Benefit/Risk Ratio or Profile? Raising the Discussion for Medical Devices

In this Issue

From the Editor ????| In-Brief?? |?Featured ???| Sections ? | Postscript ??

From the Editor????

Now and then, a topic strikes a chord. This week,?EU MDR Compliance?raised the question: Benefit/Risk Ratio or Profile? This sparked a lively discussion summarized in this week's featured post.

?? Plus, 14 other super-useful new posts and Martin King's Regulatory Roundup.

In case you missed it... More than 814 people registered for last week’s “CE-Certification vs FDA Strategy: MedTech Startup Masterclass,” with expert panelists Ronald Boumans , Michelle Lott, RAC , and Nika Mendelev .

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In Brief ??

• Kev Eley shared interesting perspectives on cybersecurity in healthcare in his recent article
• The importance of regulatory intelligence in maintaining compliance, detailed by LFH Regulatory Limited
• Judith de Wilde overviewed a guide on how to prepare for article 10a MDR amendment (2024/0021/COD)
• Stefano Bolletta explained the new OJEU Regulation (EU) 2024/1860 and its implication
• IMDRF Guidance on standardization for medical devices, and more shared in Monday News by Marina Daineko
• The new EU Machinery Regulation (EU) No. 2023/1230 and its implications, outlined by SASSE Elektronik GmbH
• Geert Van Peteghem underscored a useful complete guide to 510(k) submissions for medical devices?
• Sandy Su explored black box AI and its challenge for healthcare adoption in her recent article
• A helpful infographic on medical device reimbursement was uncovered by Yujan Shrestha
• Suman Mishra highlighted an interesting article on misinformation about medical devices and prescription drugs??
• MDCG 2020-16 guidance sets new classification rules for IVDs: detailed in a recent RAPS article by Joanne Eglovitch
• Maanasa B. underscored the Australian regulatory requirements and their principles?
• Geneviève Laumen detailed tips on determining the benefit-risk ratio during clinical evaluation of medical devices
• An overview of the new FDA draft guidance, Use-Related Risk Analysis (URRA) for drugs, biologics, and combination products, was explained by Suttons Creek, Inc.

Sections ?

Featured Post ??

This popular post by EU MDR Compliance?explains the differences between quantitative (ratio) and qualitative (profile) methodologies for benefit-risk analysis in medical devices.

It highlights when each is appropriate and suggests that a combination of both can provide a comprehensive evaluation. It emphasizes the importance of using state-of-the-art data and thoroughly documenting the magnitude, probability, and duration of benefits and risks.

Here's a quick summary of the discussion it sparked:

• Tibor Zechmeister: Advocates for a mix of both qualitative and quantitative methods to avoid biases and ensure a comprehensive analysis.
• Vincent Castéras : Believes in the qualitative approach due to the subjective nature of risk/benefit analysis, as shown during the COVID-19 era.
• Sai Krishna M. : Emphasizes the importance of accurate data categorization and considering harm severity in quantitative analysis to avoid misrepresentation.
• Edward B. : Prefers qualitative evaluation over quantitative ratios, arguing that numbers alone cannot capture the complexity of the analysis.
• Vincenza Ricciardi : Finds the comparison between B/R ratio and profile methods useful for analysis, emphasizing the need for balance.
• Dr. Anita Joshi : Finds the article informative and appreciates the clarification on qualitative and quantitative methodologies.
• Rai Chowdhary : Warns that quantitative ratios can lead to distorted perceptions, referencing works by Daniel Kahnemann and Amos Tversky.
• Ritika Agarwal: Stresses distinguishing between B/R ratio and profile methodologies for effective EU MDR compliance.

What do you think?

? Weekly Regulatory Roundup

By Martin King, July 8, 2024

In This Week's Regulatory Roundup

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Postscript ??

Destination Malaga, Spain

Registration is now open for TEAM-PRRC THIRD ANNUAL SUMMIT: 2024, October 17 & 18; Malaga, Spain.

Join me there.