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 |
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09:00
09:30 |
Registration
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09:30
09:40 |
Welcome from the Scientific Board
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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:
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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.” In this session, we will presenting last-minute updates from the MedTechEurope. |
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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 |
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11:20
11:50 |
Coffee break
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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. |
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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
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. |
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13:10
14:10 |
Networking lunch
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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. |
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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. |
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15:30
16:00 |
Coffee break
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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. |
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16:30
16:40 |
Conclusions
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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

Sabina Hoekstra-van den Bosch

Arkan Zwick

Philippe Auclair

Gert Bos

Elizabeth Gfoeller

Thomas W. Møller

Dario Pirovano
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 Pöttker – PMS 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.