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EU IVDR Training

Practical European In Vitro Diagnostic Regulation Training

Our training combines regulatory guidance with practical industry knowledge to support organisations navigating the evolving IVD regulatory landscape.

500+ Manufacturers Supported

BSI ISO 13485 Certified

UK & EU Offices

Former MHRA Expertise

Established 2017

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.

Core elements covered include:

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 Format & Delivery

Live online instructor-led training
Private corporate company sessions
Group interactive workshops
Customised training programmes

Training tracks can be customized specifically around your internal technology pipeline and unique asset scope.

Course Duration

Typical delivery structures:

Full-Day: Main technical compliance syllabus

Extended workshops and bespoke tailored modules are available for operations requiring deep-dive technical support.

🏆 Certification: All participants receive an official Certificate of Attendance upon course completion.

Course Pricing

Individual Path

Full-Day EU IVDR Training

£695 / per person

What's included:

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.

Corporate Rate

From £2,500 / day

Ideal for:

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

Bespoke pricing parameters depend on:

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?

Practical industry-focused training
Experienced IVD regulatory professionals
Training aligned with current EU IVDR 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 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.

Munna P

51 days ago

Working with the Patient Guard team has been a great experience throughout our MHRA and ISO 13485 documentation journey. Their expertise, structured approach, and practical guidance helped our team build a robust quality management system while keeping us aligned with regulatory expectations. The collaboration was professional, responsive, and focused on finding solutions rather than simply identifying issues. A special thank you to Alex and Steve for their outstanding coordination, responsiveness, and continuous support throughout the project. They were always approachable, provided valuable feedback, and worked closely with our team to resolve challenges efficiently. Their commitment made a significant difference in keeping our documentation effort on track. I highly recommend Patient Guard to any healthcare or MedTech organization looking for experienced regulatory and quality system partners for MHRA, ISO 13485, and broader medical device compliance initiatives. Thank you again to the entire Patient Guard team for being such reliable partners.

Peter Reeve

78 days ago

STEPPER design, manufacture & distribute eyewear across the globe. With the increasingly complex landscape concerning the placing of Mecial Devices onto the market, we realised we needed professional guidance. We found Patient Guard via a simple internet search and are delighted we did! They provide a pragmatic solution to our needs, are totally reliable & always available to answer our (often simplistic) questions. They are highly efficient & responsive to what is a changing picture in our world and nothing is too much trouble. We have a much better understanding of regulatory affairs and our responsibilities as manufacturers & distributors and they support us in navigating the requirements in different territories. Updating our Declaration of Conformity, ensuring our labelling is compliant and acting as our PRRC are the key areas of their service for us.

Derek Timm

78 days ago

For those companıes lookıng to comply to ISO standards and ın partıcular ISO13485 whıch to be honest ıs a nıghtmare I would strongly suggest goıng to the professıonals as ındeed we dıd by joınıng forces wıth Patıent Guard Ltd The staff are fantastıc nothıng ıs too much trouble and as a medıcal supply company we sımply cannot lıve wıthout them Thanks ın partıcular to Alex and Steve for all the hard work and our best regards from Dan Medıca South Lımıted

BMSCriticalCare

115 days ago

Great service, very helpful and always willing to answer any questions we have,

Thomson Software

786 days ago

Alex Lewis of PatientGuard guided us through the ISO13485 process in a thorough, systematic and efficient manner. He was friendly, patient and willing to go the extra mile. Excellent service.

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