MDCG 2023-3 rev.1 - Questions and Answers on Vigilance Terms and Concepts

In this Issue

From the Editor ✍🏽 | In Brief 💥 | What's Happening 🗓️ | Featured Interview 🔥 | Sections ✅ | Postscript 🐝

From the Editor ✍🏽

In case you missed last week's webinar, Biocomp Beyond the Basics, featuring subject matter experts Damian Matak, Łukasz Szymański, and Michelle Lott, RAC is now available on-demand.

Featured: Thanks to both Natasha Bankowski and Stefano Bolletta for sharing MDCG 2023-3 rev.1 - Questions and Answers on Vigilance Terms and Concepts.

🔥 Plus 13 more HOT new posts, Martin King’s Regulatory Roundup, and the latest 510(k) Clearances from Marcus Engineering, LLC.

Featured Webinar - This Wednesday!

Please join Martin King , Mark Omo from Marcus Engineering, LLC , and me this Wednesday for a lively look at how Gen-AI, including ChatGPT, Bing, and Co-Pilot, can have an immediate impact on your day-to-day RA/QA workflows.

In Brief 💥

• Natasha Bankowski and Stefano Bolletta shared the MDCG 2023-3 rev.1 guidance on vigilance terms under EU MDR and IVDR.
• The challenges facing the FDA’s new device chief were explored by DigiVidBIO.
• Andreas Stange shared a video on the latest developments in MDR and IVDR certifications.
• A summary of the FDA's medical device town hall, plus discussion of new standards were posted by Marina Daineko.
• EU MDR Compliance outlined the minimum sections required in a Risk Management plan under ISO 14971.
• The ultimate CAPA blueprint was shared by Georg Digel, detailing CAPA in 8 phases.
• Tibor Zechmeister shared five essential standards for MDR projects.
• The challenges of taking Gen-AI devices through the 510(k) pathway were highlighted by Yujan Shrestha, MD.
• J. David Giese discussed the FDA’s talk on synthetic versus real data.
• An explanation and history of PCCPs was shared by Etienne Nichols.
• TÜV Rheinland Medical Devices explained the EU’s regulatory requirements for using hazardous substances in medical device design.
• A must-know compliance tip checklist for medical device development was shared by Lisa Voronkova.
• Parul Chansoria broke down the importance of regulatory intelligence (RI) for medical devices.
• Beyond 510(k): Angelina L. shared an article about the FDA De Novo Pathway for moderate-risk devices.

Featured Posts 🔥

6 Things to Know About MDCG 2023-3 (Rev. 1)

In case you are wondering about the latest revision to MDCG 2023-3 guidance, shared this week by Stefano Bolletta and Natasha Bankowski , The updated MDCG 2023-3 guidance document provides expanded clarity on vigilance terms and concepts under the MDR and IVDR.

Key highlights include:

1. Inclusion of IVDR Scope - The guidance now includes IVDR alongside MDR for vigilance of diagnostic devices.
2. Detailed Definitions - A new table differentiates “incident” and “serious incident” with examples for IVDs.
3. Updated Flowcharts and Criteria - Revised flowcharts clarify incident reporting under MDR and IVDR.
4. Expanded Q&A Sections - New questions address reporting of errors, serious threats, and corrective actions.
5. Focus on Use-Error - Emphasizes reporting incidents caused by design or usability flaws.
6. Manufacturer Responsibilities - Stresses robust systems for timely reporting and field safety actions.

The new guidance provides detailed definitions and distinctions between “incident” and “serious incident” under the MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation).

Here’s What You Should Know:

Incident

Definition: Any malfunction, deterioration in the characteristics or performance of a device, inadequacy in labeling or instructions for use, or undesirable side effects that occur during the use of the device.

Criteria

• Does not necessarily result in harm but indicates that something went wrong.
• Incidents may still indicate a safety or performance concern that needs investigation to prevent escalation.

Serious Incident

• Definition: An incident that directly or indirectly leads to:
• Death of a patient, user, or other person.
• Serious deterioration in health, such as life-threatening conditions, permanent impairment, or significant disability.
• A serious public health threat, including widespread harm or risk to multiple individuals.

Criteria:

A higher threshold of severity compared to “incident.”

Directly linked to significant harm or risk of significant harm.

Key Differentiators

Aspect Incident Serious Incident

• Severity Minor issues or failures, no direct harm. Significant harm or risk of harm to health or the public.
• Outcome May indicate performance issues without severe impact. Results in death, permanent harm, or a public health threat.

Examples - Minor label errors.- Malfunction without injury. - Diagnostic error leading to delayed treatment.- Failure of a life-sustaining device causing injury or death.

Why This Matters

The distinction between incident and serious incident determines the level of urgency and reporting requirements:

• Incidents may need evaluation but not immediate reporting unless they have the potential to escalate.
• Serious incidents require prompt reporting to the competent authorities (“immediate” or “without undue delay”).

This differentiation ensures appropriate actions are taken proportionate to the risk and impact.

Sections ✅

Regulatory Roundup by Martin King - Week of November 4

Featuring the latest regulatory updates from: 📌 𝘌𝘨𝘺𝘱𝘵𝘪𝘢𝘯 𝘋𝘳𝘶𝘨 𝘈𝘶𝘵𝘩𝘰𝘳𝘪𝘵𝘺📌 𝘌𝘶𝘳𝘰𝘱𝘦𝘢𝘯 𝘊𝘰𝘮𝘮𝘪𝘴𝘴𝘪𝘰𝘯📌 𝘌𝘶𝘳𝘰𝘱𝘦𝘢𝘯 𝘔𝘦𝘥𝘪𝘤𝘪𝘯𝘦𝘴 𝘈𝘨𝘦𝘯𝘤𝘺📌 𝘌𝘶𝘳𝘰𝘱𝘦𝘢𝘯 𝘋𝘪𝘳𝘦𝘤𝘵𝘰𝘳𝘢𝘵𝘦 𝘧𝘰𝘳 𝘵𝘩𝘦 𝘘𝘶𝘢𝘭𝘪𝘵𝘺 𝘰𝘧 𝘔𝘦𝘥𝘪𝘤𝘪𝘯𝘦𝘴 & 𝘏𝘦𝘢𝘭𝘵𝘩𝘊𝘢𝘳𝘦📌 𝘔𝘦𝘥𝘪𝘤𝘪𝘯𝘦𝘴 𝘢𝘯𝘥 𝘏𝘦𝘢𝘭𝘵𝘩𝘤𝘢𝘳𝘦 𝘱𝘳𝘰𝘥𝘶𝘤𝘵𝘴 𝘙𝘦𝘨𝘶𝘭𝘢𝘵𝘰𝘳𝘺 𝘈𝘨𝘦𝘯𝘤𝘺📌 𝘔𝘌𝘋𝘚𝘈𝘍𝘌, 𝘕𝘦𝘸 𝘡𝘦𝘢𝘭𝘢𝘯𝘥📌 𝘕𝘔𝘗𝘈-𝘕𝘢𝘵𝘪𝘰𝘯𝘢𝘭 𝘔𝘦𝘥𝘪𝘤𝘢𝘭 𝘗𝘳𝘰𝘥𝘶𝘤𝘵𝘴 𝘈𝘥𝘮𝘪𝘯𝘪𝘴𝘵𝘳𝘢𝘵𝘪𝘰𝘯, 𝘗𝘙 𝘊𝘩𝘪𝘯𝘢📌 𝘚𝘰𝘶𝘵𝘩 𝘈𝘧𝘳𝘪𝘤𝘢𝘯 𝘏𝘦𝘢𝘭𝘵𝘩 𝘗𝘳𝘰𝘥𝘶𝘤𝘵𝘴 𝘙𝘦𝘨𝘶𝘭𝘢𝘵𝘰𝘳𝘺 𝘈𝘶𝘵𝘩𝘰𝘳𝘪𝘵𝘺📌 𝘚𝘸𝘪𝘴𝘴𝘮𝘦𝘥𝘪𝘤📌 𝘛𝘩𝘦𝘳𝘢𝘱𝘦𝘶𝘵𝘪𝘤 𝘎𝘰𝘰𝘥𝘴 𝘈𝘥𝘮𝘪𝘯𝘪𝘴𝘵𝘳𝘢𝘵𝘪𝘰𝘯 (𝘛𝘎𝘈), 𝘈𝘶𝘴𝘵𝘳𝘢𝘭𝘪𝘢📌 𝘜𝘚𝘈 𝘍𝘰𝘰𝘥 & 𝘋𝘳𝘶𝘨 𝘈𝘥𝘮𝘪𝘯𝘪𝘴𝘵𝘳𝘢𝘵𝘪𝘰𝘯 𝘍𝘋𝘈

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✅ 510(k)s at a Glance for the week of November 11, 2024

Marcus Engineering, LLC highlights 65 new FDA 510(k) cleared devices this week, including 16 first-time clearances 🚀.

For full details, visit Marcus Engineering’s report.

🗓️ What’s Happening

• Wednesday, Nov. 20 - Generative AI and You: Work smarter, faster, and more securely (workshop), featuring speakers Martin King, Mark Omo, and Sean Smith.
• Tuesday, Nov. 26 - Maximizing Structured Dialogue for MedTech, featuring speakers Bassil Akra , Marta Carnielli , Alex Laan , Tom Patten , and Michelle Lott, RAC .
• Thursday, Dec. 5 - US MedTech Market Access: Strategic Outlook 2025, featuring speakers Edward Dougherty and Richard Piquett .

Postscript 🐝

🇮🇹 I landed in Rome yesterday (hence this week's cover image) and am looking to interview subject matter experts on MedTech clinical development in Italy.

Any recommendations?

Sean 🐝