EU MDR and IVDR Medical Device Compliance Corporate Training
Learn to navigate MDR and IVDR rules for medical devices and IVDs in live guided labs with regulatory practitioners.
Edstellar, a corporate training company, delivers corporate training that helps your team learn to manage EU MDR and IVDR compliance for medical devices and in vitro diagnostics. Employees develop skills in device classification, conformity assessment routes, technical documentation, quality management, clinical evaluation, and post-market vigilance through guided labs led by practitioners. Each session is tuned to your device portfolio, regulatory milestones, and workflows.
Instructor-led group trainingVirtual / on-site / off-site10 languagesDelivered inEnglish, Spanish, Mandarin, German, Arabic, Portuguese, Hindi, French, Japanese, Italian100+ countriesWe have delivered inUnited States, United Kingdom, India, Canada, Germany, France, Netherlands, UAE, Saudi Arabia, Singapore, Australia, Japan, Brazil, South Africa and 90+ more countries
How we build an MDR and IVDR ready team
EDSTELLAR MEDICAL DEVICE REGULATORY CAPABILITY MODEL
Assess regulatory readiness
Skill checks map your team's MDR and IVDR baseline across classification, documentation, and vigilance.
Standardize submission practice
One shared playbook for classification, technical documentation, and QMS evidence your teams reuse.
Practice in guided labs
Labs cover classification, dossier drafting, QMS mapping, clinical evaluation, and vigilance reporting.
Measure compliance lift
Lab reviews benchmark each employee's regulatory accuracy against MDR and IVDR expectations.
Scale across the portfolio
One standard rolls out across product families, device classes, and global regulatory teams.
Need more than one program?Get a group quote
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Program Overview: What is EU MDR and IVDR Medical Device Compliance?
EU MDR & IVDR Medical Device Compliance is Edstellar's instructor-led program for regulatory, quality, and clinical teams bringing devices to the EU market. Participants master MDR and IVDR foundations, device classification and conformity routes, technical documentation and dossier compilation, ISO 13485 QMS evidence, clinical and performance evaluation, and post-market surveillance with EUDAMED. The program is built for teams navigating the transition from the old directives.
Training works on the team's real devices. Participants classify their own products and select conformity routes, compile technical documentation sections against dossier requirements, and map clinical evaluation and PMS plans in guided labs. Instructors with notified-body and industry experience review every document, checking it against what reviewers actually reject. The program closes with a capstone: the MDR/IVDR transition compliance plan.
Transition timelines have caught many manufacturers out: under-classified devices, technical files that don't meet the new documentation bar, and clinical evidence planned too late. This program teaches your team to run the transition as a controlled program, with classification, documentation, and evidence sequenced against the deadlines. Every exercise targets a known rejection reason.
The capstone is a transition compliance plan for the team's device portfolio: classifications with conformity routes, documentation gaps with owners, clinical evaluation strategy, and a surveillance plan through EUDAMED. The team defends it against the questions a notified body would ask. They return with a plan that survives regulatory review.
Seven modules and 28 hours: MDR and IVDR foundations, classification, technical documentation, ISO 13485 QMS, clinical and performance evaluation, post-market surveillance and vigilance, and a capstone transition compliance plan. Every module pairs concepts with a guided lab, so each technique is practiced. It closes with a capstone plan your team presents and defends.
Delivery is hybrid across virtual and onsite sessions, scheduled around your calendar. Cohorts train as one group or split into batches, with session materials and lab guides included for every participant.
What's Included in this Workshop for Your Enterprise Teams
- 1
Classification and route selection labs
Classify sample devices and justify conformity routes.
- 2
Technical documentation drafting
Draft dossier sections with GSPR evidence mapping.
- 3
QMS evidence mapping
Link ISO 13485 records to submission requirements.
- 4
Evaluation and vigilance labs
Plan evaluations and practice incident reporting.
- 5
Capstone transition plan
Build and defend a portfolio compliance plan.
- Instructor-led delivery across virtual, onsite, and hybrid
- Guided labs in every module with instructor coaching
- Capstone transition plan, reviewed with your team
- Flexible scheduling around your calendar
- Lab guides and reusable dossier templates included
- Group size and batches set along with you
Build your team's skills. Anywhere in the world.
Real-world use cases
from day one
Instructor-led training
for your teams
Delivered globally
in 100+ countries
Enterprise Training Solutions Customized for Your Company
One partner for instructor-led corporate training, delivered the way your teams work.
Request a Training Quote- Customized Training Delivery
- Scale Your Training: Small to Large Teams
- In-person Onsite, Live Virtual or Hybrid Training Modes
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- Hands-On Labs on Live Infrastructure, Led by Industry Experts
EU MDR and IVDR Medical Device Compliance Course Topics and Program Outline
A tailored 28-hour, seven-module program: one learning journey from MDR and IVDR foundations to a capstone transition compliance plan. Sessions pair concepts with hands-on labs on real-world use cases. Materials include lab guides and dossier templates, plus a capstone assessment.
Built by Edstellar with medical device regulatory specialists
Built by regulatory affairs practitioners who steer devices and IVDs through MDR and IVDR submissions, shaped around your device portfolio and regulatory milestones.
Skill checks baseline your team's regulatory knowledge across MDR and IVDR topics before training begins.
Live instruction covers MDR and IVDR foundations and classification across 7 focused hours of content.
Guided labs build dossier drafting, QMS mapping, and evaluation skills across 12 hours of supervised practice.
Your team runs vigilance workflows and ships a capstone transition plan in 9 hours, reviewed by the instructor.
From MDR and IVDR foundations to a capstone transition plan, every skill is practiced in guided labs.
Delivered as
Delivered as a hybrid program of live instruction and guided labs, scheduled around your team's calendar in flexible batches.
Navigate the MDR and IVDR article structure on a sample device index, then plot transition deadlines for a mock product list in a guided walkthrough.
learna)Regulatory scope and key definitions
b)MDR 2017/745 and IVDR 2017/746 structure
c)Notified bodies and their roles
d)EUDAMED actors and modules
e)Transition timelines and legacy devices
Classify a set of sample devices under MDR and IVDR rules, then select and justify the conformity assessment route for each in a guided exercise.
learna)MDR classification rules and risk classes Ia to III
b)IVDR classification rules and risk classes A to D
c)Borderline products and qualification criteria
d)Conformity assessment routes and annex choices
e)Notified body selection and engagement
Draft the device description and intended purpose sections of a sample dossier, then complete a GSPR evidence checklist against it.
practicea)Device description and intended purpose
b)GSPR checklist mapping and evidence
c)STED format and dossier structure
d)Labelling requirements and UDI assignment
e)Reviewing notified body deficiency patterns
Map a sample QMS procedure set to MDR technical documentation requirements, then draft a CAPA record from a mock audit finding.
practicea)ISO 13485 structure and regulatory alignment
b)Design controls and design history files
c)CAPA process and effectiveness checks
d)Document control and record retention
e)Mapping QMS evidence to submissions
Draft a clinical evaluation plan outline for a sample device and a PMCF activity list, reviewed against notified body expectations.
practicea)Clinical evaluation plans and reports
b)Literature search and appraisal methods
c)Equivalence and state of the art analysis
d)Post-market clinical follow-up planning
e)IVDR performance evaluation: scientific validity, analytical and clinical performance
Classify sample incidents against vigilance reporting criteria, then draft a mock regulator notification and FSCA plan.
applya)PMS plans and periodic safety update reports
b)Vigilance reporting timelines and criteria
c)Field safety corrective action workflow
d)Incident classification and documentation
e)EUDAMED vigilance and UDI workflows
Build and present a complete MDR/IVDR transition compliance plan for a mock device portfolio, defended in an instructor review.
applya)Portfolio gap assessment methodology
b)Remediation prioritization by risk and deadline
c)Notified body readiness package
d)Transition plan structure and governance
e)Presenting findings to regulatory stakeholders
Customize this program tailored to your team?
Tell us your training needs: what your team already works with, the level they’re at, and the topics you want them to focus on. We’ll adjust the modules, duration and hands-on labs, and send you a customized outline for your group.
Key Skills and Outcomes Your Team Will Gain
Seven job-ready outcomes your team will demonstrate by the end of the program. Each competency is practiced in guided labs and reviewed in the capstone plan.
Interpret MDR and IVDR requirements
Read MDR and IVDR articles, scopes, and definitions and apply them to your own device portfolio and product changes.
Classify devices and IVDs
Apply MDR and IVDR classification rules to assign risk classes and defend the outcome with documented rationale.
Select conformity assessment routes
Choose the right conformity route, know when a notified body is required, and plan the engagement sequence.
Author technical documentation
Draft device descriptions, intended purpose statements, and GSPR checklists backed by structured evidence.
Run clinical and performance evaluation
Build clinical evaluation plans, literature appraisals, PMCF activities, and IVDR performance evaluation strategies.
Manage vigilance and post-market duties
Classify incidents, meet vigilance reporting timelines, and prepare FSCA actions and EUDAMED entries.
Deliver a transition compliance plan
Run portfolio gap assessments and present a sequenced MDR and IVDR transition plan with timelines and owners.
Teams that Benefit from this EU MDR and IVDR Medical Device Compliance Group Training
This group training is built for medical device and IVD teams managing EU market access who want reliable MDR and IVDR compliance skills. Content adapts to each cohort's roles, product classes, and experience, so every batch practices the workflows it owns, from classification to vigilance.
Steer submissions with MDR and IVDR confidence.
Regulatory professionals practice classification, conformity route selection, and dossier preparation against current EU expectations.
Workflow friction
- Shifting notified body expectations
- Legacy device transition pressure
- Dossier gaps found too late
How the program helps
- Confident classification decisions
- Route selection with rationale
- Submission-ready documentation
Practice use cases
- Classification labs
- Route selection drills
- Dossier review exercises
Align QMS evidence with regulatory review.
Quality teams map ISO 13485 records to MDR and IVDR evidence needs and strengthen CAPA and document control practice.
Workflow friction
- Audit findings on design controls
- CAPA backlogs and effectiveness
- Records scattered across systems
How the program helps
- QMS to submission traceability
- Stronger CAPA records
- Audit-ready documentation
Practice use cases
- QMS mapping labs
- CAPA drafting drills
- Audit prep walkthroughs
Design with regulatory outcomes in mind.
R&D teams learn to capture design inputs, evidence, and intended purpose wording that survive regulatory review.
Workflow friction
- Design history gaps discovered late
- Intended purpose wording disputes
- Evidence captured after release
How the program helps
- Review-ready design records
- Clear intended purpose drafting
- Early regulatory alignment
Practice use cases
- Design control labs
- Evidence capture drills
- Intended purpose practice
Cohorts train as a cross-functional workforce, with each small group aligned on shared regulatory vocabulary and documentation standards.
Prerequisites: This program benefits regulatory affairs, quality, R&D, and clinical teams working on medical devices or IVDs for the EU market. Basic familiarity with medical device development helps but is not required, and no prior MDR or IVDR experience is needed. Content adapts to each cohort's device classes, tools, and regulatory maturity.
Regulatory Associate to EU Medical Device Compliance Lead
Tracks how regulatory teams progress from basic MDR and IVDR literacy to advanced portfolio compliance practice across the program's learn, practice, and apply phases.
A program that grows with regulatory careers, from first classification exercise to confident portfolio compliance planning.
Mixed cohort, or several teams at once?
We can tailor the training to different teams, roles, and experience levels within the same program.
Certificate of Training Completion.
On successful completion, employees receive an Edstellar course completion certificate, recognizing their commitment to ongoing learning and professional development. It validates the skills they have built and motivates them to keep growing and contribute to organizational success.
Earned, not attended. Awarded on completion of all hands-on labs and the capstone project.
Training Delivery Modes: Virtual, Onsite and Hybrid
Choose how your team trains: live virtual, onsite at your offices, or hybrid. Every mode includes the same guided labs and dossier exercises.
Hybrid Training
Instructor-led sessions mix onsite and virtual delivery with guided labs throughout. Teams classify devices, draft dossier sections, and map QMS evidence while the instructor coaches and reviews their work. Hybrid keeps scheduling flexible without losing live interaction.
- Live instruction across onsite and virtual sessions
- Guided labs with instructor coaching and reviews
- Device classification and dossier labs throughout
- Flexible scheduling without losing live interaction
Onsite Training
Instructor-led training at your offices, with labs set up on your network and tooling. The instructor works through classification exercises and dossier drafts with the team in person and tunes examples to your device portfolio.
- Instructor-led training at your offices
- Labs set up on your network and tooling
- In-person review of dossier drafts
- Examples tuned to your device portfolio
Live Virtual Training
Live virtual sessions on Zoom or Teams with screen-shared labs, breakout exercises, and real-time instructor review. Your team gets the same classification and dossier labs as onsite, from anywhere.
- Live virtual sessions on Zoom or Teams
- Screen-shared labs and breakout exercises
- Real-time instructor review of lab work
- Same guided labs as onsite, from anywhere
Need a training format that works for your team?
Full days, half days across weeks, or split by module. Tell us the delivery window and we schedule the cohort around it.
Frequently Asked Questions
Share your team size, timelines, and delivery preference, and we will send a detailed per-group quote with batch options.
Yes. Book a discovery call and we will map your device portfolio, regulatory goals, and timelines to a tailored training plan.
Yes. Live virtual sessions run on Zoom or Teams with the same guided labs and instructor coaching as onsite delivery.
Yes. The instructor runs the full program at your offices, with labs set up on your network and tooling for a realistic environment.
The program runs 28 hours of instructor-led training, usually across four to seven days or weekly sessions on a flexible, mutually agreed schedule.
Question not answered here?
Put it in the request. A training specialist answers it directly, within one business day.
Where this Training Fits in Your Team's learning path.
EU MDR and IVDR compliance sits on top of a working quality system and a risk file, because notified bodies assess both. Your team builds the ISO 13485 QMS, manages device risk under ISO 14971, meets the European regulations, then extends that evidence to submissions in other markets.
Why Choose Edstellar as Your EU MDR and IVDR Medical Device Compliance Corporate Training Provider
When comparing providers, Edstellar is the training partner teams choose for regulatory expertise and 5+ years of corporate training experience. Our methodology blends concise instruction with guided labs, and we share each trainer profile before booking. The result is measurable compliance readiness across your device portfolio.
EXPERT TRAINERS
YEARS DELIVERING
ORGANIZATIONS TRAINED
CERTIFIED
Tailored
Every cohort's labs, device examples, and dossier exercises are tuned to your product classes, regulatory milestones, and workflows.
Proven Methodology
Concise instruction followed by guided labs and instructor reviews, a repeatable method that turns regulations into practiced skill.
Practice-Based Learning
Seven modules of guided labs and a capstone transition plan keep your team drafting, classifying, and reviewing, not just listening.
Expert Trainers
Practitioners who steer medical devices through MDR and IVDR submissions lead every session and review your team's work.
Global Scale
One consistent program delivered across your offices worldwide, so distributed regulatory teams build one shared standard.
Measurable Outcomes
Lab checkpoints and a capstone review prove regulatory skill gains you can report internally.
Connect Medical Device Classification to Technical Evidence and Post-Market Planning
Edstellar develops MDR and IVDR compliance practice through classification, conformity routes, technical dossiers, quality records, and clinical or performance evidence. Teams analyze fictional device portfolios and simulated vigilance cases before presenting a transition plan. The review assesses documentation consistency and unresolved evidence needs, without conferring device approval or authorizing clinical use.
- Step 01
Consult
We explore regulatory, quality, and development responsibilities, identifying gaps in device classification, conformity routes, dossier traceability, clinical evidence, and post-market incident handling.
- Step 02
Plan
We establish MDR and IVDR foundations before classification and technical documentation, then QMS evidence, clinical evaluation, and vigilance within the portfolio transition plan.
- Step 03
Align
We align device-regulatory facilitation with regulatory affairs, R&D, quality, and clinical teams, introducing framework concepts and tailoring evidence exercises to relevant device classes.
- Step 04
Customize
We tailor fictional device descriptions, GSPR checklists, audit findings, and vigilance scenarios to representative portfolios, excluding patient records and actual regulator submissions.
- Step 05
Execute
Participants justify classifications, map QMS records, outline evaluation plans, and draft mock notifications, receiving feedback on intended-purpose consistency, evidence gaps, and post-market responsibilities.
- Step 06
Evaluate
We assess the transition plan for coherent device and route decisions, traceable technical and quality evidence, and prioritized actions addressing clinical and post-market documentation needs.
Also from Edstellar
Talent assessments
Psychometric, behavioral, leadership and 360-degree assessment.
→Training needs analysis
Needs analysis, gap identification, and a training roadmap.
→L&D consulting
Learning strategy, content, technology and ROI measurement.
→OD consulting
Org design, succession planning and cultural change.
→Managed training services
Training outsourcing, vendor management, logistics and administration.
→Coaching solutions
Executive and manager coaching that keeps skills in use.
Start an RFP shaped to your needs.
Answer three quick questions about team size, scope, and how often you need the program run, then send the request from the last step. Everything you choose travels with it, so you only fill this in once.
How many team members need training?
EU MDR & IVDR Medical Device Compliance Training Packages & Pricing
Where L&D holds an annual budget, license packages price the whole year at once instead of raising a purchase order per workshop. Hours and licenses are pooled across teams, programs and locations, so unused capacity is not stranded in one department.
Starter
120
trainee licenses64 hours of group training
Tailored for SMBs
Growth
320
trainee licenses160 hours of group training
Ideal for growing SMBs
Enterprise
800
trainee licenses400 hours of group training
Designed for large corporations
Custom
Unlimited
trainee licensesDuration set by the rollout
Multi-region and multi-year
Training Packages & Pricing
Choose the training format that works for your team. Pricing is customized based on your requirements, cohort size, and delivery needs.
Request EU MDR and IVDR Medical Device Compliance Training for Your Team
Share your team size, device portfolio, regulatory milestones, and timelines to receive a tailored training plan and quote. Book a discovery call to discuss your goals; we confirm availability and respond with a proposal.