Regulatory Affairs

2026 Is One of the Most Significant Years in Global Medical Device Regulation. Is Your Device Ready?

EUDAMED mandatory from 28 May 2026. FDA QMSR Final Rule effective February 2026. MHRA International Reliance routes arriving. ANVISA UDI Class II deadline passed. CVX Corven MedTech actively tracks every major regulatory market — so your submission strategy is always built on what regulators require today, not yesterday.

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⚡ Live — September 2026
Our Regulatory Market Coverage
FDA
USA
EU MDR
Europe
UKCA
United Kingdom
EAEU
Eastern Europe
ANVISA
Brazil
Health Canada
Canada
PMDA
Japan
FDA Services EU MDR Services Global Regulations Who We Serve Book a Review

Regulatory Affairs & Global Compliance

End-to-end regulatory pathway planning and submission support for the US and European markets.

FDA Regulatory Affairs

Submission-Ready. Compliance-Built.

We provide strategic guidance and technical support for navigating the complex US regulatory landscape.

Key Deliverables:
  • FDA 510(k) & De Novo Submissions
  • Predicate Device Analysis
  • Substantial Equivalence Argumentation
  • Notified Body Liaison Support
CE Marking & EU MDR

EU MDR 2017/745 Compliance

Expert support for the European Union Medical Device Regulation, ensuring your device meets the highest safety standards.

Key Deliverables:
  • Regulatory Pathway Planning
  • Technical File & Documentation
  • IVDR Transition Support
  • Clinical Evaluation (CER/CEP)
  • Post-Market Surveillance (PMS)

Planning your first FDA, UKCA, CE, EU MDR, ANVISA or PMDA submission?

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Global Regulatory Coverage

The Regulatory Landscape Is Changing Faster Than at Any Point in a Decade. We Track It So You Don't Have To.

From critical 2026 EUDAMED deadlines to the FDA's new QMSR Final Rule and ANVISA's updated SaMD requirements — the global regulatory environment is shifting across every major market simultaneously. CVX Corven MedTech actively tracks every jurisdiction we operate in, ensuring your regulatory strategy is always built on the most current requirements.

⚡ Active Regulatory Deadlines Across 5 Markets — Current as of September 2026
US
FDA · USA
Active · Feb 2026
QMSR Final Rule — 21 CFR Part 820 Now Replaced by ISO 13485-Aligned Requirements
Effective February 2026, the FDA's Quality Management System Regulation replaces the previous 21 CFR Part 820 with requirements aligned to ISO 13485. All 510(k) and De Novo submissions must now reference the new QMSR framework. Additionally, updated Clinical Decision Support and SaMD guidance issued January 2026 expands the scope of digital health tools exempt from FDA oversight — critical for any company developing health software or wearables.
510(k) De Novo
EU
EU MDR · Europe
Deadline · 28 May 2026
EUDAMED Mandatory — New Device Registration Required Before EU Market Placement
From 28 May 2026, four EUDAMED modules become mandatory under Commission Decision (EU) 2025/2371: Actor Registration, UDI/Device, Notified Bodies & Certificates, and Market Surveillance. New MDR/IVDR devices must be registered in EUDAMED before first placement on the EU market. Legacy devices already on market must be registered by 28 November 2026. Separately, the EU MDR Simplification Package (COM 2025/1023) proposes a 30% reduction in administrative burden — legislative adoption expected late 2026 to early 2027.
EU MDR
GB
UKCA · MHRA · UK
2026 Update
New International Reliance Routes and IVD Framework — UK Regulatory Landscape Restructuring
The MHRA is introducing International Reliance routes in 2026/2027, allowing devices approved by the FDA, Health Canada, EU, and Australia to gain streamlined GB market access. CE-marked devices (EU MDR/IVDR compliant) remain accepted in Great Britain until 30 June 2030. New Post-Market Surveillance requirements effective June 2025 introduced tighter incident reporting timelines (15 days instead of 30) and mandatory PSURs for higher-risk devices. The MHRA's IVD Road Map (December 2025) outlines a new four-class IVD risk framework through mid-2027.
UKCA
BR
ANVISA · Brazil
Active · 2026
ANVISA UDI Implementation — Class II Deadline Passed, Class III/IV Ongoing
ANVISA's UDI programme for Class II medical devices passed its deadline in 2026. Class III and IV device UDI registration is ongoing with phased deadlines through 2027. Additionally, updated SaMD classification guidance aligned with IMDRF principles came into effect, requiring reassessment of digital health products currently marketed in Brazil.
ANVISA UDI
Our Regulatory Intelligence

We Don't Just Know These Regulations. We Work in Them Every Day.

The regulatory updates on this page are actively monitored and maintained by our team. Every CVX Corven MedTech engagement is built on the most current regulatory requirements — so your strategy is never based on guidance that no longer applies.

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Work With Us

Whether It's Your First Submission or Your Fifteenth — We Build It to Succeed.

Navigating FDA and EU regulations is a marathon, not a sprint. We provide the technical expertise and strategic foresight to get you across the finish line.

For Startups & Founders

Strategic Pathways for Rapid Market Entry

You need a regulatory strategy that protects your vision while respecting your runway. We help early-stage ventures build submission-ready frameworks from day one.

What We Do For You
  • Regulatory Roadmap & Hazard Analysis
  • Predicate Device & Equivalence Strategy
  • Lean QMS Implementation (ISO 13485)
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Pharma & Established MedTech

Global Expansion & Compliance Continuity

Ensure your global presence remains unshakable. We handle the heavy lifting of multi-market submissions and regulatory remediation for complex portfolios.

What We Do For You
  • Multi-Region FDA & EU MDR Submissions
  • Post-Market Surveillance & Clinical Support
  • Regulatory Audits & Remediation Plans
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Not sure where you fit? Our regulatory assessment helps you identify the fastest path to compliance for your specific device class.

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