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 one 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).
- 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
You will learn about the:
- Changes in the structure and administration of the Regulation
- New Economic 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
We are now offering this training as online training course as well.