This 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?
- Senior management
- Regulatory, quality, design, development, manufacturing, marketing managers and
personnel - Organizations preparing "own branding" or "private labelling" of devices
What will I learn?
- 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 - 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.
What is included?
On completion, you will be awarded an internationally recognized BSI Training Academy certificate.
