Summary

“When the notified body goes back and asks you (the manufacturer) for more information, they aren’t necessarily saying that whatever you have done is wrong.”

Clinical evaluation is a major requirement for medical devices under the EU regulation, and notified bodies must determine whether the evidence provided by the manufacturer is scientifically valid and sufficiently complete to answer the question of safety and effectiveness.

However, it is challenging to figure out what the expectations are, and it’s an unfortunate consequence of the way the system is setup. Notified bodies are not allowed to offer any guidance to manufacturers that could be considered consulting.

In this episode of the Let's Talk Risk Podcast, Naveen Agarwal and Amie Smirthwaite discuss the complexities of clinical evaluation for medical devices under the EU MDR. They explore the current regulatory landscape in Europe, the role of notified bodies, and the challenges manufacturers face in demonstrating safety and effectiveness. The conversation also delves into the necessity of clinical investigations, the evaluation of software and AI/ML devices, and the implications of ISO standards. Amie shares her career journey and offers valuable advice for aspiring professionals in the QA/RA field, emphasizing the importance of collaboration between engineers and clinicians in risk management.

Listen to the full 30-minute podcast or jump to a section of interest listed below.

Chapters

00:30 Introducing Amie Smirthwaite

01:11 The Current Landscape of Medical Device Regulation in Europe

04:08 Notified Body Perspective on Clinical Evaluation

10:00 Challenges in Clinical Evaluation for Manufacturers

13:49 Clinical Investigations: Are They Mandatory Under EU-MDR?

21:29 Navigating Software and AI/ML Device Evaluations

20:24 Status of ISO 18969 Standard on Clinical Evaluation

22:35 Amie’s Career Journey and Insights

25:27 Advice for Aspiring QA/RA Professionals

27:30 Understanding Clinical Risks and Closing Comments

Suggested links:

* LTR - Clinical evaluation is now more important than ever under EU-MDR.

* LTR: Clinical evaluation is a lifecycle process, not a one-time activity.

* MDCG23-7: Guidance on exemptions from clinical investigations.

Key Takeaways

* Clinical evaluation is essential for medical devices under EU MDR.

* The regulatory environment in Europe has become more stringent.

* Notified bodies assess the scientific validity of clinical evidence.

* Manufacturers face challenges in understanding regulatory expectations.

* Clinical investigations are not always mandatory for all devices.

* Software and AI/ML devices have unique evaluation considerations.

* ISO standards are evolving to better guide clinical evaluations.

* Career paths in QA/RA can be shaped by passion or financial incentives.

* Collaboration between engineers and clinicians is crucial for effective risk management.

* Clear guidelines from regulators would benefit manufacturers.

Keywords

Clinical evaluation, medical devices, EU MDR, notified bodies, regulatory challenges, clinical investigations, software devices, ISO standards, career advice, risk management

About Amie Smirthwaite

Amie Smirthwaite is leading expert in clinical evidence, with over 30 years’ postdoctoral experience in medical devices spanning new product development, quality and regulatory systems, and clinical evidence. She has been involved in the development of numerous MDCG and other clinical evaluation guidance documents and has served on multiple advisory board positions, including CORE-MD, HEU-EFS, NORE, and ICEPS, amongst others. She is an active participant in several ISO committees and created the original draft of ISO 18969, which recently advanced to CD stage. She currently works as an independent consultant advising on clinical and regulatory affairs, but previously worked for BSI, where she was Global Head of Clinical Compliance. Amie was BSI’s first Head of Clinical Compliance, building their clinical compliance team and leading the development of their clinical evaluation processes, leading to BSI’s successful designation as the first notified body under EU MDR. She also developed extensive training materials while at BSI, including clinical evaluation, technical documentation, risk management, ISO 13485, EU MDR, and biological evaluation. Amie is a Fellow of the Regulatory Affairs Professional Society.

Disclaimer

Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

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