Regulation

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.

Renewal of the Swiss-EU Mutual Recognition Agreement for medical devices may still be a year or two away, but momentum towards ratification was maintained in March when Swiss and EU political leaders signed the final outstanding agreements of the Bilaterals III sectoral agreements.

A major vendor is suing Medicare over new reimbursement policies for skin cancer radiotherapy, which they claim could harm patient access to treatment. The policy applies the same reimbursement level to different equipment types, leading to industry disagreements about whether it’s fit for purpose.

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.

The US FDA has issued an early alert concerning Intuitive Surgical staplers used during various procedures with the da Vinci Surgical System. The company is instructing customers to stop using the devices.

IMDRF’s playbook on regulatory reliance was in the spotlight at the Forum’s 29th meeting this week, on the heels of its new midterm regulatory strategy document. 2026 IMDRF chair Singapore used the occasion to announce unprecedented WHO acclaim for the nation’s device regulatory oversight.

During MDUFA negotiations held Feb. 11, the medtech industry agreed to a proposal from the FDA to base its hiring commitments on MDUFA IV.

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.

CMS is asking stakeholders to help the agency craft potential regulatory changes aimed at bolstering its efforts to combat Medicare and Medicaid fraud. The agency has provided several topics to help guide stakeholder engagement.

CMS has reopened the TAVR coverage memo to consider coverage for without symptoms aortic stenosis and pure regurgitation. Stakeholders want to relax CED requirements and update NCD to include newer FDA-approved TAVR devices, improving patient access and outcomes in valvular heart disease treatment.

The Trump administration says a six-month moratorium on enrolling new suppliers of durable medical equipment is part of a wider strategy to combat healthcare fraud and abuse.

The US Supreme Court struck a blow to the Trump administration’s efforts to impose sweeping tariffs, ruling the president exceeded his authority. Limiting tariffs has been a priority for the medtech industry.

The US FDA says incorrect code messages from some Trividia glucose measurement devices could result in delayed treatment and serious patient harm.

The UK MHRA issued its targeted consultation on the indefinite recognition of CE marked devices in Great Britain on Feb. 16.

The US FDA has published an updated inspections manual detailing how it will conduct investigations going forward under its new regulatory framework. Medtech Insight talked to a couple of regulatory experts about the key changes to the new protocol.

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.

The US FDA has published its annual international harmonization assessment for fiscal 2025, which reports on the device center’s progress in aligning medical device regulations with global standards to improve patient access to safe, innovative technologies.

The US FDA’s Quality Management System Regulation has officially replaced the decades-old Quality Management System. The new system links with international standards for regulating medical device systems.