RQM+ Weekly Watch #47

RQM+ Recap

RQM+ news, recent content, and upcoming events.

[Webinar] RWE for Orphan Devices Under New EU Guidance & Beyond

Join Bethany Knorr Chung, PhD, RAC and Amelia Hufford tomorrow, March 5th, to learn how Real-World Evidence supports the assessment and management of orphan devices. The 45-minute webinar is designed for regulatory affairs, clinical affairs, and product managers.

They'll cover:

?? How orphan devices are defined and the biggest misconceptions

?? The level of clinical evidence needed for pre-market approval

?? How manufacturers can justify orphan status and data sufficiency

?? The role of bias and health equity in data transferability

?? Strategies for sourcing and collecting post-market clinical data

?? Reserve your seat

Introducing the New RQM+ Brand Identity

We don’t build medical devices. We make them ???????????? ??????????.

We don’t invent life-changing diagnostics. We make sure they ???????? ???????????? ??????????????????.

We don’t create combination products. We make them ???????????????????? ???? ????????????????.

At RQM+, we don’t make MedTech. ???? ???????? ?????????????? ????????????.

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?? Watch a video featuring RQM+ and Jordi Labs, an RQM+ Company employees here.

Hear Margot Borgel on MedTech Leading Voice This Friday

Join MDG Premium and MedTech Leading Voice for a special International Women’s Day event featuring Margot Borgel, Ph.D. , Ph.D., Director of IVD Regulatory Affairs, at RQM+ . This interactive discussion will explore the regulatory and market challenges for women’s health technologies, the impact of bias in medical device development, and the importance of gender representation in clinical trials.

Sign up here. ??

Europe

• Swissmedic have updated their guidance for Field Safety Corrective Actions (FSCA).
• MedTech Europe, alongside other trade associations, have published an urgent call for clarity on clinical strategy discussions.
• The European Patients' Forum (EPF) have published their analysis of the European Health Data Space Regulation.?
• The UK government have published their response to part of the recent consultation on UK medical device legislation: Consultation on Medical Devices Regulations: Routes to market and in vitro diagnostic devices. Four of the pieces of assimilated law that form part of Great Britain’s current regulatory framework are due to be sunsetted – i.e. they are due to expire – on 26 May 2025 (before any new Regulations are in force). Based on their review of the consultation, the UK government intends to amend the Medical Devices Regulations 2002 to revoke the sunset date of the following pieces of assimilated EU law:
• — Commission Decision 2002/364 on the common technical specifications for in vitro diagnostic medical devices sets out technical requirements that certain in vitro diagnostic medical devices must meet to demonstrate compliance with essential requirements when they are placed on the market or put into service.
• — Commission Regulation (EU) No 207/2012 on electronic instructions for use of medical devices establishes the conditions under which the instructions for use of medical devices may be provided in electronic form instead of in paper form and sets out certain requirements concerning instructions for use in electronic form which are provided in addition to complete instructions for use in paper form.
• — Regulation (EU) No 722/2012 concerning particular requirements for medical devices manufactured utilising tissues of animal origin lays down requirements in relation to the placing on the market and putting into service of medical devices, including active implantable medical devices, manufactured utilising animal tissue which is rendered non-viable or non-viable products derived from animal tissue. The Regulation applies to animal tissues, as well as their derivatives, originating from bovine, ovine and caprine species, deer, elk, mink and cats.
• — Regulation (EU) No 920/2013 on the designation and the supervision of approved bodies sets out further requirements on the designation of approved bodies and a list of elements to be included in the interpretation of the relevant annexes of the Medical Devices Directive and Active Implantable Medical Device Directive on minimum criteria to be met for the designation of bodies.
• NICE (UK) have published various new and updated guidance documents during February 2025, including updates on diagnosis of breast cancer, the use of AI-enabled software in chest x-ray analysis and digital technologies used in self-management of COPD.?

United States and Canada

• The CDRH New page has still not been updated since 23rd Jan 2025. No new guidance documents have been published since 5th Feb 2025.

Rest of World

• Nothing of note to report.

Recalls, FSCAs, and Alerts

Class I Recalls (United States)

• Ablation Catheter Correction: Biosense Webster Updates Use Instructions for Varipulse due to High Rate of Stroke or Transient Ischemic Attack
• Patient Table Correction: Philips Updates Use Instructions for Allura and Azurion Systems due to Patient Fall Risk from Incorrectly Positioned Mattresses
• Power Assist Device Recall: Max Mobility/Permobil Removes SpeedControl Dial Component Used with SmartDrive MX2+ Power Assist Device Due to Risk for Motor to Be Unresponsive to the User
• Regard Newborn Kit Recall: ROi CPS, LLC Removes Certain Newborn Kits Due to a Recalled Component, the Neo-Tee T-Piece Resuscitator With An Undersized Controller Spring
• Endoscope Instrument Recall: Olympus Removes Single Use Guide Sheath Kits Due to Risk for Radiopaque Guide Sheath Tip Detaching During Procedures?

FDA Safety Communications and Recalls

• Point de situation sur les appareils de ventilation Philips
• Implants de renfort pariétal pour le traitement des hernies abdominales et inguinales : nos actions pour assurer la sécurité des patients

Other FSCAs and Safety Notices

FSNs published by ANSM:

• PACS – DeepUnity Viewer 2.x – DH Healthcare GmbHInformation destinée aux services d'imagerie
• Dispositifs médicaux?PUBLIé LE 28/02/2025 - MIS à JOUR LE 28/02/2025Logiciels (divers) – Hedia Diabetes Assistant – Hedia ApSInformation destinée aux utilisateurs de l'application
• Pousse-seringue, pompe à perfusion, base de perfusion – Exelia SP, Exelia VP, Exelia Combox, Exelia Therapy Manager – Fresenius Kabi AG - Fresenius VialInformation destinée aux établissements de santé
• Appareils de ventilation BiPAP A30, BiPAP A30 EFL, BiPAP A30 Hybrid, BiPAP A40, BiPAP A40 EFL, BiPAP A40 Pro - Philips RespironicsInformation destinée aux pharmacies d'usage intérieur et prestataires de santé à domicile
• Ventilateur (accessoire), capnographe - Lignes de prélèvement et d'échantillonnage CO2 Microstream avec connecteur Luer – Covidien / MedtronicInformation destinée aux pharmacies d'usage intérieur des établissements de santé
• Automate DxI 9000 Access Immunoassay Analyzer – Beckman CoulterInformation destinée aux laboratoires d'analyses de biologie médicale
• Sonde d'intubation endotrachéale – Intubation oral/nasal endotracheal tube – Smiths Medical (une société ICU medical)Information destinée aux pharmacies d'usage intérieur, établissements de santé
• Sous-ensemble de stimulateurs cardiaques implantables Assurity et Endurity (plusieurs références) - AbbottInformation destinée aux établissements de santé et aux cardiologues/rythmologues
• Hématologie – Capteur Hb-sensor type III complete pour automate Combiline 2 – EschweilerInformation destinée aux laboratoires d'analyses de biologie médicale
• Laroscorbine 1 g/5 ml, solution injectable I.V. en ampoule – Bayer Healthcare SASNiveau de rappel : officines, établissements de santé et circuit de distribution pharmaceutique
• Ecouvillons à usage unique pour nettoyage d’endoscopes – LTA Medical (Getinge)Information destinée aux pharmacies d'usage intérieur des établissements de santé
• Mobile de radiologie – DR-XD 1000 / FDR Nano – FujifilmInformation destinée aux établissements de santé et centres d'imagerie médicale
• Circuit de ventilation patient – ID Circuit Flex 220 et VentStar Flex 220 – Dr?gerwerk AG & Co. KGaAInformation destinée aux pharmacies d'usage intérieur des établissements de santé
• Automate DxI 9000 Access Immunoassay Analyzer – Beckman CoulterInformation destinée aux laboratoires d'analyses de biologie médicale
• Biochimie – Réactif Atellica CH Diluent – Siemens Healthcare DiagnosticsInformation destinée aux laboratoires d'analyses de biologie médicale
• Kit d'irrigation/aspiration laparoscopique – Fairmont MedicalInformation destinée aux distributeurs et aux pharmacies à usage intérieur des établissements de santé
• Immuno-Hématologie – Réactif ID-DiaCell I-II-III – DiaMedInformation destinée aux laboratoires d'analyses de biologie médicale
• Pompe à insuline externe – MiniMed 640G, MiniMed 740G, MiniMed 780G, Minimed Paradigm Infusion – Medtronic MiniMed – Changements de pression d’airInformation destinée aux prestataires de santé à domicile

FSNs published in the UK: Field Safety Notices: 17 to 21 February 2025

• Abbott: Assurity, Endurity
• Baxter: Welch Allyn non-automated blood pressure gauges
• BD: BD PCR Cartridge
• Beckman Coulter: DxI 9000 Access Immunoassay Analyzer
• Beckman Coulter: DxI 9000 Access Immunoassay Analyzer
• Cook Medical: Hemospray Endoscopic Hemostat
• GCE: GCE Combi valve
• Human Care: Altair Lifting Solutions
• Medtronic: Microstream Advance and Luer Sampling Lines?
• Siemens Healthineers: Atellica CH Diluent
• Smiths Medical: Intubation ORAL/NASAL Endotracheal Tube

In the News:

FDA updates Boston Scientific's serious pacemaker recall

Warning Letters (US)

• None this week.

Approvals, Clearances, and Classifications

None to report this week.

In the news:

• Sebela’s Miudella Is First Hormone-Free IUD To Win FDA Approval In 40 Years
• Medtronic Widens Parkinson’s aDBS Opportunity With Key US Approvals
• Tandem’s insulin pump tech wins FDA nod for Type 2 diabetes
• FDA approves Medtronic’s adaptive DBS implant for Parkinson’s

Content We Read or Listened To

Note: Some articles are behind a paywall (MedTech Insight) and are noted as such.

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Europe Related

• New Leadership and a focus on Software (MHRA)
• Euro Roundup: UK consultation finds support for retaining EU medtech laws? (RAPS)
• European Commission launches consultation on electronic instructions for use ?(RAPS)
• EU Urged To Prioritize Clinical Strategy Talks In Pre-Submission Process (MedTech Insight)
• EU Law First Up As UK MHRA Reopens Work On Pre-Market Medtech Regulation (MedTech Insight)
• New Deadlines Loom For Medtech And App Developers Under New EU AI Act (MedTech Insight)
• A Blueprint For The Future: Germany’s Medtech Sees Chance In More Government Roundtables (MedTech Insight)
• Barcelona Health Hub: Where Digital Health Innovation Meets Historic Art Nouveau (MedTech Insight)
• Non-EU Medtech Firms May Face Suits Under New Product Liability Directive (MedTech Insight)
• NSAI Hopes To Reverse IVDR Suspension By Irish National Authority In March (MedTech Insight)
• Have Your Say: Should The EU Have eIFU For All Professional Use Devices? (MedTech Insight)
• New German Government Told To Keep Medtech Outside Tariffs Bargaining (MedTech Insight)

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United States and Canada Related

• This Week at FDA: Makary confirmation hearing, HHS to limit notice and comment for rules (RAPS)
• HHS tells staff they are not required to respond to DOGE email ?(RAPS)
• FDA rehires some laid-off staff, though some fear lasting damage to trust ?(RAPS)
• Court Decision On LDTs ‘Quite Realistic’ Before May Deadline, Says ACLA Attorney? (MedTech Insight)
• Round 2: FDA Braces For Next Set Of Staff Cuts? (MedTech Insight)
• ‘Most, If Not All,’ CDRH Staffers Back On The Job? (MedTech Insight)
• ‘I Owe A Debt Of Gratitude To America,’ Says FDA Staffer Whose Termination Was Rescinded? (MedTech Insight)
• CAP urges HHS to revoke lab developed test rule, citing Trump order
• BioZorb Decision Hits the Mark (Drug & Device Law blog)
• Bair Hugger Rule 702 Disappointment Visits the Lehigh Valley (Drug & Device Law blog)
• Collateral Litigation As A Deterrent Of Bogus Research? (Drug & Device Law blog)
• In Uncertain Times, Good Compliance and Quality Communication Habits Can Offer a Port in the Storm (FDA Law Blog)
• The ICH E6(R3) Guideline: A Major Update to Good Clinical Practice (FDA Law Blog)
• FDA reinstates some CDRH staff after layoffs
• U.S. Shifts AI Policy, Calls for AI Action Plan ?

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Global Items and General Industry News

• Could transparent model cards with layered accessible information drive trust and safety in health AI?

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