Course Outline

Course Information

• The course begins at the time stated below
• The course is broken up into modules outlined below
• There will be breaks between modules

30 September & 1 October 2026

7-Hour Course Delivered Over 2-Days

Register at the top of the page.

***The course outline will change/evolve with the regulations as they continue to be scrutinised, finalised and then implemented***

Session 1 | Day 1

210 mins | 1:00 PM UK

The “New” EU MDR/IVDR

Examining the 2026 European Commission overhaul intended to reduce administrative burden and prevent device shortages.

• The Return of Equivalence: Understanding the 2026 “flexibility” updates that allow manufacturers of Class IIb and III devices to utilise clinical data from similar devices without full contractual access to competitor files.
• Streamlined Recertification: Potential move away from fixed five-year certificate validity toward more flexible, risk-based certificate duration models.
• EUDAMED Mandatory Milestones: Compliance with the May 2026 deadlines for device registration and economic operator Single Registration Numbers (SRN).
• Interplay with the EU AI Act: Managing high-risk AI medical devices under the dual burden of MDR and the now-active AI Act requirements.
• Innovation and breakthrough technologies – support for early scientific advice, EU-level regulatory sandboxes and faster routes for innovative, orphan and paediatric devices.
• PRRC simplification
• Why?
  • Device Shortage Mitigation
  • Notified Body Capacity

The 2026 UK Medical Devices Regulations

A deep dive into the draft Statutory Instrument (SI) published in May 2026 and its impact on Great Britain (GB).

• The International Reliance Pathway (IRP): How to leverage approvals from the FDA (USA), TGA (Australia), and other trusted regulators to bypass traditional UKCA bottlenecks.
• Status and review of CE mark acceptance
• The 2026 Fee Structure: Navigating the new £300 annual maintenance fee per device and the financial implications of the April 2026 MHRA fee amendment.

Session 2 | Day 2

210 mins | 1:00 PM UK

Specialised Software & Innovative Pathways

Focusing on the 2026 updates for SaMD (Software as a Medical Device) and AI.

• Pre-determined Change Control Plans (PCCP): Using the new 2026 UK framework to implement software updates and AI model iterations without full re-certification.
• Cybersecurity & Data Privacy: Aligning UK and EU technical documentation to meet the 2026 harmonized standards for device resilience.
• The Innovative Licensing and Access Pathway (ILAP): How the 2026 “refreshed” ILAP reduces the time-to-market for transformative medical technologies.

Post-Market Surveillance & Vigilance

Practical implementation of the PMS Statutory Instruments.

• Strict Reporting Timelines: Mastering the new UK requirements for reporting serious incidents (including the shortened 10-day window for specific events).
• Periodic Safety Update Reports (PSUR): Differences in granularity between the EU’s EUDAMED submissions and the UK’s MHRA reporting portals.
• Custom-Made Device Traceability: New 2026 technical file requirements and electronic prescription mandates for bespoke devices (e.g., dental and orthopedic).

Strategic Planning & Gap Analysis

Closing session on business continuity.

• Scenario planning for 2026–2027 implementation
• What to do now while the proposal is not yet law
• Notified Body Capacity: Strategies for handling the 2026 bottleneck as IVDR Class C transition deadlines expire.

Richard Young has over 25 years’ experience in the medical device and IVD industry with products such as class 3 implants to electromedical infusion systems. Richard has extensive experience in regulatory affairs, GMP (quality), GLP (laboratory testing) and clinical affairs. Richard has held various positions within industry such as QA/RA Manager and Director, Quality Assurance and Regulatory Compliance at various companies including Biomet, Plasma Surgical and Zimmer Limited.

Richard has been an independent consultant for over 6 years, supporting companies with regulatory and quality advice on a range of different products. He has extensive experience of European regulations including the MDD, IVDD and more recently the MDR and IVDR. In addition, Richard understands the US FDA requirements for devices and diagnostics. He also has a comprehensive working knowledge of device ISO standards such as 13485 and 14971.