Medical Device regulation (MDR) 2017/745

1 Day/s

CPD Hours: 7

Online, in-house

Compliance with the Medical Device Regulation (EU) 2017/745 (MDR) presents many new challenges to Medical Device manufacturers. Our in-depth MDR training is designed to help you and your team prepare for these challenges and transition smoothly to the MDR.

This course focuses on what is required to bring your Medical Device to market under Medical Device Regulation (EU) 2017/745 (MDR).

The course is intended for individuals that work for a Medical Device manufacturer or CMO who's responsibilities require them to have an understanding of Medical Device Regulation (EU) 2017/745 and the differences/issues from the current MDD. In particular Quality Management, Quality Assurance, Regulatory Affairs, Design and Development, Clinical Affairs Specialists, Authorized Representatives, Economic Operators, including importers and distributors.
The course covers the following topics :

  • Introduction to Regulation (EU) 2017/745 on Medical Devices “EU MDR”
  • Medical Device Terminology
  • Placing a Medical Device on the EU Market
  • Structure of Regulation (EU) 2017/745 – Chapters, Articles and Annexes
  • Chapter II – Placing on the Market, Use of Harmonised Standards, General Obligations of Manufacturers, Authorised Representative, Distributors, Importers, PRRC, D of C.
  • Chapter III – Identification and traceability of devices, registration of devices and Economic Operators, EUDAMED.
  • Chapter IV – Notified Bodies
  • ISO 14971:2019 – Medical devices – Application of risk management to medical devices
  • Chapter V – Classification and Conformity Assessment – Section 1 Classification
  • Chapter VI – Clinical Evaluation and Clinical Investigations
  • Chapter VII – Post-Market Surveillance, Vigilance and Market Surveillance
  • ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes
  • FDA 21 CFR Part 820 Quality System Regulation
  • Auditing Medical Device Manufacturers
  • Medical Device Standards
  • Medical Device Sterilisation, Packaging and Labelling
  • UK Legislation and UKCA Marking

    At the end the course, you will be able to:

    • Understand the key differences between MDD and the new MDR
    • Understand how to transition from MDD to MDR
    • Understand how to navigate the 2017/745/EU standards
    • Classifying medical devices under the European MDR
    • Safety and performance requirements
    • Identify the implementation steps required to meet MDR

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Bring this course in-house

Special offer

Helping your training budget go further

We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.

Meet the tutors

Lisa Banwell

Lisa Banwell is an experienced, technically qualified Quality and Regulatory consultant, working in regulated industries, including Medical Device manufacturing, Pharmaceutical Analysis and Fine Chemical manufacturing. She has specific experience in auditing, inspection management, Competent Authority communication and regulatory strategy and registration; her expertise spans infusion products, contact lens products, single use sterile medical devices, neurophysiological and vascular diagnostic/monitoring equipment.

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