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EU MDR and IVDR: Key Updates and Compliance Strategies

This course provides practical direction for managing EU MDR and IVDR compliance obligations, helping organizations address 2025 regulatory changes, notified body expectations, EUDAMED requirements, and post-market surveillance responsibilities while reducing certification and market access delays. This Course is designed for professionals responsible for EU medical device and diagnostic compliance, certification, surveillance, and documentation.

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US $190 per learner

30-Days Unlimited Streaming Access

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REGISTER FOR THE COURSE

To Get 30-Day Access to ONLY this Course 

US $190 per learner
  • This course is Included in Subscription Pack
Subscription include access to entire Learning Library
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  • Instructor : Charles Paul
  • Study time : 90 Minutes
  • Skill Level: Intermediate
  • Course ID: TF3760
  • Assessment & Certification Included
  • Ask the Expert

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About the Course

EU MDR and IVDR requirements continue to shift as manufacturers manage extended transition periods, updated guidance documents, notified body capacity constraints, and expanding post-market obligations. Organizations marketing medical devices and in vitro diagnostics in the European Union must maintain current regulatory knowledge while addressing evolving expectations for clinical evidence, device traceability, vigilance reporting, and certification readiness. Delays in adapting compliance processes can affect submissions, product continuity, and regulatory timelines across multiple product categories and certification activities.


Current MDR and IVDR developments place additional attention on EUDAMED reporting responsibilities, UDI implementation, performance evaluation requirements, and ongoing post-market surveillance activities. Regulatory teams must also prepare for changing interpretations issued through European Commission and MDCG updates while managing technical documentation and audit preparation. This course provides focused regulatory context and practical compliance considerations relevant to 2025 deadlines, legacy device transitions, and day-to-day operational decision-making.

  • Managing Current MDR and IVDR Regulatory Expectations:

    Regulatory teams will strengthen their ability to interpret current MDR and IVDR updates, manage transition timelines, and prepare for notified body interactions with greater consistency. The course clarifies practical considerations tied to certification delays, evolving MDCG guidance, technical documentation expectations, and EUDAMED obligations that may affect ongoing product access within the European market.

  • Strengthening Post-Market and Reporting Readiness:

    Participants will gain clearer direction for handling post-market surveillance activities, vigilance reporting timelines, UDI responsibilities, and legacy device compliance decisions. The material also addresses the operational use of digital documentation tools and automation approaches that support regulatory tracking, audit preparation, and internal readiness as European compliance expectations continue changing through 2025.

Key Areas Covered

  • Key EU MDR and IVDR regulatory updates, transition timelines, and 2025 compliance expectations
  • European Commission and MDCG guidance developments affecting device and IVD manufacturers
  • Notified body capacity challenges, certification delays, and audit preparation considerations
  • UDI requirements, EUDAMED reporting obligations, and database implementation practices
  • Post-market surveillance activities, vigilance reporting timelines, and field safety corrective actions
  • IVDR classification changes, performance evaluation requirements, and legacy IVD device transition status
  • Gap analysis methods and conformity assessment preparation for MDR and IVDR compliance
  • Digital documentation tools, automation approaches, and regulatory tracking practices supporting compliance management

Who Must Attend

  • QA/QC Departments
  • Clinical Affairs Manager
  • Product Development Manager
  • Regulatory Affairs Departments
  • Compliance Professionals
  • Manufacturing Engineer

Quality training, expert insights, and answers that matter. Know your Expert

CHARLES PAUL

Charles Paul is an instructional designer and management consultant with more than 30 years of experience supporting regulated industries through training, consulting, quality system implementation, and GMP documentation development. His background includes work across pharmaceuticals, biotech, cosmetics, foods and beverages, and OTC consumer products. His experience developing operational documentation and compliance-focused training programs supports the regulatory and quality management topics. 

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Whether you’re looking for a single onsite workshop or a multi-team training series, we’ll help you design a program that fits your goals, timelines, and operational reality.

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Your organization deserves the confidence.

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Our students love us ❤️

“Covered the regulatory updates in a practical way without making it overly technical."



Clinical Affairs Manager

“Presenter explained the compliance expectations clearly and stayed focused on operational impact."


Manufacturing Engineer

“Good overview of the current MDR and IVDR changes. The sections on documentation and reporting expectations were especially useful for internal discussions.”

Manager, QC

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