EU Medical Device Regulation
Seven calls for proposals totaling €63.2m offer a glimpse into the EU’s priorities for AI and digital health.
The EU’s Digital Omnibus legislation delegates some AI medtech regulation to MDR – a role it is not necessarily built for.
The EU’s Digital Omnibus has made some of medtech’s requested changes to the AI Act; now the sector hopes the same can happen with the Data Act.
An open letter says recent EU AI Act amendments create “loopholes” that leave some elements of AI-enabled medical devices under-regulated.
Technical regulations for AI medical devices may not survive contact with humans. A research team from the Dresden University of Technology investigates how regulators and manufactures can account for human error in AI device deployment.
A new report from the Wound Care Sector Working Group sounds the alarm: chronic wound care is rapidly becoming a growing burden. The EU must act now to make care coordination, reimbursement and innovation strategic priorities.
Industry association MedTech Europe has welcomed amendments to the AI Act that delay and simplify rules for AI medical devices, but more work still needs to be done on clarity, coherence and system implementation.
Two lawyers within EU legal chamber Axon Lawyers created a Green Team to cope with the rise in EU Green Deal and related environmental sustainability and compliance needs for medtechs. One of them, Jilles van der Hoek, explains why manufacturers should be getting a jump on future requirements.
In an effort to streamline AI rules for high-risk systems and improve competitiveness, two European Parliament committees agreed amendments to the EU AI Act that will allow medtech companies to avoid double certification with notified bodies. A plenary vote takes place in late March.
Regulatory uncertainty has affected business planning and funding opportunities for UK medtech companies, says Gerard Hanratty, head of health and life sciences at UK and Ireland law firm Browne Jacobson. On the other hand, the UK industry should not squander the opportunities it uniquely faces.
Petra Zoellner, regulatory affairs director at MedTech Europe, provides an update on the pace and direction of travel of recent European Commission proposals and actions for the EU medtech sector, while emphasizing the need for speed.
The UK MHRA issued its targeted consultation on the indefinite recognition of CE marked devices in Great Britain on Feb. 16.
With EU MDR/IVDR review proposals out, UK MHRA progress on a premarket regulation and, up ahead, a prospective consultation on accepting the CE marking indefinitely, now is a good time to assess EU-UK regulatory positions for the benefit of UK industry, says ABHI director Steve Lee.
If medtech regulation is to work for patients, industry and society, Europe must move from political positioning to evidence-driven policymaking. It is time to avoid repeating the self-destructive cycle.
AI promises to be the much-needed solution to the now overly complex field of EU medtech regulatory affairs. Will every stakeholder start using solutions such as Raiana?
The European Commission’s proposal does not envisage a single centralized medtech agency, but instead sets out a targeted redistribution of tasks that could strengthen the existing framework. Professor Tom Melvin told Medtech Insight how.
Could the understaffing that has weighted down EU’s medtech regulators become a thing of the past?
European Commission-sponsored study published in December reveals the full impact of soaring compliance costs, shrinking device portfolios and innovation shifting abroad.
The UK MHRA will soon consult on allowing CE-marked devices indefinite access to the Great Britain market. Meanwhile, the EU has at last moved to make the MDR/IVDR more user friendly. Taylor Wessing partner Alison Dennis reflects on how these events could influence evolving UK medtech legislation.
Proposal Gives Unrealistic Timelines And Reflects Poor Grasp Of Notified Body Realities