Course summary
Attend BSI’s “Introduction to CE Marking” one day course and start making informed decisions with regard to meeting the requirements of the EU Medical Devices Directives. On completion of training, participants will be able to identify the steps required to reduce the risks and uncertainty in the EU regulatory process and thus bring products to the EU market more quickly.
Learning Objectives
On completion of the training, participants will be able to:
• Explain the European CE marking approach with respect to medical devices, active implantable 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.
• 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.
Who should attend?
• Senior management
• Regulatory, quality, design, development, manufacturing, marketing managers and personnel.
• Organizations preparing ‘own branding’ or ‘private labelling’ of devices.
Prerequisites
There is no prerequisite from this course but participants will benefit from a basic knowledge of medical device use or manufacture.
Next steps
View our Medical Devices training course schedule.
For more information, please contact us or complete our enquiry form.
