EU MDR Training
Practical European Medical Device Regulation Training
Our training combines regulatory guidance with practical industry knowledge to support businesses navigating the complexities of EU medical device compliance.
Course Overview
The EU MDR introduced significant changes to the regulation of medical devices within the European Union, increasing expectations around clinical evidence, technical documentation, post-market surveillance and quality management systems.
This training course focuses on practical implementation pathways and regulatory expectations to help organisations strengthen compliance metrics and support successful cross-border market access.
- MDR structure and scope
- Device classification
- Economic operator responsibilities
- General Safety and Performance Requirements (GSPR)
- Technical documentation requirements
- Clinical evaluation expectations
- Post-market surveillance obligations
- UDI and traceability
- Vigilance and reporting requirements
Who Should Attend?
This training module is suitable for:
- Medical device manufacturers
- Regulatory affairs professionals
- QA professionals
- Start-up companies
- Importers and distributors
- Product development teams
- Economic operators
- Individuals new to EU MDR requirements
What You Will Learn
By the end of this course, participants will understand:
- The structure and purpose of EU MDR 2017/745
- Key structural changes introduced under the MDR
- Device classification rules and frameworks
- Responsibilities of manufacturers and economic operators
- Requirements for technical documentation files
- Clinical evaluation methodologies and expectations
- PMS and vigilance reporting obligations
- UDI and EUDAMED registration concepts
- Strategic relationships between MDR and ISO 13485
- Common regulatory bottlenecks faced by manufacturers
Course Topics
Introduction to EU MDR
- Overview of EU MDR 2017/745
- Scope and applicability
- Transition timelines and requirements
Device Classification
- MDR classification rules
- Examples of device classifications
- Impact on conformity assessment routes
Economic Operators
- Manufacturer regulatory obligations
- Authorised Representatives
- Importers and distributors
- Person Responsible for Regulatory Compliance (PRRC)
General Safety & Performance Requirements (GSPR)
- Annex I structural breakdown
- Demonstrating conformity indicators
- Harmonised standards and common specifications
Technical Documentation
- Annex II and Annex III details
- Technical file compilation structure
- Regulatory documentation audit expectations
Clinical Evaluation
- Clinical evidence thresholds
- MEDDEV vs MDR expectations
- PMCF planning and reporting overview
Post-Market Surveillance & Vigilance
- Integrated PMS systems
- Vigilance timeline reporting
- Trend reporting analysis
- PSUR and PMS reporting obligations
UDI & Traceability
- Core UDI assignment requirements
- Device registration protocols
- EUDAMED functional module overview
Quality Management Systems
- Direct relationship with ISO 13485
- Risk management systems integration
- Regulatory compliance procedures and controls
Course Pricing
Full-Day EU MDR Training
- Live online instructor-led training
- Comprehensive course training materials
- Practical real-world regulatory audit examples
- Interactive Q&A access with the training consultant
- Official Certificate of Attendance
Corporate & Private Team Training
Patient Guard provides bespoke private team training sessions tailored specifically to your exact medical device technology pipeline, distribution classification, and internal corporate goals.
- Medical device manufacturers
- Regulatory compliance & quality assurance teams
- Strategic start-up companies & innovators
- Importers, economic operators, and distributors
- Organisations transitioning historical profiles to full MDR compliance
- Total number of operational attendees
- Specific scope lengths and deep-dive modules
- Underlying product risk profiles & technologies
- Preferred digital or structural delivery formats
Logistics & Global Delivery
- Delivered via live instructor-led streaming networks
- Fully interactive and practical working frameworks
- Available across international territories and time zones
- Dedicated bespoke enterprise blocks available upon request
Group Booking Discounts
If you are enrolling multiple delegates from a single operating facility or legal entity, tiered pricing discounts may apply.
Please contact Patient Guard directly to process custom volume booking requests.
Request Course Pricing & Availability
Reach out to our regulatory consulting team to schedule block training dates, secure group bookings, or request an explicit customized quote for your team requirements.
Contact Patient Guard.
Why Choose Patient Guard?
- Practical industry-focused training
- Experienced medical device regulatory professionals
- Training aligned with current EU MDR expectations
- Real-world regulatory examples
- Support for manufacturers and start-ups
- UK and EU regulatory expertise
FAQs
Is this course suitable for beginners?
Yes. The course is suitable for both beginners and professionals involved in medical device regulatory compliance.
Does the course include practical examples?
Yes. The training includes practical regulatory examples and implementation guidance.
Is the course focused on EU MDR only?
Yes. This course focuses specifically on the European Medical Device Regulation (EU MDR 2017/745).
Can training be customised for our company?
Yes. Patient Guard can provide tailored private training sessions aligned with your products and regulatory needs.
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