The Medical Devices Regulation (EU 2017/745) has replaced the Medical Devices Directive (93/42/EEC) as the legislation detailing the requirements that manufacturers have to meet to place medical devices on the market in the European Union.
This long awaited text brings with it more scrutiny of technical documentation, including clinical evaluation and post-market clinical follow-up, and traceability of devices through the supply chain.
Our 1-day training course has been designed to introduce medical device manufacturers and other economic operators in the supply chain to the key changes to requirements for CE marking following the publication of the new Medical Devices Regulation (MDR).
Online training courses: Connected Learning Live
You can attend this training course classroom based and online. Do you prefer the convenience of an online training course? View here for the available dates or read more about Connected Learning Live.
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How will I benefit?
On completion of this course, you will be able to:
- Understand the key changes in the transition from the MDD to the new MDR
- Communicate the impact to your organization of the key changes introduced by the MDR, and the transition arrangements defined within the MDR
- Identify the next steps for your organization to meet the MDR requirements
Who should attend?
- Medical device manufacturers, especially if your role is in:
• Regulatory Affairs
• Design and Development
• Clinical Affairs Specialists
• Quality Management
• Quality Assurance
- Authorized Representatives
- Economic Operators, including importers and distributors
- Consultants
Prerequisites
You should have a good understanding of the existing Medical Devices Directive (93/42/EEC).
What will I learn?
You will learn about the:
- Changes in the structure and administration of the Regulation
- New Eonomic Operators affected by the Regulation
- Key changes to the requirements
- Scope of the MDR
- Device classification
- Conformity Assessment Procedures
- Safety and Performance Requirements
- Requirements for technical documentation
- Unique Device Identifiers (UDI)
- Declaration of Conformity
- Post-Market Surveillance and vigilance
- Transition arrangements as stipulated within the Regulation
What's included?
- Training course notes
- Lunch for the classroom training
- Refreshments for the classroom training
| 1. Transition or Requirements MDD - MDR |
| 2. Implementing CE Marking MDR |
| Combination training courses 1 + 2 |
For more information about this course and/or the possibilities of an in-house training for your organization, please contact our Training Advisors on +31 20 346 0780 or send an email to training.nl@bsigroup.com.
