EU Medical Device Regulation (MDR) Online Overview
ObjectivesThe Irish Medtech Skillnet is delighted to join Comply Guru™ and Meddev Solutions in bringing to market this exciting new online self-paced general overview of the EU MDR course.
This Online & Self-Paced Basic Overview of the EU Medical Device Regulation (MDR 2017/745) Training Course is perfect for anyone working in the medical device industry sector who is looking for a general overview of the EU Medical Device Regulation and it can be completed anytime, anywhere!
This event is FULLY FUNDED under SKILLS CONNECT for UNEMPLOYED Job seekers who are currently seeking employment, subject to eligibility criteria.
Further details of Skills Connect and Skills Connect ELIGIBILITY CRITERIA can be found on the Skillnet Ireland Website
Content includesModule 1:
Introduction to the EU-MDR (Online & Self-Paced)
- Context for revision of MDD/ AIMDD/ IVDMD
- Purpose of EU-MDR
- Structure of EU-MDR
- Medical devices covered by EU-MDR
- Key changes introduced by EU-MDR
- Timelines for transition
Placing on the market (Online & Self-Paced)
- Overview of articles 10, 11, 13-15
- Role of the Manufacturer, Authorised Representative, Importer, Distributer and Person Responsible for Regulatory Compliance
- Overview of articles 5, 19, 20
- Brief overview of Classification, Conformity assessment, EU declaration of conformity and CE Marking
Who should attendAnyone interested in a general overview of the EU MDR.
- Anyone working in the Medical Device Industry
- Quality assurance professionals
- Quality Engineers
- Research and design Engineers
- Internal Auditors
- Quality Managers
- Manufacturing Engineers
- Regulatory professionals
QualificationSuccessful completion will entitle each Learner to receive a certificate of completion.
In order to successfully complete the course, each Learner will need to obtain a grade of 70% or higher in the final examination.
No training dates available at the moment.