COURSE DESCRIPTION
Implementation of European Medical Device Regulations is the primary requirements while demonstrating the compliance to regulatory requirements while placing the products in European Market for the Medical Device manufacturers and to place CE marking on the products. The European Council Directives 90/385/EEC and 93/42/EEC has been revised to Regulation (EU) 2017/745. European Medical Devices Regulation (MDR), was published in the Official Journal of the European Union on May 5, 2017. The Regulation (EU) 2017/745, covers medical devices and active implantable medical devices.
This regulatory frame work defines the expectations of European Commission, as well as medical device manufacturers, notified bodies and member state competent authorities. The regulation published on 5 May 2017 will came into force from 26 May 2020
This two-day training course introduces you to the key changes from the European Medical Device Directive (MDD) to the new European Medical Device Regulation (MDR). All medical devices and identified devices without a medical purpose will need to undergo a conformity assessment procedure
based on the new MDR requirements, in order to place devices on the European Union market. The course will give a general guideline of how to approach application of the new MDR, and will highlight the differences to the MDD that will affect all manufacturers.
Objectives
This course will help you:
- Understand the key changes in the transition from the Medical Device Directive to the new Medical Device Regulation
- 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 requirement
What will participants learn?
Identify key changes to the requirements concerning the following steps for conformity assessment
- Check device is within the scope of MDR
- Determine risk class of device
- Select conformity assessment procedure
- Identify applicable safety and performance requirements
- Assemble technical documentation
- Post-market surveillance and updates
Who should attend?
Manufacturers of medical devices, especially: Regulatory Affairs, Design and Development, Clinical Affairs Specialists, Quality Management, and Quality Assurance personnel.
What is included?
- Training course materials with workshops
- Training certificate (successfully passed examination / attendance)