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…
The International Medical Device Regulators Forum (IMDRF) has released a draft technical document, titled ‘Technical Framework for Artificial Intelligence Life Cycle Management’, to propose a harmonized set of best practices in mitigating risks associated with the use of artificial intelligence (AI)-enabled medical devices throughout their product life cycle. The guidance states that “the GMLP principles…
ISO 14155 addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices. The new edition ISO 14155:2026 has been made available by ISO in English, French, and with redlines showing the changes from the…
The UK MHRA has today published its promised public consultation on indefinite recognition of CE marked medical devices for the Great Britain (GB) (England, Scotland, and Wales) market (Northern Ireland already accepts CE marked devices). The consultation invites views on the following proposals: Extending the current transitional arrangements for devices that comply with the Medical…
