Medical Devices Regulations

Course Description :

• I General safety and performance requirements
• II Technical documentation I
• II Technical documentation on post-market surveillance
• IV EU declaration of conformity
• V CE marking of conformity
• VI Information to be submitted upon the registration of devices including UDI system
• VII Requirements to be met by notified bodies
• VIII Classification rules
• IX Conformity assessment based on a quality management system and assessment of the technical documentation
• X Conformity assessment based on type examination
• XI Conformity assessment based on product conformity verification
• XII Certificates issued by a notified body
• XIII Procedure for custom-made devices
• XIV Clinical evaluation and post-market clinical follow-up
• XV Clinical investigations
• XVI List of groups of products without an intended medical purpose
• The MDR’s additional requirements • The current directives – MDD 93/42/EE and ISO 13485:2016 • Terminology and certification requirements
• Introduction to MDR
• Implementation timelines
• Regulatory expectations against various chapters
• Contents and Fundamentals of the Medical Device Regulation (MDR)
• Classification/Reclassification of Products
• Non-Medical Products within the Scope of the Medical Device Regulation (MDR)
• Common Technical Specifications
• New Basic Requirements
• Content Requirements for Technical Documentation
• Post Market Surveillance
• Scrutiny Procedure
• Validity of Conformity Assessment and Certification, Transition Periods
• Requirements for Different Actors, e. g.:
• Manufacturers
• Importers
• EU Representatives
• Distributors and Service Partners
• Role of Contact Person for Regulatory Compliance
• Eudamed Database
• UDI (Unique Device Identification)
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• This course is assessed by 1-hour multiple-choice open book assessment by end of the training day
• Trainees will receive A4 Certificate from NES.
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Free access this course
Enrolled :0

Who Should Attend

  • • Manufacturers of medical devices, especially:
  • • Regulatory Affairs,
  • • Design and Development,
  • • Clinical Affairs Specialists,
  • • Quality Management, and
  • • Quality Assurance personnel

Provider :


Lead Tutor :

Mohamed El Morsy

Location :


Duration :

3 Days

Schedule :

8-9-10 Jul.

Language :

English/ Arabic

Prerequisites :

No Required Prerequisites