In Vitro Diagnostic Regulatory Affairs Course

Name: In Vitro Diagnostic Regulatory Affairs Training Course
Availability: InStock

Advanced IVD regulatory strategy, classification, performance evidence, quality, market access, and post-market governance

This 1-week course has 76 dates from November 2026 to November 2027 in 54 cities and live online. The next date runs 16 – 20 November 2026, live online. Fees per participant run from €4,100 (Sharm El-Sheikh) to €14,000 (San Diego) in a classroom, and from €1,500 live online.

In Vitro Diagnostic Regulatory Affairs Course

Duration: 1 Week5 days
Next start: 16 November 2026Live online
Scheduled dates: 76
Classroom cities: 54Sharm El-Sheikh, Chicago, London, Dubai and more
Format: Classroom and live online
Fee per participant: €1,500–€14,000Average €5,750

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In Vitro Diagnostic Regulatory Affairs Training Course

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What does this course cover?

Overview

In Vitro Diagnostic Regulatory Affairs Training Course is a one-week advanced programme for professionals who plan, assemble, review, or maintain regulatory evidence for in vitro diagnostic devices. Participants connect intended purpose, qualification, classification, conformity assessment, quality management, risk management, performance evaluation, technical documentation, economic-operator responsibilities, market access, post-market surveillance, vigilance, and lifecycle change control. The course uses the European IVD regulatory framework as a structured case environment while requiring every participant to verify current jurisdiction-specific obligations with authorised regulatory and legal specialists.

Each participant develops an IVD Regulatory Pathway Dossier for a selected diagnostic product. The dossier brings together a regulatory strategy, classification rationale, evidence map, quality and risk interfaces, performance-evaluation plan, submission readiness review, surveillance design, and governance calendar. Agile Leaders Training Center presents regulatory affairs as a traceable lifecycle system rather than a one-time submission exercise.

Who Should Attend

Regulatory-affairs professionals responsible for diagnostic product strategy, submissions, registrations, and change assessment
Quality-assurance professionals maintaining an IVD quality management system and regulatory records
Clinical, scientific, and performance-evaluation teams responsible for analytical and clinical evidence
Risk-management and product-safety specialists linking hazards, controls, performance, and surveillance
Research, development, engineering, and product-management teams preparing IVD products for market
Manufacturing, supply-chain, and authorised-representative teams supporting economic-operator obligations
Internal auditors and compliance professionals reviewing regulatory readiness and lifecycle controls

This advanced course assumes familiarity with medical-device or diagnostic product development. It does not provide legal advice, certification, notified-body approval, or a jurisdiction-specific market authorisation.

Departments and Industries

The course supports in vitro diagnostic regulatory affairs across:

Regulatory affairs, quality assurance, clinical affairs, medical affairs, product safety, and compliance
Diagnostic manufacturers, laboratories, biotechnology companies, software-enabled diagnostic developers, and contract organisations
Importers, distributors, authorised representatives, research institutions, and healthcare technology organisations
Product development, manufacturing, supply chain, post-market surveillance, and executive governance functions

Learning Objectives

Map the IVD ecosystem, relevant actors, and regulatory responsibilities across the product lifecycle
Define intended purpose and document qualification and classification decisions
Select and justify a conformity-assessment and market-access pathway
Connect quality-system processes, risk management, and regulatory evidence
Structure analytical, clinical, and scientific performance-evaluation evidence
Plan technical documentation and conduct an evidence-readiness review
Design post-market surveillance, vigilance, trend reporting, and corrective-action interfaces
Govern regulatory changes, renewals, registrations, and continuing obligations

Practical Work Product

Participants build an IVD Regulatory Pathway Dossier containing:

Product and intended-purpose profile
Qualification and classification decision record
Actor and responsibility map
Conformity route and evidence requirements matrix
Quality and risk-management interface map
Performance-evaluation evidence plan
Technical-documentation readiness tracker
Post-market surveillance and vigilance framework
Regulatory change and governance calendar

Day 1: IVD Regulatory Ecosystem and Product Scope

Diagnostic product lifecycle and the roles of manufacturers, authorities, notified bodies, laboratories, representatives, importers, and distributors
Product concept, intended purpose, target population, specimen, user, setting, and claimed benefit
IVD qualification boundaries and interfaces with medical devices, laboratory-developed activities, research-use products, and software
Regulatory intelligence sources, controlled assumptions, and evidence traceability
Responsibility assignment through a regulatory actor map and decision log

Workshop: create the product profile, stakeholder map, and regulatory-question register for the IVD Regulatory Pathway Dossier.

Day 2: Classification and Market-Access Pathway

Risk-based classification logic and the evidence needed to support a classification rationale
Classification rules, special characteristics, companion diagnostics, self-testing, near-patient testing, and software considerations
Conformity-assessment routes and the consequences of product class for external assessment
Economic-operator readiness, registration, identification, labelling, and language considerations
Market-access sequencing, dependency mapping, and regulatory milestone planning

Workshop: produce a documented classification rationale, conformity route, and milestone map with explicit assumptions and escalation points.

Day 3: Quality, Risk, and Technical Documentation

IVD quality management system interfaces with design, suppliers, production, verification, release, complaints, and corrective action
Risk-management planning, hazard identification, risk controls, benefit-risk reasoning, and residual-risk communication
Traceability between intended purpose, requirements, risks, verification, validation, labelling, and claims
Technical-documentation architecture, document ownership, version control, and evidence-status tracking
Submission-readiness reviews, evidence gaps, remediation priorities, and governance checkpoints

Workshop: build a quality-risk-regulatory traceability matrix and a technical-documentation readiness tracker.

Day 4: Performance Evaluation and Evidence Governance

Scientific validity, analytical performance, and clinical performance as connected evidence streams
Performance-evaluation planning, acceptance criteria, data provenance, protocol controls, and report structure
Study governance, specimen considerations, bias, limitations, deviations, and evidence quality
Claim-evidence alignment and disciplined review of labels, instructions, promotional statements, and intended users
Evidence maintenance, literature monitoring, performance follow-up, and lifecycle updates

Workshop: create a performance-evaluation evidence map that links claims, endpoints, data sources, gaps, owners, and approval decisions.

Day 5: Post-Market Control and Regulatory Governance

Post-market surveillance planning, complaint inputs, performance signals, trend review, and periodic reporting
Vigilance assessment, reportability decisions, timelines, field actions, and authority communications
Corrective and preventive action interfaces with risk files, performance evidence, labelling, and product changes
Change assessment for design, supplier, manufacturing, software, intended purpose, claims, and market expansion
Regulatory governance dashboard, renewal calendar, management review, escalation, and audit readiness

Capstone: present and challenge the completed IVD Regulatory Pathway Dossier through a simulated cross-functional regulatory review board.

Training Methods

Facilitated regulatory pathway mapping and decision exercises
Diagnostic product case studies with incomplete or conflicting evidence
Classification, traceability, and performance-evaluation workshops
Cross-functional review-board simulation and peer challenge
Templates for evidence mapping, readiness tracking, surveillance, and change governance

Course Outcomes

Participants leave able to organise a defensible regulatory pathway, expose evidence gaps early, assign accountable owners, and maintain product compliance throughout the IVD lifecycle. They also leave with a practical dossier structure that can be adapted to their organisation only after review against current laws, guidance, quality procedures, and market-specific requirements.

Frequently Asked Questions

Does the course cover the European IVD regulatory framework?

Yes. It uses the European framework and related guidance as a structured learning environment, while distinguishing regulatory principles from advice for a specific product or market.

Is this an introductory IVD course?

No. It is designed for experienced professionals who need to integrate regulatory, quality, risk, performance, and post-market work into one governed pathway.

Does completing the course confer certification or market approval?

No. Course completion does not constitute certification, conformity assessment, regulatory authorisation, or legal advice.

What practical document will I produce?

You will build an IVD Regulatory Pathway Dossier containing the core decision records, evidence maps, readiness controls, and lifecycle governance tools developed during the one week.

credits: 5 credit per day

Course Mode: full-time

Provider: Agile Leaders Training Center

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When and where does this course run?

Showing 1-20 of 76 events

Location	Dates	Duration	Mode	Price
Zoom	Week 47, 2026 16 – 20 November 2026	1 Week	Online	€1,500
Sharm El-Sheikh	Week 48, 2026 23 – 27 November 2026	1 Week	Onsite	€4,100
Chicago	Week 48, 2026 29 November – 3 December 2026	1 Week	Onsite	€12,000
London	Week 49, 2026 30 November – 4 December 2026	1 Week	Onsite	€5,700
Dubai	Week 50, 2026 7 – 11 December 2026	1 Week	Onsite	€4,500
Amsterdam	Week 51, 2026 14 – 18 December 2026	1 Week	Onsite	€5,700
Nairobi	Week 51, 2026 20 – 24 December 2026	1 Week	Onsite	€4,500
Berlin	Week 52, 2026 21 – 25 December 2026	1 Week	Onsite	€5,700
Vienna	Week 53, 2026 28 December 2026 – 1 January 2027	1 Week	Onsite	€5,700
Athens	Week 53, 2026 28 December 2026 – 1 January 2027	1 Week	Onsite	€6,700
Istanbul	Week 02, 2027 11 – 15 January 2027	1 Week	Onsite	€4,500
London	Week 03, 2027 18 – 22 January 2027	1 Week	Onsite	€5,700
Vienna	Week 04, 2027 25 – 29 January 2027	1 Week	Onsite	€5,700
Abu Dhabi	Week 04, 2027 25 – 29 January 2027	1 Week	Onsite	€4,700
Dubai	Week 05, 2027 1 – 5 February 2027	1 Week	Onsite	€4,500
Munich	Week 06, 2027 8 – 12 February 2027	1 Week	Onsite	€5,700
Bali	Week 06, 2027 14 – 18 February 2027	1 Week	Onsite	€5,700
Frankfurt	Week 07, 2027 15 – 19 February 2027	1 Week	Onsite	€5,700
Langkawi	Week 07, 2027 21 – 25 February 2027	1 Week	Onsite	€6,000
Tashkent	Week 08, 2027 28 February – 4 March 2027	1 Week	Onsite	€4,500

Frequently asked questions

When does this course next run?

The next date runs 16 – 20 November 2026, live online. It is one of 76 dates scheduled up to November 2027.

Where is this course held?

In a classroom in 54 cities: Sharm El-Sheikh, Chicago, London, Dubai, Amsterdam, Nairobi, Berlin, Vienna, and more. It is also scheduled as live online sessions.

Can I attend this course online?

Yes. One date is scheduled as a live online session: 16 – 20 November 2026, from €1,500 per participant.

How long is the course?

1 Week. Each date shows its start and end dates.

How much does the course cost?

Fees per participant run from €4,100 (Sharm El-Sheikh) to €14,000 (San Diego) in a classroom, and from €1,500 live online. Each date shows its own fee.

What does this course cover?

Overview In Vitro Diagnostic Regulatory Affairs Training Course is a one-week advanced programme for professionals who plan, assemble, review, or maintain regulatory evidence for in vitro diagnostic devices. Participants connect intended purpose, qualification, classification, conformity assessment, quality management, risk management, performance evaluat…

Are training dates available?

Yes. Available dates and destinations are listed in the course dates section on this page.

How can I register?

Choose an available date on this page and complete the registration form, or send a programme enquiry.

Can I download the course brochure?

Yes. Use the brochure download link provided on this page.

Can this course be run for our team?

Yes. Tell us the number of participants and your preferred dates and city through our training request form.

In Vitro Diagnostic Regulatory Affairs Course