RQM+ Weekly Watch #27

RQM+ Recap

RQM+ news, recent content, and upcoming events.

3 Notified Bodies Join RQM+ Live! on Friday, 4 October

[Next Friday] Representatives from three notified bodies will join RQM+ Live! on Friday, 4 October, for Structured Dialogue: How to Engage with Notified Bodies. Hear directly from Alex Laan , Head of the IVD Notified Body at 英国标准协会 , ANDREAS STANGE , Senior VP MHS Regulatory & Quality at TüV SüD , and Tom Patten , IVDR/IVD International Manager at GMED . RQM+ VP of Global Regulatory Affairs, Jaishankar Kutty, Ph.D. , will moderate the panel.

?? Join the Discussion ???

New Technical Brief

Check out our latest technical brief by Edward B. , CEng, MIPEM, MIMMM – Manager, Intelligence & Strategic Execution. AI/ML-Enabled Medical Devices: Recognition & Reliance in the UK explores the new international recognition pathways for accessing the UK market and sheds light on how these evolving regulations could affect MedTech innovation, market access, and global collaboration.

?? Read the Technical Brief Here ??

Upcoming In-Person Events and What's Next

See the complete list here. ??

Featured Event ? The MedTech Conference (AdvaMed) - Toronto, Canada - 15-17 October

Visit us at booth 631 across from the food court to meet our team! We hope to see you there.

Europe

• The President of the European Commission, Ursula von der Leyen, has published a Mission letter Oliver Varhelyi (Commissioner designate for health and animal welfare) and includes an item on medical devices: “You will ensure the availability and competitiveness of medical devices, including by stepping up the implementation of the current framework and evaluating the need for potential legislative changes”.
• Team-NB published version 5 of their Code of Conduct for Notified Bodies under Regulations (EU) 2017/745 and (EU) 2017/746 "Improving implementation of the European CE certification of medical devices through the harmonization of Notified Bodies". For those interested to understand the limitations (and options) for structured dialogue with the notified bodies, there are some examples given as to what is permitted and what is not. See also Live! #83 “Structured Dialogue: How to Engage with Notified Bodies” on 4th October. Other changes of note include: removal of references to Directives and general update of references and terminology, compliance with Medical Device ?Coordination Group (MDCG) Guidance, Team-NB and NBCG-Med Papers, estimation of time needed for Technical Documentation review included, clarified requirements for unannounced audit, detailed explanation of re-certification requirements, and estimation of time needed for Corrective and Preventive Action (CAPA).
• COCIR published their views on what the future of medical device regulation in the EU should look like: COCIR POSITION ON THE FUTURE GOVERNANCE FRAMEWORK FOR THE MEDICAL TECHNOLOGIES SECTOR. It focuses on 3 main areas:?A. Ensuring availability of medical technologies for patients, health professionals and healthcare systems;?B. Supporting efficiency and predictability of the medical device regulatory system; and?C. Promoting innovation ecosystems for developers of innovative medical solutions in Europe.
• The UK's MHRA have published their Strategy for Improving Safety Communications 2024-2027. This include actions in response to recommendations from the public consultation, and mostly centers around safety communications to users/healthcare organizations and strengthening the communication pathways with the NHS and hospitals (e.g. through the liaison officers and device safety officers).
• The MHRA also published their Data Strategy 2024 - 2027. Specific to medical devices, there are intentions to improve device traceability and identification, to improve the connection of devices with longitudinal real-world data (RWD) and registry data, and to improve safety signal detection as part of Market Surveillance.
• Also in the UK, the Health Minister Baroness Gillian Merron announced that draft regulations for post-market surveillance of medical devices are set to be laid before Parliament by the end of this year. The draft of the PMS statutory instrument (SI) was sent to the WTO last autumn and has been hit by delays (due to an unexpected amount of comments on the draft text and changes in the UK parliament). At a high-level, when these new requirements are implemented and in force, it will bring the UK post-market surveillance requirements to a level similar to that required by the EU MDR and IVDR.
• The MHRA also announced that the recent implementation of a submission route for manufacturers for performance studies has now enabled the submission and approval of the first application for In Vitro Diagnostic devices under the EU IVDR in Northern Ireland.?
• Swissmedic have published an open letter to Swiss authorized representatives and importers to remind them of the upcoming deadline of 26th September 2024 that forms part of the transitional arrangements for legacy devices under the EU MDR.

United States and Canada

• The FDA issued three draft guidance documents relating to the Accreditation Scheme for Conformity Assessment (ASCA) Program: The Accreditation Scheme for Conformity Assessment (ASCA) Program, Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment and Biocompatibility Testing of Medical Devices.?
• The FDA also published draft guidance on Chemical Analysis for Biocompatibility Assessment of Medical Devices.?
• The FDA have published some recent classification/reclassification decisions: the quantitative viral nucleic acid test for transplant patient management as class II, and Cytomegalovirus (CMV) transplant assays (Cytomegalovirus Deoxyribonucleic Acid Quantitative Assay Devices Intended for Transplant Patient Management) from class III into class II, subject to premarket notification.
• Regulatory Affairs Professionals Society (RAPS) have released a recap video covering RAPS Convergence which took place in Long Beach California last week.

Rest of World

• It was World Patient Safety Day on 17th September. See more from the WHO here. See many posts here on LinkedIn via #WorldPatientSafetyDay, #GetItRightMakeItSafe, and #Patientsafety.

Recalls, FSCAs & Alerts

Class I Recall (United States)

• Ventilator Recall: Smiths Medical Removes ParaPAC Plus Ventilators due to Loosened or Detached Patient Outlet Connector
• Tracheostomy Tube Recall: Smiths Medical Removes Certain Bivona Neonatal/Pediatric and Adult Tracheostomy Tubes due to Manufacturing Defect that May Cause Tracheostomy Displacement or Decannulation
• Infusion Pump Correction: B. Braun Medical Inc. Issues Correction for lnfusomat Space Infusion System/Large Volume Pump, in addition to Infusomat Space Large Volume Pump Wireless, and lnfusomat Space Large Volume Pump Non-Wireless BATTERY PACK, Due to Faulty Occlusion Alarm
• Infusion Pump Administration Set Recall: Fresenius Kabi USA Removes Certain Ivenix Large Volume Pump Primary Administration Sets??

FDA Safety Communications

• Zimmer Biomet CPT Hip System Femoral Stem and Increased Risk of Thigh Bone Fracture - FDA Safety Communication

Other FSCAs / Safety Notices

• FSNs published in the UK: Field Safety Notices: 9 to 13 September 2024; Field Safety Notices: 16 to 20 September 2024

In the News

• FDA elevates recall as Zimmer Biomet phases out hip implant
• Zimmer pulls hip implant off the market due to fracture risk
• Smiths Medical recalls airway tubes over defect linked to more than 10 injuries

Warning Letters (United States)

• None this week.

Approvals, Clearances, and Classifications

Consumer Information: Minima Stent System?- P240003 (Renata Medical)

De Novo Reclassification Order - DEN230067 - Chronos?

De Novo Decision Summaries Updated:

• DEN210055 - N-SWEAT Patch
• DEN220048 - Neoasis
• DEN220033 - MISHATM Knee System
• DEN200029 - Parallel

In the news:

• GE HealthCare claims FDA clearance for amyloid imaging software
• GE Healthcare wins FDA clearance for Alzheimer’s imaging software
• FDA clears Senseonics' 365-day Eversense CGM implant
• Senseonics receives FDA clearance for one-year CGM

Articles We Read

Note: We're including some articles that are behind a paywall (MedTech Insight) and will clearly note when that's the case. We recognize some readers subscribe and links are helpful.

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Europe Related

• Orphan and paediatric medical devices in Europe: recommendations to support their availability for on-label and off-label clinical indications
• Updated Notified Body Conduct Code Explains Permitted 'Structured Dialogue' (MedTech Insight)
• Ursula Von Der Leyen Calls For EU Medtech Regulatory Framework To Be 'Stepped Up' (MedTech Insight)
• How To Transfer Surveillance Oversight For IVDs From One EU Notified Body To Another (MedTech Insight)
• Insights from RAPS Convergence 2024 Notified Body Forum ( Sean Smith on LinkedIn)
• Live report from RAPS Convergence 2024 (GMED's Tom Patten on LinkedIn)

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United States Related

• This Week at FDA: ASCA guidances, new clinical trial guidances, and more (RAPS)
• Convergence: FDA unlikely to meet TAP pilot recruitment goal for FY 2024 (RAPS)
• Convergence: Experts offer advice on when to submit a PCCP (RAPS)
• FDA draft guidance paves way for more real-world, point-of-care clinical trials (RAPS)
• Convergence: Experts offer advice on leveraging AI in regulatory (RAPS)
• FDA’s final guidance on DCTs adds clarity on HCP task log, inspection requirements, data variability (RAPS)
• The regulatory? landscape of ingestible medical devices in the United States (RAPS)
• Standardizing Packaging for ALL KINDS of Sterile Device Transportation (AAMI)
• The Top Five Cybersecurity Threats—The Future is Now (AAMI)
• How Technology & Finances Are Fostering Remote Health Reimagination (AAMI)
• A Detour Through Materials Science, Followed By A Climb Up A Rule 702 Hill (Drug & Device Law Blog)
• Learned Intermediary Rule Still Alive and Well in California (Drug & Device Law Blog)
• Advamed backs FDA’s misinformation draft, calls for updates on AI and deep fakes (MedTech Dive)
• FDA Hosts Webinar for Stage 1 Requirements under LDT Final Rule (FDA Law Blog)

General Industry News

• Convergence: Listen to patients when developing treatments for unmet medical needs, experts say (including RQM+'s own Allison Komiyama, PhD, RAC )

Stay In the Know

• Visit the RQM+ Knowledge Center for upcoming and on-demand content
• Subscribe to the RQM+ Device Advice podcast (Apple, Spotify)
• Subscribe to the RQM+ YouTube channel
• Follow RQM+ on LinkedIn for regular updates
• See RQM+ upcoming in-person events