Regulation

The director of the US FDA’s device center is sounding the alarm on the scarcity of critical devices for pediatric patients and says the agency is focused on solutions to this “unique” challenge.

Member states reported 309 significant cybersecurity incidents affecting the healthcare sector in 2023 – more than in any other critical sector.

The long-awaited post market surveillance regulation for medical devices on the Great Britain market will come into force on 16 June.

The European Commission has issued a report on the protectionist medtech policies in China that are impacting imports and is considering measures to protect EU manufacturers.

The US FDA final guidance uses a Q&A format to help manufacturers navigate the regulatory landscape for communicating the off-label uses of their medical products to health care professionals. However, some say the final document fails to address potential free speech concerns.

Five EU documents will serve to rapidly address calls for urgent changes to the Medical Device Regulation.

Switzerland’s devices MRA with the EU is fully back on the agenda following a broader, historic EU-Swiss future trade deal agreed on 20 December. Additionally, Swiss Medtech is pursuing MDR improvements with EU counterparts, and the Swiss authorities will lay the ground in 2025 to permit US FDA-approved in Switzerland.

Only a week ago, the European Commission launched a consultation to which medtech stakeholders were invited to reply. Now it has launched a survey. Why two separate calls in one month and how will that information be used?

Following the Council of the EU’s early December meeting, a strong consensus is emerging among industry and policymakers on the nature of many aspects of the much-needed reform of the EU’s medtech regulations.

UK MHRA updates timings for key elements of the new system of medtech regulation in Great Britain and prepares to assess IVD sector views.

With debate intensifying in the EU over potential EMA oversight of device regulation, life sciences lawyer, Alison Dennis, is advocating for a distinct European Devices Agency to streamline and improve current regulations.

There is considerable pressure now on the European Commission to complete its targeted evaluation of the EU’s medical device regulations and start rectifying many of its shortfalls that are impacting patients and industry alike

The US FDA has issued its first communication as part of a new pilot program the agency initiated to increase transparency in recalls of high-risk medical devices. The early alerts are meant to minimize the time between the FDA finding out about a potential issue and informing stakeholders.

Centralized regulation will be beneficial for classification and borderline decisions, orphan device decisions, and recertifying notified bodies. But it is not a panacea for EU medtech in the view of Sabina Hoekstra-van den Bosch.

Keep an eye on next year’s over-the-counter drug user fee negotiations for insights into the incoming Republican administration's approach to device regulation, attorneys said in a recent webinar. Other areas to watch include AI and diagnostics regulation, with potential bipartisan agreement on AI oversight

During an online seminar Tuesday, the FDA offered guidance on registration and listing requirements for lab-developed tests that will go into effect on 6 May 2026.

Incoming EU health commissioner gets to grips with need for MDR review and faces demands from council ministers for centralized elements in EU devices legislation.

The agency also will not expand the guidance categories that may be issued “for immediate implementation” without prior public comment, but more guidance documents could be issued in Q&A or bulleted formats, the agency said.

We do not want the commission to wait for its targeted evaluation before making regulatory changes to the MDR and IVDR, medtech industry representatives tell Galway meeting. They shared their vision of what could happen next.

How a medical doctor with software development interests who is pursuing a career in medtech consultancy claims to have exposed a huge overspend on the EU’s medical device database. But is he comparing like for like?