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EU MDR Medical Device Regulation

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Course Overview
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  • Duration: 4 modules × 2 hours + 4 hours homework = 12 total hours

 

  • Target Audience: Regulatory affairs professionals, quality managers, manufacturers

 

  • Certificate: Professional Development Certificate of Completion

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Learning Outcomes

Upon completion, participants will be able to:

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  • Understand MDR structure and key requirements

  • Navigate classification and conformity assessment

  • Develop compliant technical documentation

  • Implement post-market surveillance obligations

Module 1:
MDR Foundation and Scope
(2 hours)

  • MDR structure and key changes from MDD

  • Device classification and rules

  • Economic operator responsibilities

  • Transition timelines and implementation

  • Homework (1 hour): Device classification exercise using MDR rules

Module 2: Conformity Assessment and Notified Bodies
(2 hours)

  • Conformity assessment procedures

  • Notified body selection and engagement

  • CE marking requirements

  • Declaration of conformity

  • Homework (1 hour): Conformity assessment route determination for case study devices

Module 3: 
Technical Documentation and Clinical Evidence
(2 hours)

  • Technical documentation requirements

  • Clinical evaluation and clinical data

  • Post-market clinical follow-up (PMCF)

  • Clinical investigation requirements

  • Homework (1 hour): Technical documentation gap analysis exercise

Module 4:
Post-Market Surveillance and Vigilance
(2 hours)

  • Post-market surveillance system requirements

  • Vigilance and adverse event reporting

  • Field safety corrective actions (FSCA)

  • Periodic safety update reports (PSUR)

  • Homework (1 hour): Post-market surveillance plan development

If you are interested in booking onto our next online course, please get in touch with us to discuss the next available dates.
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