The Australian start-up company Tournicare Pty Ltd has achieved US marketing clearance from the Food and Drug Administration (FDA) for its ARMA over-the-counter Blood Pressure Monitor (BPM) via the 510(k) pre-market notification process with regulatory assistance from Donawa Lifescience. Tournicare announced its success in a LinkedIn post in mid-June. Tournicare CEO Niels van Sparrentak explains:…
The US Food and Drug Administration (FDA) has finalised its guidance titled ‘Content of Human Factors Information in Medical Device Marketing Submissions: Guidance for Industry and Food and Drug Administration Staff,’ superseding the draft released in December 2022. The guidance provides a risk-based framework to guide manufacturers and FDA staff on the human factors information…
28 May 2026 marks a major milestone for the European medical devices’ regulatory framework, as four modules of EUDAMED are now mandatory to use, these being: – Actors – UDI/Devices – Notified Bodies & Certificates – Market Surveillance The long overdue use of EUDAMED is intended to enhance transparency, traceability, and regulatory cooperation across the…
MedTech Europe, the European industry association for the medical technology industry, has published its views on the political agreement reached on amendments to the EU AI Act, commenting that it “is not the outcome MedTech Europe sought.” The AI Act creates a legal framework to encourage the development of “human-centric and trustworthy” artificial intelligence for…
MedTech Europe, the European industry association for the medical technology industry, has published its views on the European Commission’s (EC’s) proposals for revision to the Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR). The position paper recognises that the EU’s regulatory framework for medical technologies is at a pivotal moment, with significant problems…
Continuing the UK Medicines and Healthcare products Regulatory Agency’s (MHRA’s) regulatory reform work, the Agency has now published details of the draft premarket statutory instrument, ‘The Medical Devices (Amendment) Regulations 2026’, as submitted to the WTO, alongside a supporting stakeholder survey. The draft legislation introduces updated premarket requirements for medical devices and IVDs placed on…
The US Food and Drug Administration (FDA) has announced that it is piloting one-day inspectional assessments, as part of a broader initiative to make its inspection resources more targeted and efficient. As part of this pilot, which launched in April, the agency is conducting shorter, focused screening assessments to complement standard FDA inspections. “One-day inspections…
On Friday 24 April 2026, the European Medicines Agency (EMA) hosted a two-hour information session on its new Breakthrough Medical Device Pilot. Four days later, on April 28, the pilot opened. The purpose of the pilot is to test a new regulatory pathway that supports patient access to highly innovative technologies, while maintaining the EU’s…
Among recent updates available from the European Commission are the following: Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices, Version 5 dated April 2026 MDCG 2021-24 Rev.1, Guidance on classification of medical devices Manufacturer Incident Report MIR PDF…
The central medical device database, EUDAMED – a key EU medical device regulatory infrastructure – will become mandatory from 28 May 2026. Preparing for EUDAMED readiness requires a cross-functional transformation, involving teams across regulatory affairs, quality, R&D, labelling, product data management and commercial functions. To support senior business leaders in understanding the strategic implications, MedTech…
