Medical Device Regulation Tracker

Start your gap analysis now - certified orgs must transition by 31 Oct 2028, with cert bodies ready from May 2026.

• Deadlines: Published 14 Oct...

April 2026 Standards Update on Assent Risk Management published, with tags #CD #DIS #FDIS #Standards. Consultants urge manufacturers to prepare early for changes and transition to new standards ahead of competitors.

• $4.8m secured by MHRA over three years to expand AI Airlock
• UK's regulatory sandbox for AIaMD gets major lift
• Key opportunity for developers: Test compliance faster, speed UK market access via expanded sandbox support

Legacy Class C IVDs can stay on the EU market until December 31, 2028 only if manufacturers take active steps toward IVDR certification – no action risks withdrawal.

EU and UK Authorised Representatives Guidance

• 🔥 GetReady Compliance Best Practices: Guidance explains EU Authorised Representative requirement...

Methodological gaps limit RWE in joint clinical assessments (JCA), with HTA Coordination Group guidance only for non-randomized direct inputs.

• Key...

• AI regulations forgetting human factor? MedTech Insight questions gaps in oversight
• MHRA aims to stay close to FDA and even closer to EU on regs
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Key compliance guidance for non-EU med device makers amid GB's CE acceptance:

• EU AR mandatory under Market Surveillance Reg (EU) 2019/1020: Verify...

MHRA-FDA Collaboration Boost

• 🔥 Tariffs Lifted and Ties Strengthened: US FDA and UK MHRA agree to bolster medical technology collaboration while...

Key strategies for manufacturers deploying devices in non-clinical settings:

• Self-monitoring & testing: Continuous readiness checks, usage tracking,...

Practical wins for UK manufacturers:

• Tariff relief: US lifts duties on UK pharma/medtech imports for 3+ years, cutting export costs
• Reciprocity...

MHRA Consultation Updates

• 🔥 Indefinite Recognition of CE-Marked Devices: MHRA has launched a consultation seeking views on proposed changes to...

• MHRA consultation launched on indefinite recognition of CE-marked medical devices.
• Seeking views on proposed changes.
• Key for manufacturers tracking UK compliance updates to shape GB strategy.

UK and US to deepen regulatory ties on medical devices – key development for UK manufacturers eyeing mutual recognition to streamline approvals and cut dual US-UK compliance costs.

New guidance targets manufacturers of Class II, III, and IV medical devices—and regulators—on clinical evidence requirements. Essential reading for compliance documentation.

AI/ML devices heighten human factors risks like over-reliance and transparency gaps, demanding creative usability approaches beyond conventional...

AI medical diagnostic devices (AIMDDs) use algorithms to analyze multi-source data—such as symptoms, vital signs, medical images, and lab results—to determine diagnoses.

• 90% of GB devices CE-marked; MHRA proposes indefinite recognition to avoid supply disruptions.
• Key options: Extend MDD transitions, align GB...

CE or CE+UKNI marked products can be placed on the Northern Ireland market. CE markings show manufacturers believe products meet relevant requirements across a range of products – vital for post-Brexit dual compliance strategies.

Medrais clarifies when a clinical investigation is mandated for medical devices, ensuring adequate evaluation of safety and performance. Key for early-stage compliance planning across device classes.