EU IVDR Training
Practical European In Vitro Diagnostic Regulation Training
Patient Guard’s EU IVDR Training course provides a practical introduction to the requirements of the European In Vitro Diagnostic Medical Devices Regulation (EU IVDR 2017/746) and how organisations can achieve and maintain compliance.
This course is designed to help IVD manufacturers, regulatory professionals and quality teams understand the increased regulatory expectations introduced under the IVDR framework.
Our training combines regulatory guidance with practical industry knowledge to support organisations navigating the evolving IVD regulatory landscape.
Course Overview
The EU IVDR introduced major regulatory changes for in vitro diagnostic medical devices, including stricter classification rules, increased Notified Body involvement, enhanced performance evaluation requirements and stronger post-market surveillance obligations.
This training course addresses practical implementation strategy and modern regulatory expectations to support organisations developing and placing IVD devices successfully on the European market.
- IVDR structure and scope
- IVD classification requirements
- Performance evaluation expectations
- Technical documentation requirements
- PMS and vigilance obligations
- Economic operator responsibilities
- Quality management system expectations
- UDI and traceability requirements
Who Should Attend?
This specialized course is suitable for:
- IVD manufacturers
- Regulatory affairs professionals
- Quality professionals
- Product development teams
- Start-up companies
- Importers and distributors
- Authorised Representatives
- Individuals new to EU IVDR requirements
What You Will Learn
By the end of this course, participants will understand:
- The structure and purpose of EU IVDR 2017/746
- Key regulatory transitions and changes introduced under IVDR
- Bespoke IVD classification rules and frameworks
- Scientific and performance evaluation requirements
- Technical documentation file expectations
- PMS and vigilance timeline obligations
- Responsibilities of key corporate economic operators
- UDI frameworks and active EUDAMED concepts
- Relationships between IVDR and ISO 13485 QMS
- Common regulatory bottlenecks for IVD manufacturers
Course Topics
Introduction to EU IVDR
- Overview of EU IVDR 2017/746
- Scope and market applicability
- Transition milestones & requirements
IVD Classification
- Classification rules under Annex VIII
- Risk tiers: Classes A, B, C and D
- Impact on conformity assessment routes
Economic Operators
- Manufacturer operational responsibilities
- Authorised Representatives
- Importers and distributors
- Person Responsible for Regulatory Compliance (PRRC)
General Safety & Performance Requirements (GSPR)
- Annex I technical compliance
- Demonstrating conformity matrix options
- Harmonised standards and common specifications
Technical Documentation
- Annex II and Annex III requirements
- Technical file compliance reviews
- Documentation layout structure
Performance Evaluation
- Scientific validity thresholds
- Analytical performance reviews
- Clinical performance indicators
- Performance Evaluation Report (PER) creation
Post-Market Surveillance & Vigilance
- Modern PMS system construction
- Vigilance reporting thresholds
- Trend reporting metrics
- PMS plans, reports, and PSUR requirements
UDI & EUDAMED
- UDI generation and mapping rules
- Device listing registration protocols
- EUDAMED functional module overview
Quality Management Systems
- Relationship and integration with ISO 13485
- Risk management system alignment
- Internal regulatory procedures and controls
Course Pricing
Full-Day EU IVDR Training
- Live online instructor-led training access
- Comprehensive course training syllabi & materials
- Practical regulatory examples & clinical documentation scenarios
- Interactive Q&A access with the IVD training consultant
- Official Certificate of Attendance
Corporate & Private Team Training
Patient Guard provides customized private EU IVDR training blocks for operations seeking targeted regulatory integration and technical asset development support.
- IVD medical asset manufacturers
- Regulatory affairs & corporate quality teams
- Start-up enterprises and healthcare innovators
- Importers, logistics entities, and distributors
- Organisations migrating tech portfolios to secure IVDR conformity
- Total head count of operational attendees
- Overall scope and inclusion of specialized topics
- Underlying IVD assay tech profiles & product categories
- Preferred digital or corporate delivery paths
Logistics & Global Delivery
- Delivered natively via interactive, live streaming infrastructure
- Fully hands-on practical framework structures
- Accessible across all global territories and commercial time zones
- Dedicated corporate sessions available upon technical request
Group Booking Discounts
If you are reserving workshop space for multiple delegates from the same corporate operating facility, volume discounts may be applied.
Please contact Patient Guard directly to process specific tier group booking rates.
Request Course Pricing & Availability
Reach out to our diagnostic regulatory consulting team to schedule block workshop dates, manage group spaces, or receive an explicit customized team assessment quote.
Contact Patient Guard.
Why Choose Patient Guard?
FAQs
Is this course suitable for beginners?
Yes. The course is suitable for both beginners and professionals involved in IVD regulatory compliance.
Does the course include practical examples?
Yes. The training includes practical regulatory examples and implementation guidance.
Is the course focused on EU IVDR only?
Yes. This course focuses specifically on the European In Vitro Diagnostic Medical Devices Regulation (EU IVDR 2017/746).
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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