Medical Device Regulatory Affairs Training
Medical Device Regulatory Affairs Training in Europe
Expanding into the European medical device market means navigating one of the most detailed and evolving regulatory frameworks in the world.
Whether you’re a manufacturer based in the EU or looking to enter the region, understanding the certification process and ongoing responsibilities is essential for market success.
Our medical device regulatory training in Europe is designed to help your team master the fundamentals and key updates of EU MDR, CE marking, risk management, and post-market requirements. With flexible formats and expert-led sessions, we empower your internal teams to handle regulatory challenges confidently.
How we support your Regulatory Training needs
Our regulatory affairs training for medical devices in the EU is delivered by experienced consultants and tailored to professionals at different stages of the regulatory journey. Trainings are available online or on-site, depending on your team’s preference and location.
We offer the following programs:
CE Marking Essentials: Introductory course covering the basics of CE certification and MDR requirements for medical devices.
CE Mark – Advanced: In-depth training focused on complex submission strategies, documentation, and post-market activities.
CE Mark – PRRC: Focused on the responsibilities and role of the Person Responsible for Regulatory Compliance under EU MDR.
MDR 2017/745: A practical training focused on the core regulatory framework for medical devices in the EU.
UK MDR 2002: Covers the UK-specific regulatory pathway and post-Brexit adjustments for medical device registration.
ISO 14971 – Risk Management: Training based on the ISO 14971 standard, with a focus on risk identification, evaluation, and control across the product lifecycle.
Each course is designed to answer real regulatory questions, help you interpret legislative texts, and improve your team’s confidence in managing compliance.
Why do you need this service?
Empower your team to manage registrations and post-market requirements with greater autonomy.
Gain a practical understanding of how to register medical devices in Europe, from classification to submission.
Well-trained teams make better regulatory decisions—saving time, reducing rework, and avoiding compliance gaps.
Our approach is hands-on and aligned with real-world regulatory needs, helping you build stronger internal capacity for compliance and communication with Notified Bodies.
This is why we deliver structured, relevant, and up-to-date training programs on medical device regulations in Europe.
We support companies of all sizes looking to train regulatory teams, QA specialists, product managers, and leadership involved in EU medical device regulatory affairs.
Looking for EU MDR Training for your Medical Device team?
Whether you’re seeking an introduction to CE Marking or a deep dive into MDR compliance, we offer the right course for your team. Let us help you prepare for the European market with clarity and confidence.
Get in touch with our team to explore the right training solution for your company and strengthen your regulatory expertise in the European medical device market.
