports, PMCF Plans and Reports and SSCPs in compliance with MDR 2017/745 for class I to class III devices. She also supports development projects and the conduction of PMCF activities. As medical doctor she has experience in the field of orthopedic, spine and trauma surgery and intensive care medicine.

At the end of the training, you will be able to:

  • Understand the regulatory requirements for the SSCP
  • Optimize the relevant input documents for the SSCP and learn how to extract the most relevant information
  • Prepare lay summaries, including product description and summary of study results
  • Prepare a summary of safety and performance information for healthcare professionals
  • Understand common pitfalls with the preparation of the SSCP and know how to avoid them
Exhibitors

Platinum Sponsor

 

Silver Sponsor

 

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

Contatti

Laura C Collada Ali
MedDev Day Scientific Coordinator
medicalwriting@lsacademy.com

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


Quote di iscrizione

Pre-Conference Workshop + Conference:

€ 1.045,00* SUPER Early Bird fee until 01 July 2023
€ 1.105,00
* Early Bird fee until 09 September 2023
€ 1.310,00* Ordinary fee
€ 660,00* Freelance, Academy, Public Administration

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

Pre-Conference Workshop:

€ 560,00
* Early Bird fee until 09 September 2023
€ 670,00* Ordinary fee
€ 310,00* Freelance, Academy, Public Administration

Fee includes: seat at the training, training material, coffee break, organisational office assistance, certificate of attendance.

Conference:

€ 670,00* Early Bird fee until 09 September 2023
€ 790,00* Ordinary fee
€ 430,00* Freelance, Academy, Public Administration

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

* for Italian companies: +22% VAT


Informazioni utili

The conference will take place at:

NH Vienna Airport
Einfahrtsstrasse 1- 3, 1300 Vienna

The NH Vienna Airport Conference Center hotel enjoys a convenient location just across from the arrivals hall at Vienna Airport. That means we have unbeatable transport links – if you want to head into the city, it’s just a 16-minute train ride to central Vienna.

  • From Vienna International Airport (VIE): it is a 6 min walk to get to the hotel
  • Closest metro station: Flughafen Wien (City Airport Train)
  • To get to the city center of Vienna, you can use the City Airport Train, which departs every 30 minutes. The trip will take 16 minutes. Click here for the timetable.

COVID-19
LS Academy is aware of the evolving impact of COVID-19 and is committed to offering safe and secure face-to-face courses and conferences. From physical distancing, protect, detect, cleaning and hygiene.  LS Academy ensures that all our events are conducted in accordance with official government guidelines and regulations, understanding that these measures may vary and change as the situation evolves.

Edizioni Passate
2022
MDR 2017/745 Reality Check – Readiness of the EU System
2021
MedDev Day 2021
2020
MedDev Day 2020
2019
MedDev Day 2019
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<p style="text-align: center;"><strong>NH Vienna Airport<br />
</strong>Einfahrtsstrasse 1- 3<br />
1300 Vienna &#8211; Austria</p>

NH Vienna Airport
Einfahrtsstrasse 1- 3
1300 Vienna – Austria

<p style="text-align: center;"><strong>NH Vienna Airport<br />
</strong>Einfahrtsstrasse 1- 3<br />
1300 Vienna &#8211; Austria</p>
<p style="text-align: center;"><strong>NH Vienna Airport<br />
</strong>Einfahrtsstrasse 1- 3<br />
1300 Vienna &#8211; Austria</p>
<p style="text-align: center;"><strong>NH Vienna Airport<br />
</strong>Einfahrtsstrasse 1- 3<br />
1300 Vienna &#8211; Austria</p>