Clinical evaluation is conducted as an ongoing process throughout the life cycle of a medical device, and the Clinical Evaluation Report (CER) is required for the conformity assessment process leading to CE-Marking. Pertinent clinical data from equivalent devices obtained from literature can be used as proof of clinical evidence on safety and efficacy, making the process of regulatory approval quicker and more cost effective.

This session will discuss:

• Literature requirements of medical device regulations (MDR 2017/745) and guidelines (MEDEDEV 2.7/1 rev.4)
• Best practices for formulating a systematic literature search
• A workflow for building search strategies and finding the best available evidence using the Medical Device specific framework and indexing in Embase

Speakers:

Danielle Thomas
Customer Consultant
Elsevier Life Sciences 

Michelle Mohsenin
Product Manager
Elsevier Life Sciences Solutions 

The session is aimed at reporting the last experiences of the certification process under MDR from a Notified Body perspective. The most frequent non-conformities regarding the evaluation of the technical documentation will be disclosed and discussed as well as the formal hurdles which usually make the certification process longer. An update will be given also in relation to the bottle neck of 2024 and possible measures to be taken by all the stakeholders to minimize the risk of products loss.

Speaker:

Daniele Bollati
Product Conformity Assessment
IMQ

Regulatory Affairs is poised to play a critical role in supporting the current MDR and IVDR required clinical / performance evaluation process, from project implementation through report writing and finally, the on-time submission to the notified body. From the early planning stage through completion of all required written deliverables, this presentation examines some of key drivers of project success, such as early assessment of data sufficiency, equivalence considerations, internal readiness of critical documentation, project planning strategies and how to identify potential roadblocks and proactively find solutions to common problems.

Learning Objectives:

1. Identify critical components of the clinical evaluation process that influence project success.
2. Describe how Regulatory Affairs can support cross-functional stakeholders and lead critical decision-making throughout the clinical evaluation process.
3. Recognize and implement early mitigation strategies to overcome roadblocks and drive to on-time submission.

Speaker:

Laurie Mitchell
President
Criterion Edge

With the MDR 2017/745 there is greater emphasis on clinical data and clinical evaluations, next to post-market surveillance, post-market performance and the health and safety of patients. For the re-certification of devices already on the market and initially CE-marked under the MDD and AIMDD, especially through the route of equivalence, the manufacturer has to prove availablility of sufficient clinical data for safety and performance. Thus, post-market clinical follow-up studies, registers and Real World Evidence (RWE) are moving further into the focus of data collection routes to support re-certification.

In this webcast session participants will get an overview on the Clinical Investigations Art. 62 through 82 MDR 2017/745, in connection with Annex I - Clinical Development Stages of the ISO 14155:2020. Differences and specifics of PMCF Clinical Investigation per Art. 74.1 MDR 2017/745 and Other Studies per Art. 82 MDR 2017/745 will be highlighted for guidance, which applies to the different post-market data collections activities. Considerations for data protection per GDPR 2016/679 will also be discussed within the session.

Speakers:

Andrea Offer
Senior Principal Project Manager
ECLEVAR Medtech GmbH  

A rigorous and strategic systematic literature review (SLR) to support ongoing post-market literature surveillance activities within one’s organization is not an option anymore. In this session the speaker shall illustrate how she and her team approached SLR within Medtronic and how they leveraged the award-winning process to support Post-Market Surveillance activities. The session would cover,

• Need of SLR
• Challenges & Opportunities
• Simplifying SLR
• Defining and Executing Proactiveness
• Wins

Speakers:

Queenita Fernandes
Senior Medical Safety Manager, Medical Surgical
Medtronic  

This lively panel discussion will provide actionable insights, practical takeaways, and key learnings on IVDR including:

• Global regulatory overview and summary
• Highlights of the latest requirements and guidelines
• Reflections and learnings from real-life challenges
• Best practices in managing risk based on regulatory requirements

Speaker:

Amy Chen
Market Access & Regulatory Consultant
Compliance & Risks 

Matt Kuo
Chief Product Officer
Compliance & Risks 

• Introductions
• Overview and comparison of IVDD and IVDR
• Date of Application, transition periods and what that looks like for your company
• Implications of EUDAMED delay
• Class D devices
• Key things to note

Speaker:

Molly Rogers
Inspection & Certification Officer
National Standards Authority of Ireland (NSAI)