CE Marking Introduction Training Course
This one day course will teach you how to start making informed decisions with regards to meeting the requirements of the EU Medical Devices Directives. On completion of the training, participants will be able to identify the steps required to reduce the risks and uncertainty in the EU regulatory process and thus save time bringing products to the EU market.
Who should attend?
This training course is HRDF approved under the SBL scheme. On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.
- Senior management
- Regulatory, quality, design, development, manufacturing, marketing managers and
- Organizations preparing "own branding" or "private labelling" of devices
What will I learn?
On completion of this training, participants will be able to:
- Explain the European CE marking approach with respect to medical devices, active
implantables and IVDs, including borderlines with other products, as covered by the three Council Directives (MDD, AIMDD, IVDD) and the underlying Commission Directives such as the animal tissue directive and blood derivative directives
- Prepare a clinical evaluation in accordance with MED DEV 2.7.1 and GHTF Guidance Documents
- Explain the significance of the EU risk classification criteria for medical devices in
determining the conformity assessment routes and quality assurance requirements for the various risk classes, as well as the routes to compliance for borderline products that include pharmaceuticals, human derivatives and/or engineered tissues
- Describe the role of the essential requirements as the basis for CE marking, including the use of standards
- Describe the role of clinical data and risk management
- Identify the necessary steps required for post market surveillance and for reporting adverse incidents under the vigilance system
- Identify technical documentation requirements.
How will I benefit?
- Benefit from CE Marking expertise within your organization
- Work without uncertainty when placing products on the EU market
- Gain recognition as a producer of products with CE Marking
- Improve the quality and safety of your medical devices
- Increase EU market access and boost customer confidence
Our unique accelerated approach fast-tracks learning, improves knowledge retention and ensures you get the skills to apply your knowledge straight away. This course involves practical activities as well as toolkits, templates and classroom learning to help you develop a deeper understanding of the material and have a greater impact on job performance.