About

The EU MDR 2017/745 was published in May 2017 with a transition period of three years which was extended by one additional year to address COVID 19 restrictions and limitations.
This additional year was taken away from the predefined grace period in Article 120 of the EU MDR 2017/45. During the grace period, which will end in May 2024, manufacturers are still allowed to place devices certified under the Medical Device Directives to the Union Market.

With approximately 2 years to go till the end of the grace period, manufacturers and notified bodies are under growing time pressure to move devices from the old Directives to the EU MDR 2017/745.
This move is leading to a lot of issues which are connected to capacity limitations, continuous new interpretations, and administrative burdens.

After more than 4.5 years after publication of the regulation just 50% (n=27) of the notified bodies who applied (n=54) to be designated and notified for the new regulation were successful and are enabled now to perform their task under the new legislative framework.
Nevertheless, just 10% of these notified bodies hold a full scope of designation.

More than 90 guidance documents were published since the publication of the regulation to explain the meaning of the legal text, leading to new interpretation in a continuous manner and impacting already running conformity assessment processes critically. Common specifications which are essential for the system are still under preparation. Voluntary consultation process to address the missing pre-assessment elements and technical meeting services of notified bodies is not available.

During this annual Medical Device conference, keynote speakers from the various sectors will share their views, current experiences, and recommendations towards a smoother implementation of the EU MDR 2017/745.

Enrol in this face-to-face Medical Device conference to take place in Barcelona on 27th September 2022!

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 - Medical Writing & 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.

Programme
27 September 2022
09:00
09:30
Registration
09:30
09:40
Welcome from the Scientific Board
09:40
10:10
Impact of the EU Regulations on the daily work of Competent Authorities
Thomas W. Møller - Former Director for Medical Devices at Danish Medicines Agency and former chair of the CAMD

With new regulations on IVDR and MDR, the regulatory system for medical devices has moved to a new level. The challenges differ for the industry, notified bodies, and competent authorities.

From a competent authority point of view Thomas’ presentation will address:

  • The challenges seen from Competent Authorities in Europe
  • Joint initiatives to improve the new regulatory system
  • Market adjustment as a consequence of the new regulation
  • Recent developments in Europe and future challenges
10:10
10:40
European MDR update – Status of implementation
Dario Pirovano - Senior Regulatory Adviser at MedTech Europe

Under the European Commission website, a descriptive text under the Medical Devices Regulations reads as follows: “The new Regulations will create a robust, transparent, and sustainable regulatory framework, recognised internationally, that improves clinical safety and creates fair market access for manufacturers and healthcare professionals.”

Thus said, what is the status of implementation of these new regulations? Have any of these future visions already been achieved?

In this session, we will presenting last-minute updates from the MedTechEurope.

10:40
11:20
Capacity of Notified Bodies
Sabina Hoekstra-van den Bosch - Regulatory Strategy Principal at TÜV SÜD

This presentation will focus on the notified capacity, will analyse the root causes and discuss the current state of play.

The relevant action points in the MDCG Position Paper 2022-14 “Transition to the MDR and IVDR
Notified body capacity and availability of medical devices and IVDs”, which was published in August 2022, will be discussed as well.

11:20
11:50
Coffee break
11:50
12:30
First Experience with EU MDR Certification – are we there yet?
Elizabeth Gfoeller - Corporate Director, Regulatory Affairs at MED-EL Elektromedizinische Geraete GmbH

MED-EL is an Austrian manufacturer o class III, high risk devices. As a high risk medical medical device manufacturer based in the EU, we purposely determined an early adoption strategy to MDR, submitting our first MDR files and undergoing our initial MDR QMS audit in 2019. Consequently, we were among the very first to receive MDR certification in March 2020 for our Class III implantable systems and associated lower risk devices. Does this mean that we are done?

In this presentation I would like to share our learnings and challenges as we continue to transit the unpredictable and ever surprising MDR grace(less) period.

12:30
13:10
Lessons Learned with MDR Consultation Requirements
Bassil Akra - Chief Executive Officer at AKRA TEAM GmbH
Arkan Zwick - Corporate Regulatory Affairs Director at CROMA Pharmaceutical, Austria

The EU MDR 2017/745 introduces new or updated consultation requirements during special conformity assessment processes. These consultations are adding complexity to the introduction of the regulation and require the involvement of designated authorities or EMA or the newly established EU expert panel to support the final certification decision of notified bodies.

During this session we will present examples of these critical consultation processes and share the initial learnings with regards to clinical evaluation consultation procedure, voluntary expert panel consultation and communications with medicinal agencies for the re-consultation of device drug combination products.

13:10
14:10
Networking lunch
14:10
14:50
Compliance in the Grace Period – Balancing MDD vs. MDR
Philippe Auclair - Senior Director, Regulatory Strategy and Advocacy at Abbott Quality and Regulatory

The presentation will review a manufacturer’s experience on navigating the transfer from MDD to MDR.

It focusses on requirements for legacy devices during the extended transition and the process of remediation of MDD to MDR.

Practical considerations and lesson learned will be given, as as implications for portfolio management.

14:50
15:30
How to ensure better Readiness of your Application?
Gert Bos - CSO at Qserve Group

With the gradual implementation of the EU MDR into reality, we slowly start seeing clarity in the actual expectations the notified bodies have towards the content of the medical device technical documentation. Some of the guidance is general, some is coming in second wave via harmonization between notified bodies, and some are notified bodies specific.

This presentation will help you maneuver these elements and clarify how you best prepare and ensure sufficient readiness for your documentation to withstand the scrutiny of the new notified bodies eyes.

How to go from gap assessment to reality; how to deal with the back and forth between various documents that need to be updated, but influence each other on claims, risks, clinical benefit etc. Strategies to include mock audits and mock dossier reviews.

The session will include some best practices as well as discussions with the audience to get all helpful insights shared between participants.

15:30
16:00
Coffee break
16:00
16:30
Round Table: What? When and How?

Moderated by Bassil Akra, Chief Executive Officer at AKRA TEAM GmbH

The perfect opportunity to discuss key issues with key industry experts.

16:30
16:40
Conclusions
All day long
Meet-the-Experts one-on-one slots: MDR State of the Art & Medical Writing

Are you seeking assistance from a Medical Writer expert to address your questions and concerns about the State-of-the-Art of your device?

Secure a half-an-hour meeting with one of our Medical Writers by sending a request through ilaria.butta@lsacademy.com Katharina Friedrich and Laura C Collada Ali will be delighted to address your questions or concerns.

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.
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 Pharmaceutical, Austria. CROMA is a private global pharmaceutical and surgical company with products in ophthalmology, orthopedic and aesthetic dermatology. With more than eleven 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.
Philippe Auclair
Info Speaker

Philippe Auclair

Senior Director, Regulatory Strategy and Advocacy at Abbott Quality and Regulatory
Philippe joined Abbott in 1994. He represents European Industry in various European Commission expert groups and actively participates as trainer in programs organized by Regulatory Authorities around the world. Since 2015 he is an Industry advisor to the Asian Harmonization Working Party Technical Committee. He is Chairman or co-chair of the Post Market Surveillance, the Notified Body, the International Regulatory and the clinical Working Groups of the European medical device manufacturers’ trade association Medtech Europe. He is a member of the European Advisory Committee and of the board nominating committee of the Regulatory Affairs Professional Society (RAPS). Philippe received the “Global Leadership Award” from RAPS in 2010, has been elected “RAPS Fellow” in 2012. Philippe is also the proud recipient of an FDA CDRH Director’s “Special Citation” for his work at Global Harmonization Task Force.
Gert Bos
Info Speaker

Gert Bos

CSO at Qserve Group
Gert is an expert in European regulations based on more than 25 years hands-on working in the field, as auditor, product reviewer, regulatory specialist, Head of notified body and strategic, regulatory and business consultant. He has been leading the Notified Bodies in Brussels for many years, and has strongly supported the regulatory debate with the EU Commission, EU Parliament and the EU Council of Ministers. He combines strong experience in quality, compliance and regulations with a pragmatic, result driven approach at both operational and strategic level. From his PhD in Biomaterial Sciences, and PostDocs in controlled release of drugs and gene therapy, he has dealt as technical reviewer and consultant with a large range of devices mostly in the non-active device area. For his contributions to the regulatory profession he has been awarded as Fellow of RAPS. Gert is president of RAPS, and serves as board member of RAPS Europe.
Elizabeth Gfoeller
Info Speaker

Elizabeth Gfoeller

Corporate Director, Regulatory Affairs at MED-EL Elektromedizinische Geraete GmbH
Joining MED-EL in 2006, Elizabeth Gfoeller currently leads the Corporate Regulatory Affairs function responsible 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. She acts as the responsible person for communication with regulatory agencies and engages in lobbying activities. Previously Elizabeth worked in the mobile telecommunications sector in regulatory compliance and data protection in Vodafone Ireland. Her educational background is in social sciences, with her graduate and post graduate studies in Sociology completed at the University of the Witwatersrand, South Africa where she was active for many years both as a university lecturer and social researcher in the non-government sector researching into diverse issues such as gender violence, adult literacy, trade unions and demilitarisation.
Thomas W. Møller
Info Speaker

Thomas W. Møller

Former Director for Medical Devices at Danish Medicines Agency and former chair of the CAMD
Thomas is an experienced manager who has worked with strategy, efficiency and management projects in health care, environmental and engineering. As former director of medical devices in the Danish Medicines Agency, Thomas has worked with the Danish health care sector, MedTech industry and Patient organizations to secure patient safety. Thomas holds a master’s degree in political science from the University of Copenhagen. In addition, he has undertaken several courses and continuing education in project management and leadership and has several years of practical management experience in the public sector. Thomas has recently moved to a position in the global pharma industry.
Dario Pirovano
Info Speaker

Dario Pirovano

Senior Regulatory Adviser at MedTech Europe
Dario Pirovano, after having worked in Italy in the R&D for a medical device company, joined the European Commission as technical expert for 4 years, where he contributed to the drafting and negotiating of the 90/385 /EEC and 93/42/EEC directives. Dario has over 30 years’ experience in medical technology as designer and regulatory affairs expert. In 1995 he founded Pirovano Management SPRL, a consulting firm advising manufacturers, Notified Bodies and authorities in regulatory matters relating to medical technology. Since 2002 he act as a consultant as Senior Regulatory Adviser for MedTech Europe Dario can be considered the historical memory of the development of medical devices regulation in Europe. He holds a Doctorate in Engineering from the Politecnico di Milano.
Training
The pre-conference training is SOLD OUT!

We’re planning a new edition. Contact us for more info ilaria.butta@lsacademy.com

26 September 2022
PRE-CONFERENCE TRAINING

From 14:00 to 18:00 | H10 Marina Barcelona, Barcelona

Periodic Safety Update Report (PSUR)
Are you ready to satisfy the regulator’s expectations?

 

Introduction
The Periodic Safety Update Report (PSUR) is an entirely new type of report that has been introduced in Article 86 of the Medical Device Regulation (MDR). It requires manufacturer of class IIa, class IIb and class III devices to prepare a Periodic Safety Update Report (PSUR) for each device and where relevant for each category or group of devices summarizing the results and conclusions of the analyses of the PMS data gathered.

The regulatory requirement is set, yet the PSUR is a new document and manufacturers often do not have a clear view of what it entails:

  • What do MDCG guidelines say?
  • What are the expected data sources that need to be analysed and presented?
  • Which type of preventive and corrective actions need to be listed in the PSUR?
  • What are the main findings that should come out of the PSUR?
  • Where does it fit within the PMS context and other post-market documents such as the PMCF Evaluation Report, the CER and the SSCP?

This workshop will provide relevant information to draft a PSUR, including what data should be presented and how it should be reported. It will offer the experience of an industry-expert for all representatives involved in working with medical devices under the MDR umbrella.

Programme

  • The regulation, the guidelines and their context
  • Submission obligations and timelines
  • Data to be presented and how it should be presented
  • Reportable data and main findings
  • Challenges and lessons learned from first experiences

Who should attend?
The course is addressed to:

• Clinical Affairs
• Post-Market Surveillance
• Regulatory Affairs
• Medical Writers
• Product Managers
• CROs

Teaching methods
Interactive training

Lecturer
Markus PöttkerPMS EU MDR Workstream Lead at Smith&Nephew

Markus is a member of the EU MDR Project team at Smith&Nephew leading the Post Market Surveillance work stream. In this role, he is responsible that the requirements of the EU MDR are correctly interpreted and implemented across the company. Prior to this, he spent seven years in Quality & Regulatory roles, at last he was the Director of Complaint Management and Head of Regulatory Compliance with global responsibility for Complaint Handling, Medical Device Reporting and interaction with Regulatory Agencies. Markus is co-chair of MedTech Europe’s PMS & Vigilance Working Group and a member of the MDCG Task Forces for Vigilance, PSUR and PMS. Markus holds a master’s degree in law from WWU Münster, Germany.

Markus is a bridge builder between the regulatory requirements for medical devices and practical implementation in companies. In addition to complex regulatory issues, he is passionate about digitalisation and lean process optimization – but also about human communication. He believes that technical innovation will continue to transform the medical technology industry.

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

  • Understand the regulatory requirements for PSUR
  • Identify the relevant input documents for your PSUR
  • Prepare PSURs for different device classifications
  • Understand challenges and lessons learned from first experiences of PSUR preparations
Exhibitors

Platinum Sponsor


MDR State of the Art & Medical Writing: Meet-the-Experts one-on-one slots!
Are you seeking assistance from a Medical Writer expert to address the State-of-the-Art of your device?


Secure a half-an-hour meeting with one of our Medical Writers by sending an email to ilaria.butta@lsacademy.com Katharina Friedrich and Laura C Collada Ali will be delighted to address your questions or concerns.

Meet-the-Experts is an informal meeting event in which medical writer experts share experiences regarding SOA writing, databases to be used, and advice on how to build a strong strategy within this document.
The initiative provides attendants to the MedDevDay with direct access to experts in the field.

Contacts

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

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


Registration Fee

Pre-Conference Training + Conference:

€ 1.045,00* SUPER Early Bird fee until 01 July 2022
€ 1.105,00
* Early Bird fee until 09 September 2022
€ 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 Training – SOLD OUT
€ 560,00
* Early Bird fee until 09 September 2022
€ 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 2022
€ 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


Useful Information

The conference will take place at:

H10 Marina Barcelona
Av. Bogatell, 64-68 – E08005 – Barcelona

H10 Marina Barcelona is 10 minutes walk from the beach and 5 minutes away you have the Olympic Village. Closer to the Metro stop, Bogatell: it is just 2 minutes behind the hotel and can take you into the city centre in 15 minutes, or you could even walk in about 30-40 minutes.

100 m from Bogatell metro station (Line 4)
300 m from Marina metro station (Line 1)
15 km from Barcelona-El Prat airport


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.

Past Conferences
2021
MedDev Day 2021
2020
MedDev Day 2020
2019
MedDev Day 2019
Book Now

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<p style="text-align: center;"><strong>H10 Marina Barcelona<br />
</strong>Av. Bogatell, 64-68<br />
E-08005 &#8211; Barcelona</p>

H10 Marina Barcelona
Av. Bogatell, 64-68
E-08005 – Barcelona

<p style="text-align: center;"><strong>H10 Marina Barcelona<br />
</strong>Av. Bogatell, 64-68<br />
E-08005 &#8211; Barcelona</p>
<p style="text-align: center;"><strong>H10 Marina Barcelona<br />
</strong>Av. Bogatell, 64-68<br />
E-08005 &#8211; Barcelona</p>
<p style="text-align: center;"><strong>H10 Marina Barcelona<br />
</strong>Av. Bogatell, 64-68<br />
E-08005 &#8211; Barcelona</p>