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Two Day Online Seminar: Fundamentals of EU MDR and IVDR - Level 1, June 24-25, 2021 -

·3-min read

The "Fundamentals of EU MDR and IVDR - Level 1" conference has been added to's offering.

This 2 day seminar will go into the specifics of the European Union Medical Device Regulation (EU MDR) and the In Vitro Diagnostic Device Regulation (IVDR), provide case studies and share lessons learned so your organization can benefit from the mistakes of others.

We will review the latest changes to the regulations effective and in force for 2020 and will draw out key developments and key dates with particular emphasis on requirements for US firms shipping materials, parts, and products to the European Union.

Learning Objectives:

  • Reasons for the Medical Device Regulation

  • Structure and objectives of the MDR

  • Timeline for transition

  • Difference between the old requirements (MDD) and the new (MDR)

  • Ability to identify the lifecycle of a device and the requirements of the various stages - premarket, design and development, product realization, and post-market

  • Understand the impact of the regulation changes on "economic operators" (Articles 11, 13, 14)

  • How to transition from the old directives to the new regulation

  • Identifying high-risk devices

  • General safety and performance requirements (GSPR Annex 1)

  • Review Common Specifications (CS)

  • Connection between MDR and ISO 13485:2016

  • Technical file requirements and reviews

  • UDI and traceability

  • Linking to the Quality Management System (QMS)

  • Steps of a gap assessment "As Is" and "To Be" for transitioning to new compliance requirements

  • Basic understanding of the EUDAMED database for post-market surveillance

  • Preparing for transition to MDR

Areas Covered:

  • Objectives of the medical device regulation

  • Directives replaced with regulation

  • Risk-based device classification

  • Conformity assessment and its relevant changes (Annex IX, Annex X, Annex XI)

  • Requirements for technical documentation found in GSPR Annex 1

  • UDI and traceability requirements, responsibilities, and impacts (EUDAMED)

  • Process for clinical evaluations

  • Clinical evidence with supported documentation

  • Post-market requirements (Annex XIV and Annex 3 Part B)

  • Audit management and Notified Bodies requirements for manufacturers, as well as internal audit impact (Article 51, Annex V111)

  • Impact on the Quality Management System

Who Should Attend:

  • Manufacturers, distributors, and importers of medical device equipment

  • Quality and regulatory affairs

  • Product engineers focused on medical device products

  • Corporate risk management teams

  • Suppliers to medical device companies


Day 01 (8:00 AM - 2:00 PM PDT)

  • Introduction/review of Medical Device Regulation and timeline

  • Differences between the old and new version (MDD/MDR)

  • Lifecycle of a Device, Process pre and post-market

  • Transitioning to the new requirements

Day 02 (8:00 AM - 2:00 PM PDT)

  • Compliance procedures and Quality Management Systems

  • General safety and performance (GSPR) and Common Specifications (CS)

  • Integrating ISO 13485:2016; UDI; Technical file requirements

  • Preparing a Gap Assessment, Transitioning to MDR, and Understanding EUDAMED

For more information about this conference visit

View source version on

Laura Wood, Senior Press Manager

For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900

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