Regulation

Post-Market Surveillance: The Rock On Which UK’s Global Regulation Ambitions Will Be Built

 
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The MHRA’s post-market surveillance regulations for Great Britain will be followed in 2026 by a pre-market regulation, but its progress will not be steered by the agency’s erstwhile leader of device system transformation. The ABHI’s Steve Lee and Phil Brown ponder where national device system regulation – and the MHRA – go next.

EU Clarifies AI System Definition, Including Specific Medical Technologies

 

The new definition of what is considered an ‘AI system’ in the context of the EU’s AI Act is helpful, but there is no automatic determination for medtech, and gray areas persist.

Sponsors Can Now Apply For EU’s Time-Saving Clinical Investigations Pilot

 

The European Commission has launched a pilot to deliver on its promise that member states should coordinate with each other on clinical assessment reviews under the Medical Device and IVD Regulations.

FDA Tissue Biopsy Draft Guidance Could Boost Liquid Biopsy Adoption In Clinical Trials

 

The US Food and Drug Administration (FDA) draft guidance limits tissue biopsy collection in clinical trials to primary endpoints and specific research use cases. However, Andrew Newland, CEO of circulating tumor cell (CTC) liquid biopsy firm Angle Plc, believes that the guidance could enhance the market for liquid biopsy makers.


Legal Overview Of MDR’s ‘Overly Broad And Vague Article 10a’

 

Measures for reporting interruption of supply or discontinuation of devices in Europe were rushed into the Medical Device Regulation, a German law firm claims, leading to the need for a stricter interpretation.

Modified Dermatology App Now Escapes Ban As German Court Cases Continue

 

The Dermanostic app is in the spotlight again as its recent action has prompted a German regional court to believe it no longer falls foul of a ruling recently made by a higher regional court.

Double Check Smartphone-Compatible Diabetes Devices, Advises FDA

 

The US FDA says diabetes patients who rely on their smartphones to receive critical disease-related alerts should ensure their phones are configured correctly. If not, the alerts might be missed.

FDA: Thawing Communications Freeze, But Advisory Panel Postponed

 
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Agencies within the US Department of Health and Human Services are beginning to communicate with the public again as HHS lifts the pause for some types of notices. However, other delays persist.


Withdraw AI Liability Proposal, Medtech Industry Tells EU Policymakers

 

Industry is quoting the Draghi report on EU competitiveness and its call for a clear, agile and streamlined legal framework in an attempt to get the EU to prevent overkill in the regulation of AI.

German IVD Industry’s Election 2025 Priorities: IVDR Reform, POC Push And Better Reimbursement

 
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Cardiovascular detection and pharmacy legislation were put on hold last November when Germany's federal election was called. Martin Walger, chief executive of the IVDs industry association, the VDGH, discusses the hopes and fears of IVD companies in the run-up to the February 2025 vote.

AI-Powered Patient Alert System Can Save Time, And Lives

 

An innovative patient monitoring system developed by Danish physicians sends vital signs data directly to nurses, allowing them to keep tabs on patients without being in the room.

UK Expects Digital Healthcare And AI Boost From New Centers Of Regulatory Excellence   

 

Seven new Centers of Excellence for Regulatory Science and Innovation have been funded by the UK with a brief to investigate smart regulation of AI and digital health innovations, among other areas. Medtech Insight asked Alastair Denniston, leader of the CERSI in AI and Digital Health Technologies, to explain the significance and the goals of his center.


EU AI Act Deadlines Loom: Are Medtech Companies At Risk Of Non-Compliance?

 

While the main deadline for the application of the EU’s AI Act to most AI-enabled medical technologies already regulated under the medtech regulations is 2 August 2027, various more immediate deadlines also need meeting.

Acting Commish Brenner May Bring IT Focus

 

Sara Brenner has been a key figure in the FDA’s diagnostics team, but her choice as acting FDA commissioner likely has more to do with her background with advanced technology and comfort level with the tech-focused side of the Trump transition team.

February Return To Office Planned For US FDA Senior Staff, With Schedule F Reclassification On Horizon

 

New details are emerging about how the administration will implement some of President Trump’s workforce shift back to mostly in-office work.

Why Notified Bodies Should Answer To A Centralized Regulatory Authority

 

Good is not always good enough. A centralized oversight body could help EU medtech testing bodies reach their full potential and ensure consistent regulatory balance says life sciences expert lawyer, Alison Dennis.


Are Downed DEI Pages Part Of Trump Executive Order Sweep, Or Just The Result Of Routine Transition?

 

Several pages on the US FDA website related to diversity and inclusion are down, which aligns with Trump’s recent executive order on diversity, equity, and inclusion. However, the Department of Health says there's been a “short pause” in communications to allow the incoming team to get in place.

Opinion: More FDA Predictions! (Gift Receipt Not Included)

 
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What's coming in 2025? Commissioner Makary, more digital health, and no movement on LDT regulation, predicts consultant and former FDAer Steve Silverman. See his reflections on the year ahead, as well as what he got right -- and wrong -- for 2024, here.

A Mission To Simplify EU And UK Medtech Regulation

 
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LFH Regulatory managing director and founder Laura Friedl-Hirst tells Medtech Insight what was piquing the interest of medtech companies visiting her company’s stand at Medica 2024.

European Health Data Space Due To Launch In Mid-March

 

New data-sharing framework signals a new era for health data exchange as EU initiatives to maximize its benefits kick into action.