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
Introducing the New RQM+ Brand Identity
We don’t build medical devices. We make them 𝗺𝗮𝗿𝗸𝗲𝘁 𝗿𝗲𝗮𝗱𝘆.
We don’t invent life-changing diagnostics. We make sure they 𝗺𝗲𝗲𝘁 𝗴𝗹𝗼𝗯𝗮𝗹 𝘀𝘁𝗮𝗻𝗱𝗮𝗿𝗱𝘀.
We don’t create combination products. We make them 𝗮𝗰𝗰𝗲𝘀𝘀𝗶𝗯𝗹𝗲 𝘁𝗼 𝗽𝗮𝘁𝗶𝗲𝗻𝘁𝘀.
At RQM+, we don’t make MedTech. 𝗪𝗲 𝗠𝗮𝗸𝗲 𝗠𝗲𝗱𝗧𝗲𝗰𝗵 𝗛𝗮𝗽𝗽𝗲𝗻.
🟡🟡🟠🟠🔴🟣
🎥 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.
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)
FDA Safety Communications and Recalls
Other FSCAs and Safety Notices
FSNs published by ANSM:
FSNs published in the UK: Field Safety Notices: 17 to 21 February 2025
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
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.
Europe Related
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)
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)
Global Items and General Industry News
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