A More Competitive MedTech Landscape in the EU? What the MDR/IVDR Revision Could Mean for MedTech Manufacturers and Investors
The EU’s targeted revision of the medical device and in vitro diagnostics framework has entered a more active phase, with nearly 800 amendments tabled in Parliament in July 2026 and the Council’s examination continuing in parallel. The revision would ease certification bottlenecks by removing the five-year cap on certificate validity, scaling notified body involvement to device risk, and letting lower-risk software move down to self-certified Class I. It would also loosen clinical evidence requirements, create fast-track pathways for orphan and breakthrough devices, and regulate AI-enabled devices primarily under the MDR/IVDR rather than the AI Act. This post summarizes the key aspects of the proposed revision, the prospects for their adoption, the issues still in play, and what manufacturers and investors should plan for.
UK Looks To Modernize Medicines And Medical Device Regulation In The Era Of AI
A landmark program designed to deepen the regulatory partnership between the UK and the U.S., a regulatory ‘sandbox’ for AI as a medical device, evidence-gathering on AI regulation in healthcare, a consultation on a draft Rare Disease Therapies Regulatory Framework and the launch of the largest package of UK clinical trial reforms in over 20 years – Sidley’s Dr. Chris Boyle and Zina Chatzidimitriadou bring you up to date with developments at the UK Medicines and Healthcare products Regulatory Agency (MHRA) in the first half of 2026.
The EU AI Act’s Machinery Exemption: Does It Extend to Surgical Robotics?
The EU’s latest AI reforms are intended to reduce regulatory duplication for products already subject to extensive sector-specific regulation. For manufacturers of surgical robotics, however, they leave unresolved how AI embedded within increasingly sophisticated surgical systems will be regulated in practice.
Medicines and Healthcare Products Regulatory Agency: The Road to Medical Device Reform
The Medicines and Healthcare Products Regulatory Agency (MHRA) has recently published three policy developments as part of its overhaul of medical device regulation in the UK. The AI Airlock, announcement of international recognition procedure for medical devices, and consultation on technical specifications for the In Vitro Diagnostics Regulation (IVDR) signal the MHRA’s continued focus on reform and international alignment in this area. Industry stakeholders should take note and engage with the regulator where possible to have their voices heard as part of the process.
