The annual RAPS Convergence is coming soon, and our team is excited to actively contribute to this year’s program with several speaking sessions. We’re covering wide-ranging regulations for medical devices and in vitro diagnostics in the EU and U.S.
Here’s a preview of what to expect. Pro tip: If you’re planning to attend and looking for practical tips, don’t miss the Solutions Circle sessions!
Safety and Performance Specifications - Challenges and Solutions
Dr. Jai Kutty, Vice President of Intelligence & Innovation, will be participating in this panel about safety and performance specifications under MDR. The rollout of MDR and subsequent MDCG documents brought additional expectations for the content and level of clinical evidence required. This session takes a deep dive into MDR, Annex XIV, Part A, section 1, which reads:
“... an indicative list and specification of parameters to be used to determine, based on the state of the art in medicine, the acceptability of the benefit-risk ratio for the various indications and for the intended purpose or purposes of the device.”
The panel will discuss what is expected from manufacturers for these quantifiable specifications, which are to be justified from the state of the art in medicine and used to judge the acceptability of the evidence collected toward the demonstration of the benefit-risk ratio for the device under evaluation. Presenters will share examples of appropriate safety and performance specifications, including the use of appropriate evidence sources from the state of the art to adequately justify the quantitative thresholds defined for each specification.
Using case studies from real-world examples, the session aims to stimulate discussions on how to derive such quantifiable specifications, also considering the type of clinical evidence coming from PMCF activities on the device under evaluation and the considerations to ensure the clinical endpoints used in PMCF studies can be aligned with the quantifiable specifications derived from the state of the art in medicine.
Goals for the session include sharing how to:
- Derive meaningful specifications that will be used to measure the safety and performance of a given medical device.
- Set acceptance criteria to these defined specifications and how to leverage suitable sources to justify the thresholds set.
- Align evidence coming from PMCF activities with the derived quantifiable specifications.
Essential Debate - Lessons Learned from the Implementation of the EU Regulations
Carlos Galamba, Vice President, IVD Intelligence and Innovation, will be participating in this panel about lessons learned in the EU. MDR and IVDR implementation has created challenges for stakeholders of all types, including manufacturers, notified bodies, consultants and competent authorities. This panel of notified body and industry voices will discuss some of these challenges and some of the lessons learned in the 15 months since the MDR date of application and three months from the IVDR date of application.
The primary goal of this session is for attendees to learn from the opportunities and challenges that others have already faced during the conformity assessment process. Everybody — manufacturers and regulators alike — is still learning, and sharing lessons learned is one of the most effective ways to make improvements as we all navigate these unknown waters.
A Lifecycle Case Study - Smooth Crossover Between Clinical Evaluation, PMCF and Risk Management
Dr. Celeste Maksim, Chief of Staff, Clinical & Post-Market Services, will be participating in the panel discussion about clinical evaluation, post-market clinical follow-up (PMCF) and risk management. A case study will be followed from the extraction of PMCF needs from the Clinical Evaluation Report (CER) through the execution of those identified PMCF activities to the use of the PMCF data in updated risk management activities.
In this panel discussion, a team of industry and notified body consultants will follow the path of end-to-end PMCF activities through a case study. This practical example includes:
- Identifying gaps in the clinical evidence of a device by means of the CER
- PMCF study design, conduct and data analysis
- Risk management updates
In this panel-style discussion, you will be able to ask the team questions based on the practical knowledge shared and leverage the process presented with your own products.
The session will take the form of a panel discussion, with the speakers giving some introductory remarks on key issues and then moving into an open Q&A.
Learning objectives for the session include:
- Key considerations in defining PMCF needs from the clinical evaluation and when to leverage PMCF data to address residual risks
- Considerations for successful execution of PMCF activities
- How to justify the study design and sources of evidence used for the specific methods of the PMCF activity
- How to set up risk acceptability criteria to be relevant for both pre-market and post-market risk management
- How to address “expected life” appropriately in PMCF activities and how to follow up on this data if collected
- The challenges of handling misuse and off-label use information when received
Solutions Circle: Developing IVDR Compliant Intended Purpose Statements That Serve the Business and Meet Notified Body Expectations
Presented by Celeste Maksim and Carlos Galamba, this solutions-oriented session will be chock-full of practical tips gained through the unrivaled collective knowledge at RQM+. Notified bodies are seeing that most intended purpose statements are noncompliant under IVDR. The requirement is not new (although it is now more specific), but because most products were previously self-certified under IVDD, manufacturers are finding that their intended purpose statements are falling short.
Changing an intended purpose statement can have a costly and resource-intensive ripple effect when global registrations are impacted, which is why creating a compliant statement that minimizes this ripple effect is key. This session aims to help manufacturers struggling to create compliant intended purpose statements that also balance business strategy.
Participants who attend this session will better be able to:
- Determine if their intended purpose statements are adequate.
- Implement a strategy for creating compliant intended purpose statements.
- Understand and educate their team on the most common pitfalls and solutions around developing an IVD intended purpose statement.
Solutions Circle: How to Efficiently Prepare Your eSTAR Submission
Anike Freeman, RQM+ Principal Consultant, will present practical strategies for efficient eSTAR submissions. MDR and IVDR are hot topics, but the regulatory landscape in the U.S. can’t be ignored. The Food and Drug Administration (FDA) has committed to developing “electronic submission templates that will serve as guided submission preparation tools for industry to improve submission consistency and enhance efficiency in the review process.”
To meet that commitment, the agency has issued draft and final guidance documents on electronic submissions for medical devices, developed the electronic Submission Template and Resource (eSTAR), and launched the voluntary eSTAR Program.
The currently optional, interactive eSTAR template may be used to prepare 510(k) and De Novo submissions. It is believed that the use of this template will eventually become required. Anike, a medical device consultant and former FDA reviewer will provide insight into:
- How to participate in the eSTAR program
- Key features of the eSTAR template
- Important tips and considerations when preparing submissions and ways to streamline the use of the eSTAR template
Participants will gain valuable information about how to properly complete and submit the eSTAR template to the FDA for review.
Meet RQM+ at the 2022 RAPS Convergence
We hope to see you there! Let us know if you would like to meet in Phoenix. Our team is here to help, and this is an excellent opportunity to connect with an RQM+ expert.
Whether you attend or not, register for the RAPS recap Live! show, where the RQM+ experts who spoke at the event will be sharing what they learned and what surprised them most as well as answering any lingering questions.