Certificate in EU MDR Essentials

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The Certificate in EU MDR Essentials is a comprehensive course designed to provide learners with a solid understanding of the European Union Medical Device Regulation (EU MDR). This course highlights the importance of MDR in ensuring patient safety and product compliance in the EU medical device industry.

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AboutThisCourse

With the increasing demand for medical devices and the evolving regulatory landscape, this course equips learners with essential skills to navigate the complexities of EU MDR and advance their careers. The course curriculum covers key topics such as MDR requirements, classification rules, technical documentation, clinical evaluation, post-market surveillance, and vigilance. Learners will gain practical knowledge and skills through real-world case studies, interactive exercises, and quizzes. By earning this certification, learners demonstrate their commitment to upholding the highest standards of safety and compliance in the EU medical device industry, making them highly attractive to potential employers.

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CourseDetails

• Introduction to EU MDR: Overview of EU Medical Device Regulation, its purpose, and benefits
• Key Changes in EU MDR: Comparison of MDD (Medical Device Directive) vs. MDR, highlighting major updates
• Classification of Medical Devices: Understanding the risk-based classification system in EU MDR
• Clinical Evaluation and Investigations: Importance, requirements, and guidelines for clinical evaluation and investigations under EU MDR
• Technical Documentation: Preparing, maintaining, and updating technical documentation in compliance with EU MDR
• Unique Device Identification (UDI): Understanding the principles, requirements, and implementation of UDI system in EU MDR
• Vigilance and Post-Market Surveillance: Implementing effective vigilance and post-market surveillance systems as per EU MDR
• Notified Bodies and Conformity Assessment: Roles, responsibilities, and selection of Notified Bodies, as well as the conformity assessment process in EU MDR
• Brexit and EU MDR: Impact of Brexit on EU MDR and implications for medical device manufacturers

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EntryRequirements

  • BasicUnderstandingSubject
  • ProficiencyEnglish
  • ComputerInternetAccess
  • BasicComputerSkills
  • DedicationCompleteCourse

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  • NotAccreditedRecognized
  • NotRegulatedAuthorized
  • ComplementaryFormalQualifications

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CourseFee

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FastTrack GBP £149
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AcceleratedLearningPath
  • ThreeFourHoursPerWeek
  • EarlyCertificateDelivery
  • OpenEnrollmentStartAnytime
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StandardMode GBP £99
CompleteInTwoMonths
FlexibleLearningPace
  • TwoThreeHoursPerWeek
  • RegularCertificateDelivery
  • OpenEnrollmentStartAnytime
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  • FullCourseAccess
  • DigitalCertificate
  • CourseMaterials
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CERTIFICATE IN EU MDR ESSENTIALS
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UK School of Management (UKSM)
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05 May 2025
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