_“We all know that processes or workflows we’re doing here in the US are very different in other areas. There might be different ways that users are using devices in certain countries…and so that’s one of those challenges of performing human factor testing in a real-world environment is being able to prove that these users are a subset or a simulation of what you would be seeing in real life.”_ – Dr. Victoria Barnosky

Key Discussion Topics:

• The future of human factors testing
• How to identify and analyze use risks
• Standardization vs. unique device requirements
• Disconnect between manufacturers and users

Our experts highlight the importance of maintaining progress towards IVDR compliance and registration despite the delay. The discussion also reflects on lessons learned from the EU MDR and examines how the IVDR extension might impact both new product registrations and updates to existing products previously regulated by the EU IVDD.

“I think manufacturers have to be very careful when they look at the dates. It's not actually that far, because if you work backwards, like 2025 is actually. If you can't 12 or 18 months period to get a technical file reviewed, you have to send your technical file like almost right now.”

-Christelle Perrin-East, Sr. Regulatory Consultant

Key Discussion Topics:

• The IVDR Extension
• Lessons from the MDR
• Negative Impact of the IVDR Extension
• Impact on Existing Products Covered by the IVDD

Links:

Blog – Navigating the Transition: Understanding the EU’s Proposed Amendments to IVDR

Blog – MDCG 2022-11Rev 1: Urgency for MDR and IVDR Compliance

RAQA Café Podcast – The EU IVDR: What Do You Need to Know?

Dr. Beatriz Rodriguez Grande, who began her career in the medical device industry as a Preclinical Research Scientist in 2010, joined NAMSA via AKRN Scientific Consulting in 2021. She now leads as Team Leader for Medical Writing Services and Manager Consulting GTC. Dr. Sean Bird started his career at Cook Medical as a Regulatory Scientist in 2012 and transitioned to NAMSA in 2021, where he serves as a Principal Medical Writer. Together, they bring a wealth of knowledge on the regulatory requirements of medical writing in our industry.

Throughout our conversation, we examine the information shared among risk management, clinical evidence and post-market surveillance. We also share strategies for maintaining consistent messaging and emphasize the importance of making sure your reports properly document your product’s requirements and how those requirements are met.

“… know when you will be able to integrate the information in an efficient way so that you don't duplicate efforts.” – Dr. Beatriz Rodriguez Grande

“The CER is supporting the presence on the European market, European Healthcare is the government, right? So, what is the benefit of this device? Why is this company or country paying for the device, what is the benefit?” – Dr. Sean Bird

Discussion topics include:

• Tailoring your documentation to your targeted audience
• Coordinating information and actions
• Benefit/risk strategies
• Setting the bar and demonstrating you’ve met it through data-backed evidence

Links:

Clinical Data Requirements Under MDR: A Panel Discussion | NAMSA

Both Paul and Matt bring a wealth of experience to the table, having previously worked for Notified Bodies themselves. They have since leveraged their knowledge to aid numerous NAMSA clients in navigating the nuanced interaction process with their respective reviewers.

“You know the review system should be you get the first round of questions to answer. If you get a second round, it’s because you know you didn't answer the first round properly.” – Paul Risborough

Discussion topics include:

• Communication between manufacturers and Notified Bodies
• Reviewing and responding to reviewer questions
• Maintaining good relationships
• Dispute resolutions

“A Risk Management System is not documentation…, make sure you have a process in place, make sure you have management responsibility defined, make sure you have competent people, … then we talk about how you document a risk management plan and a risk management file… The documentation is just an output of a Risk Management System” – Dr. Naveen Agarwal (Principal and Founder, Creative Analytics Solutions, LLC)

Discussion topics include:

• Developing and maintaining a Risk Management System
• Having a quality risk mindset
• Focusing on integrating risk management as a process and not a document

Helpful Links:

Naveen Agarwal, Ph.D. | LinkedIn

Effective Implementation of EN ISO 14971 Medical Device Risk Management Standard | NAMSA

Industry Update: U.S. FDA Quality Management System Regulation | NAMSA

Let's Talk Risk!

Dr. Agarwal’s mission is to help elevate the collective capability in risk management throughout the medical device industry to accelerate innovation and launch highly safe and effective products for patients and doctors.

“...as a risk practitioner, the first conversation we need to have is creating an understanding of what we are trying to accomplish, because its required or its expected... ” – Dr. Naveen Agarwal (Principal and Founder, Creative Analytics Solutions, LLC)

Discussion topics include:

• Developing and maintaining a Risk Management System
• Having a quality mindset
• Product Development cycle

Helpful Links:

1. Naveen Agarwal, Ph.D. | LinkedIn
2. Effective Implementation of EN ISO 14971 Medical Device Risk Management Standard | NAMSA
3. Industry Update: U.S. FDA Quality Management System Regulation | NAMSA
4. Let's Talk Risk!

Join our hosts for the eighth installment of the NAMSA RAQA Café Podcast, where they sit down with Wendy Schroeder (NAMSA Principal Product Development Strategist–IVD, Clinical) to discuss valuable insights into clinical investigations and clinical evaluations and examine the advantages and risks associated with participating in a clinical trial.

“When you are looking at an investigational product, investigational device, you typically have to put that device into a clinical investigation where you use the device on human subjects and you demonstrate that it is safe and that it’s effective ” – Wendy Schroeder (Principal Product Development Strategist–IVD, Clinical)

Discussion topics include:

• Clinical evaluation
• Intricacies of clinical trials
• Benefits/risks of participating in a clinical study
• Respiratory season for clinical trials (flu and cold research season)

Helpful Links:

1. NAMSA Webinar: Infectious Disease Diagnostic Devices: The Big Move

2. NAMSA/AdvaMed Webinar: Clinical Trial Site Budgeting – Risk Mitigation or Budget Control?

3. NAMSA Blog: Clinical Trial Cost Analysis with Site Budget Estimates

“In regards to the IVDR you have three things that you have to formalize, you have scientific validity, clinical performance and analytical performance. ” – Warren Jameson

Discussion topics include:

• What is IVDR?
• What is the major change compared to the EU’s In Vitro Diagnostic Directive (IVDD)?
• What is the true impact on small, mid-size and large businesses?
• Has there been a shift in the time it takes for getting IVDs to market in the EU?

Helpful Links:

• EUR-Lex - 02017R0746-20170505 - EN - EUR-Lex (europa.eu) - Regulation (EU) 2017/746

• MDCG_2022-2_en.pdf (europa.eu) - MDCG 2022-2 Guidance on general principles of clinical evidence for in vitro Diagnostic medical devices (IVDs)

• MDCG 2021-4 en.pdf (europa.eu) – MDCG 2021-4 Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746

• https://www2.namsa.com/RAQA_Cafe_IVDR_Clinical_Evidence

During our discussion, Jack delves into common mistakes that are observed when conducting In Vivo studies, ways in which to mitigate these mistakes and variances pertaining to In Vivo study expectations in different global markets.

“We reach out to other experts and bounce ideas. Am I missing something based on your experience?” – Jack Risdahl (Principle Product Development Strategist)

Discussion topics include:

• Institutional Animal Care and Use Committee (IACUC) and how a small company can navigate animal welfare requirements
• How to engage with a cross-functional team to rectify mistakes
• Study considerations and best practice for evaluations

Helpful Links:

• https://www.healthline.com/health-news/animal-testing-why-the-fda-is-exploring-more-alternatives
• https://www.science.org/content/article/fda-no-longer-needs-require-animal-tests-human-drug-trials

In this episode, our hosts will sit down with NAMSA UK-based Medical Device Regulation (MDR) experts, Matt Royle (Principal Regulatory Consultant) and Paul Risborough (Principal Regulatory Consultant) to discuss all things RAPS, including:

• Highlights and takeaways from the RAPS EU Convergence Conference
• Best practices for writing effective MDR-compliant Periodic Safety Update Reports (PSURs)
• Lessons learned when documenting benefit-risk in recent projects

… and much more!

During the discussion, Sonia and Duan delve into the differences between SiMD and SaMD for In Vitro Diagnostics (IVD), as well as FDA criteria deemed important during evaluation of safety and effectiveness of IVD software with one or more device functions.

“Things have changed in diagnostics tremendously; they have brought diagnostics to the forefront as a norm rather than an afterthought” – Sonia Lecce (Principal IVD Regulatory Consultant)

Discussion topics include:

• What criteria classify a device as either SiMD or SaMD for IVDs?
• What regulatory agencies are taking the lead on future IVD regulations?

During the discussion, they delve into the differences between SiMD and SaMD, as well as FDA criteria deemed important during evaluation of the safety and effectiveness of device software with one or more device functions.

“I get a lot of questions related to the FDA guidance document. Most sponsors do not really take that guidance document seriously and the FDA does. Every element in that guidance document needs to be considered. ” – Monica Montanez, Principle Product Development Strategist

Discussion topics include:

• What criteria are utilized to classify a device as either SiMD or SaMD?
• Are certain regulatory agencies taking the lead on future regulations?
• How can we better understand digital health trends?

“When you are doing your 510(k), you should set up your expectations with management far, far ahead so they don’t have the expectation that 90 days later they are going to be able to sell the product. Setting these expectations is one of the things the regulatory person should do… The whole process generally takes four to six months.” – Angela Mallery

Discussion topics include:

• FDA Refusal to Accept (RTA) screening process 510k submissions
• RTA Checklist (Traditional 510k, Abbreviated 510k, Special 510k)
• FDA eSTAR Program, a voluntary electronic submission template

“I think that communication is important with your consultant or CRO. Finding one that you can communicate with, that they understand your needs, that you can have an open conversation, … that is really important.” - Carol Buchert, Senior Manager, NA Regulatory & Quality

Discussion topics include:

• Determining if the consultant’s technical experience matches your development needs
• Navigating communication expectations
• Defining clear responsibilities during project scoping
• Understanding future support capabilities