RQM+ Weekly Watch #38

RQM+ Recap

RQM+ news, recent content, and upcoming events.

📥 Cybersecurity Presentation and Panel Now On Demand

Medical device manufacturers must comply with federal regulations and address risks at every stage — pre- and post-market. Watch the on-demand version of last week's event and learn:

➡️ What makes a device a cyber device and why it matters to you

➡️ How to ensure compliance with FDA and EU MDR cybersecurity expectations

➡️ The strategies, tools, and processes that protect your connected devices and patients

The all-star cast of panelists includes Allison Komiyama, PhD, RAC, Hrishikesh Gadagkar, Mirko Raner, and Jaishankar Kutty, Ph.D.

👉 Watch Now and Download the Slides Here

Europe

• In readiness for the application of the new Article 10a requirements under the EU MDR and IVDR (Regulation 2024/1860), and following on from the recently published reporting form template, the Q&A document has been updated to revision 1 to include references to the reporting form template.
• Team-NB issued a press release regarding the Implementation of Class D oversight by the European Reference Labs (EURL). Those Notified Bodies that are designated against the EU IVDR (EU Regulation 2017/746) have now endorsed the consolidated template for the multi services agreement (MSA) with the EURLs.
• The European Commission have published a call for evidence as part of their targeted evaluation of the EU MDR and IVDR. The targeted evaluation will help the Commission take stock and assess whether the rules:
• — are effective, efficient and proportionate;
• — meet current and emerging needs;
• — align with other actions;
• — have EU added value.

The feedback period is now open and is due to close on 21st March 2025 (midnight Brussels time).

• The EU Member States have endorsed the strategy for the second phase of the COMBINE project.
• A reminder that Regulation (EU) 2023/988 on general product safety applies from 13th December 2024.
• MedTech Europe have published a statement regarding the need for a roadmap and guidance on the HTA Regulation.
• Team-NB have published some high-level data on their members and activities.
• Swissmedic have published v2.1 of their information sheet on the content requirements for a CAPA plan (for Economic Operators responding to non-conformities identified during market surveillance by authorities as per Chapter 9 of the MedDO).
• The MHRA have published an updated version of their “Medical Devices Regulatory Reform. Roadmap to implementation”, which provides a bit more specificity around activities and timings (compared to the original version). Summary….2025 is going to be a busy year for those involved in developing, publishing, interpreting and implementing UK legislation and guidance for medical devices and IVDs.
• Also in the UK, NHS England has commenced a review of digital clinical safety standards DCB0129 and DCB0160. These two documents relate to clinical risk management for the design, installation, maintenance and use of health IT systems.

United States and Canada

• Nothing of note this week.

Rest of World

• Nothing of note this week.

Recalls, FSCAs, and Alerts

Class I Recall (United States)

• None this week.

FDA Safety Communications

• Early Alert: Infusion Pump Issue from Fresenius Kabi USA. (this is the first in the FDA's new communications pilot, and the FDA are still collecting information before confirming it as a recall)
• Safety and Availability Concerns with VasoView HemoPro Endoscopic Vessel Harvesting Systems - Letter to Health Care Providers (Updated)

Other FSCAs / Safety Notices

• FSNs published in the UK: Field Safety Notices: 2 to 6 December 2024

In the News

• FDA’s First ‘Early Alert’ Under New Communications Pilot Targets Fresenius Infusion Pumps (MedTech Insight)
• FDA issues first early alert with Fresenius Kabi infusion pump recall
• Artivion says cybersecurity incident has disrupted order, shipping processes

Warning Letters (US)

• None reported this week.

Approvals, Clearances, and Classifications

Consumer Information:  nAbCyte Anti-AAVRh74var HB-FE Assay - H230005 (LabCorp Drug Development)

De Novo Decision Summaries (Updated):

• DEN220047 - Galen ES Cooperative Surgical Assistant Platform, Galen ES
• DEN220052 - BrachyGel Vaginal Hydrogel Packing System

In the news:

• Endoquest robotic system gets FDA OK to launch clinical trial
• Artivion nets FDA greenlight for aortic tear implant
• FDA OKs AngioDynamics pulsed field ablation for prostate cancer

Articles We Read

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

Europe Related

• Festive reflections on Med Tech (MHRA)
• ‘Don't Let Drug Regulators Handle Medical Devices: EU Needs Dedicated Agency’' (MedTech Insight)
• Have Your Say: European Commission’s Targeted Evaluation Consultation Open (MedTech Insight)
• Five AI Technologies Selected For UK MHRA’s AI Airlock Pilot (MedTech Insight)
• UK Medtechs Fear Government Tax Rise Will Push Them Over The Edge (MedTech Insight)
• The Complex Landscape Of Reprocessing Single-Use Medical Devices In Europe (MedTech Insight)
• Centralized Medtech Regulation: Which Way Should The EU Go? (MedTech Insight)
• Understanding the EU In Vitro Diagnostic Regulation (IVDR) and its impact (SGS)
• Recon: MHRA AI Airlock candidates selected; Gilead tests yearly anti-HIV shot (RAPS)
• Euro Roundup: MHRA updates on medical device regulatory reforms (RAPS)
• SDLC Quality Gates: Saving you time in your SaMD certification (Scarlet)

United States and Canada Related

• Shedding light on essential drug delivery outputs (TOPRA)
• Public-Private Partnerships Praised Amid Criticism of COVID-19 Response (MedTech Insight)
• AI Challenges Tops ECRI’s List Of Health Technology Hazards For 2025 (MedTech Insight)
• Can COVID-19 Failures Help Prep Health Officials For ‘Disease X?’ Yes, Experts Say (MedTech Insight)
• Stakeholders urge greater collaboration to promote innovative manufacturing (RAPS)
• AdvaMed, Abbott ask FDA to prioritize cybersecurity, PCCP and LDT guidances next year (RAPS)
• Patient preference information: Stakeholders seek clarity on terms, postmarket usage (RAPS)
• What Makes a Sterilization Science Award Winner? We Interview the First (AAMI)
• Hurricane Recovery and Repairing the IV Supply Chain (AAMI)
• FDA’s first Digital Health AdComm meeting mulls promises & perils of Generative AI (Hogan Lovells)
• 4 takeaways from the FDA’s first digital health advisory committee
• How Trump’s second term will affect the medtech industry
• AI-enabled apps top ECRI’s list of health tech hazards in 2025

Global Items / General Industry News

• Asia-Pacific Roundup: Singapore’s HSA starts SaMD change management pilot project (RAPS)

Stay Ahead In 2025 with RQM+

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