Medical Device Regulations & Compliance Summit 2022 - uventia

Medical Device Regulations & Compliance Summit 2022

Medical Device Regulations & Compliance
Event Details


The initial three-year transition period for the EU Medical Device Regulation 2017/715 (MDR) was expected to end in May 2020. Once the COVID outbreak occurred, the European Commission proposed to extend the implementation date by one year. The IVDs parallel regulations will apply from May 2022. However, it is important to note that this delay should not be considered as a grace period. Ultimately, the regulations have been updated to ensure that the health and safety of patients is a top priority.

Our virtual meeting proposes the actions medical device manufacturers could take to strengthen the implementation strategy for EU MDR and IVDR. The expert speakers will share all the different ways to prepare your company and team for a smooth transition; update your QMS for EU MDR; meet Notified Body expectations during the audit; comply with requirements for vigilance reporting and post-market surveillance; review labeling and packaging challenges under updated UDI; evaluate strategies to remediate gaps in clinical data and more.

Learn valuable insights and get answers on how to improve the efficiency of the implementation process in terms of time, cost and stuff. We look forward to e-meeting you at the event!


  • EU MDR implementation lessons learned: notified bodies perspective.
  • Challenges to implement the MDR.
  • How to approach risk management under MDR.
  • Performing post market clinical follow-up (PMCF) activities.
  • Clinical evaluation for a medical device under MDR.
  • How to meet post market surveillance requirements.
  • Risk management in support of EU MDR compliance.
  • Fundamental challenges to IVDR technical documentation.
  • Eudamed, the latest and experiences so far.
  • Extractables & leachables studies as important part of biocompatibility assessments.
  • Journey and lessons learnt by the first company to achieve a certification of their QMS system and product against the EU MDR.
  • Biocompatibility of medical device/medical device combination products.
  • Biological safety evaluation over product life cycle.


CxO, VP, Directors, Heads, Managers of

  • Medical Devices/In Vitro Diagnostics/ Combination Products
  • Regulatory Affairs/ CMC/ Compliance
  • Device Development/ Device Engineering
  • Design Controls/Device Design
  • Risk Management/ Safety Risk
  • Traceability/ Sterilization
  • Research & Development
  • QA/ QC
  • Post Market Surveillance/ Vigilance

[Agenda] Medical Device Regulations & Compliance Summit 2022

Download the full summit program to find speaker biographies, case studies, key takeaways, the day's schedule, and details of each session.

Speaking Companies

● 3M Company ● Abbott Laboratories ● aidoc medical ltd. ● AKRA TEAM GmbH ● Alsalama Health Care ● AMO Germany GmbH ● B.Braun ● B.Braun Adria RSRB d.o.o. ● B.Braun Medical ● BD ● Berlin Heart GmbH ● Biophoenix Ltd ● Boston Scientific Corporation ● Cardinal Health ● Carl Zeiss Meditec ● Critical Healthcare Limited ● EirMed Ltd ● Greiner Bio-One North America, Inc. ● GSK ● Humedics GmbH ● Institut Straumann AG ● Integra LifeSciences ● Intertek (Schweiz) AG ● Johnson & Johnson ● Lonza ● Medtronic ● Merck Sharp & Dohme ● Nanobiotix SA ● National Standards Authority of Ireland ● Nikon Corporation ● Novartis Pharma AG ● Novocure GmbH ● Omicron-Laserage Laserprodukte GmbH ● Optos Plc ● POLYTECH Health & Aesthetics ● Prestige Consumer Healthcare ● Quality Health Innovations Ltd ● Regulatory House s.r.o. ● Roche Diagnostics ● Salts Healthcare ● Sandoz ● Sanofi-Aventis ● Siemens Healthcare GmbH ● Synergia Medical ● Teoxane SA ● TÜV Rheinland AG ● UCB ● UCB Biopharma SRL ● Veeva MedTech

Speaker Board
Kemine Hale
Associate Director, Global Regulatory Affairs
Novocure GmbH
Gero Viola
Coordinator Regulatory Affairs
TÜV Rheinland AG
Laure-Anne Thieren
Sr Quality Manager
Johnson & Johnson
Pedro Mendes
Global Technical Steward Devices
Novartis AG
Sean OCallaghan
Certification and Inspection Officer
Carine Cochereau
Vice President Regulatory Affairs International
Integra LifeSciences
Bijan Elahi
Technical Fellow and Corporate Advisor
Xiaoling (Sharlene) Dai
Sr. Principal Toxicologist
Abbott Laboratories
Mike Wallenstein
Global Head MDR Implementation, External Engagement & Compliance
Novartis Pharma AG
Christine Lynn Lanning
Distinguished Scientist
Merck Sharp & Dohme (MSD)
Richard Houlihan
EirMed Ltd
Shaloo Sood
Product Development Engineer
Institut Straumann AG
Bassil Akra
Tino Otte
Head of Sales and Consulting
Intertek (Schweiz) AG

Summit Agenda

◆  State of the play.

◆  Analysis of projects: from show stoppers to best practice.

◆  Perspective.

TÜV Rheinland AG, DE

◆  MDR with medicinal products.

◆  MDR for Ex-EU countries.

◆  Working with 3rd parties.

◆  Upcoming regulations.

Novartis, ES

◆  Establishing a risk management plan for each device.

◆  Risk assessment in new product design and development.

◆  Evaluation of risks associated with the intended use and misuse of the device.

◆  Implementing effective risk mitigation strategies.

◆  Connecting risk management with clinical evaluation and PMS.

Institut Straumann AG, CH

◆  Requirements of the EU MDR on PMCF.

◆  Process leading to a justified PMCF activity.

◆  General versus Specific PMCF.

◆  Expectations of Notified Bodies.

◆  Common pitfalls and tips on how to prepare a compliant PMCF Plan.


◆  Key principles on Clinical Evaluation Robustness and New attention under MDR.

◆  Review of the latest MDCG guidances and status of upcoming guidance’s.

◆  Links with Clinical Investigation Strategy and ISO 14155 exigencies.

◆  Equivalency.

◆  Learning from the first CECP assessments.

Integra LifeSciences, BE

◆  Moving to proactive and compliant PMS system.

◆  Trend reporting, vigilance.

◆  Conducting a compliant Periodic Safety Update Report (PSUR).

Johnson & Johnson, BE

◆  Risk reduction strategies.

◆  Reporting requirements.

◆  Post-Market risk management.

Medtronic, USA

◆  Understanding the implications of the Inteneded Purpose Statement.

◆  Performance Evaluation – more than 3 Pillars.

◆  Know your (technical file) audience.


◆  What is the latest from the European Commission on EUDAMED.

◆  Our experiences on 1000’s of device uploads todate.

◆  Tips to avoid your uploads being rejected.

EirMed Ltd, BG

◆  Patient safety requires precise knowledge about extractables and leachables released by medical devices.

◆  Proper chemical characterization is a mandatory step of biocompatibility studies.

◆  ISO 10993-18 delivers the right framework for the study design.

◆  High complexity of many medical devices increases risk of leaching.

◆  Depending on device class, application scenario and contact time E&L study design needs to be aligned.

◆  Several analytical screening techniques should be utilized to cover all compound classes from volatile to non-volatile.

◆  Harsh extraction conditions might be required depending on the application scenario which could cause unexpected problems.

◆  We will provide examples for reasonable analytical screening strategies.

◆  Typical problems and limitations during analysis will be discussed.

◆  Case studies with will be presented to explain possible solutions in detail.

Intertek (Schweiz) AG, CH

◆  Strategy used to adapt a quality system to the MDR.

◆  Gap assessing your quality system and implementing a plan to adapt and upgrade to continuously improve and meet the MDR and other Global HA requirements.

◆  What does ready look like? Key lessons learned on the transition.

◆  Discuss the product strategy employed and the challenges faced in adapting a legacy platform product to the MDR, which also required an up classification.

◆  Outcomes, challenges and strategies for transition and implementation.

Novartis Pharma AG, CH

◆  Biocompatiblity as part of the QMS.

◆  Developing Biocompatibility Strategies.

◆  Performing Risk Assessments for Biocompatibility.

◆  Common Mistakes to Avoid.

Merck Sharp & Dohme (MSD), USA

◆  Navigating regulatory challenges to develop biological safety evaluation strategy.

◆  Development, produce products, and sourcing - team approach in biological safety risk assessment.

◆  Utilization of toxicological risk assessment in biological safety evaluation.

◆  Lessons learned in biocompatibility documentation.

Abbott Laboratories, USA

Event Details